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Exploring The 22 Best Clinical Trial Management Software Of 2024

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Navigating the complex world of clinical research can feel like a Herculean task. Clinical Trial Management Software (CTMS) serves as an essential tool, simplifying this intricate process by offering an end-to-end, web-based solution. It’s a valuable asset to any research organization, pharma startup, or biotech company looking to streamline its clinical data management and trial […]

10 Best Clinical Trial Management Software Shortlist

Here's my pick of the 10 best software from the 22 tools reviewed.

• 1. Florence eTMF — Best for document management and streamlined trial collaboration
• 2. Citeline — Best for global clinical trial solutions and comprehensive market analysis
• 3. Calyx — Best for integrated trial management and regulatory compliance
• 4. Vial — Best for user-friendly interfaces and trial execution
• 5. Advarra — Best for multi-site trials and compliance management
• 6. Clario — Best for comprehensive trial enablement and management
• 7. RealTime Software Solutions — Best for real-time tracking of clinical trials and participant management
• 8. ResearchManager — Best for collaborative research and workflow management
• 9. Viedoc — Best for robust data management and trial design
• 10. Medrio — Best for decentralized clinical trials and data collection

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Navigating the complex world of clinical research can feel like a Herculean task. Clinical Trial Management Software (CTMS) serves as an essential tool, simplifying this intricate process by offering an end-to-end, web-based solution.

It's a valuable asset to any research organization, pharma startup, or biotech company looking to streamline its clinical data management and trial supply management. The built-in API also provides flexibility for custom integrations, enhancing interactions among stakeholders, and improving contract research organizations' output. Let's dive into some remarkable options that are primed to help you manage your clinical conductor duties with efficiency and compliance at the forefront.

What Is a Clinical Trial Management Software?

Clinical trial management software is a powerful tool that aids researchers, clinicians, and other healthcare professionals in planning, executing, and managing clinical trials. Often used by pharmaceutical and biotechnology companies, research institutions, and medical device manufacturers, these systems streamline the complex processes associated with clinical trials.

Using a CTMS, you can leverage its cloud-based system to store and manage patient data, monitor enrollment, and coordinate activities across different research sites. Particularly valuable features include eCRF and eCOA, as well as eConsent and eSource functionalities that provide a comprehensive audit trail. With features like templates, financial management tools, messaging, notifications, and mobile app accessibility, it offers you an efficient way to manage your clinical study.

With features like data collection and analysis, regulatory compliance tracking, participant management, and more, they serve to improve efficiency, enhance collaboration, and ensure the integrity and accuracy of trials. The end goal is a more structured, organized, and reliable approach to conducting and managing clinical research, driving innovation in healthcare and medical fields.

Best Clinical Trial Management Software Summary

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Best Clinical Trial Management Software Reviews

Florence eTMF

Best for document management and streamlined trial collaboration

• Pricing upon request.

Florence eTMF is a dedicated tool that focuses on facilitating efficient document management and fostering improved collaboration within clinical trials. Its robust document-handling capabilities and collaborative features make it an ideal solution for document management and streamlined trial collaboration.

Why I Picked Florence eTMF: Florence eTMF earned its spot on this list primarily because of its emphasis on simplifying document management and enhancing collaboration within clinical trials. It stands out with its dedicated tools for managing documents and facilitating communication between trial participants.

Because of these reasons, I consider Florence eTMF to be the 'Best for document management and streamlined trial collaboration.'

Standout Features & Integrations:

Florence eTMF shines with features like its centralized document repository, which provides an organized, easily accessible hub for all trial documents. It also offers robust collaboration tools designed to streamline communication and coordination between team members.

Integration-wise, Florence eTMF integrates well with a range of commonly used software in the clinical trial space, including data management, project management, and communication tools.

• Check out Florence eTMF on their website

Pros and cons

• Effective integrations with other clinical trial tools
• Robust collaboration tools for improved trial coordination
• Centralized document repository for efficient management
• Learning curve may be steep for less tech-savvy users
• May be too specialized for some users, lacking broad trial management features
• Lack of transparent pricing information

Best for global clinical trial solutions and comprehensive market analysis

Citeline provides solutions for global clinical trials and in-depth market analysis. The platform aggregates and analyzes data from a myriad of sources, enabling users to keep track of clinical trials worldwide and conduct comprehensive market research.

These abilities make it an exceptional choice for businesses operating or observing trials on a global scale.

Why I Picked Citeline: In selecting Citeline, its strength in providing a broad view of global clinical trials and offering comprehensive market analysis stood out. Judging by its comprehensive dataset and analytical capabilities, Citeline provides unmatched insights into global clinical trials.

This specificity and focus make it the 'Best for global clinical trial solutions and comprehensive market analysis.'

Citeline offers a comprehensive data set of global clinical trials and a suite of tools to analyze and visualize that data. Additionally, it integrates well with various business intelligence tools, extending the power of data analysis and reporting capabilities.

• Check out Citeline on their website
• Effective integrations with business intelligence tools
• Comprehensive market analysis tools
• Provides data on global clinical trials
• Focus on global data may not be useful for localized operations
• Can be complex for new users
• Absence of transparent pricing information

Best for integrated trial management and regulatory compliance

Calyx provides a comprehensive clinical research platform that combines trial management and regulatory compliance functionality. This makes it a versatile tool for ensuring organized, compliant research practices and makes it a top choice for integrated trial management and regulatory compliance.

Why I Picked Calyx: In deciding on this list, Calyx emerged as a preferred option because of its unique integration of trial management with regulatory compliance mechanisms. It's distinctive in its approach, providing a holistic solution to trial management that considers regulatory needs.

This blend of functionality made me see Calyx as 'Best for integrated trial management and regulatory compliance.'

Key features of Calyx include its extensive trial management tools and robust compliance tracking capabilities. Furthermore, it provides an integrated electronic data capture system for seamless data management. It offers important integrations with data management and visualization tools that enhance its trial management capabilities.

• Check out Calyx on their website
• Seamless data management through integrated electronic data capture
• Extensive management tools
• Integrated trial management and regulatory compliance
• Certain features may exceed the needs of small-scale trials
• Might be complex for users new to clinical trial management
• Lack of transparent pricing

Best for user-friendly interfaces and trial execution

• From $120/user/month, (billed annually).

As a software solution for clinical trial management, Vial offers a blend of simplicity and robust functionality. Its design caters to user-friendliness, making it a valuable tool for individuals and teams who prioritize ease of use and effective trial execution.

Why I Picked Vial: In my evaluation process, Vial stood out due to its intuitive interface and efficient execution of trial processes. Its attention to user experience, paired with its solid feature set, sets it apart in the crowded field of clinical trial software. Its strengths in user-friendly interface design and trial execution made it a clear choice for this list.

Vial boasts a variety of important features, such as participant tracking, data capture, and analysis, as well as comprehensive trial execution tools. Noteworthy integrations include connections to laboratory systems, electronic health records, and other trial-related software, which further enhance its capabilities.

• Check out Vial on their website
• Integration with a variety of trial-related systems
• Comprehensive trial execution tools
• User-friendly interface for easy navigation
• Pricing may be steep for smaller research teams
• Interface may be too simplistic for users desiring complex features
• Annual billing may limit flexibility for some users

Best for multi-site trials and compliance management

Advarra is a platform built to aid clinical trial management across multiple sites. It also includes advanced tools for regulatory compliance, making it a sound choice for organizations seeking to manage complex, multi-site clinical trials while adhering to all necessary rules and regulations.

Why I Picked Advarra: I chose Advarra because of its emphasis on multi-site trial management and compliance. When compared to other clinical trial management tools, Advarra stood out due to its robust features and specific focus on managing trials across multiple sites while maintaining compliance. Therefore, I determined it to be the best tool for this specific use case.

Advarra provides features like comprehensive multi-site trial management, regulatory compliance tools, and robust reporting functionalities. It integrates smoothly with many EDC systems, data analysis tools, and document management platforms, enabling a connected and streamlined workflow.

• Check out Advarra on their website
• Seamless integrations with other clinical trial tools
• Strong emphasis on regulatory compliance
• Comprehensive features for multi-site trial management
• The user interface may have a steep learning curve for some users
• Could be complex for smaller trials or single-site management
• Pricing information is not easily accessible

Best for comprehensive trial enablement and management

• From $130/user/month, (min 5 seats).

Clario is a comprehensive clinical trial management software that offers a powerful suite of features for trial enablement and management. It provides a streamlined, organized approach to clinical research, making it an optimal choice for those who require full control and oversight of their trials.

Why I Picked Clario: I chose Clario for its comprehensive approach to trial enablement and management. Its robust feature set, coupled with its ability to manage all aspects of a clinical trial, make it a unique choice among other software options.

Clario's strength in comprehensive trial enablement and management makes it best suited for this role.

Clario comes packed with essential features including robust data collection and analysis, regulatory compliance tracking, and participant management. As for integrations, it provides compatibility with major electronic health records systems, laboratory systems, and other clinical trial software, enabling a more interconnected trial process.

• Check out Clario on their website
• Good integration with other clinical systems
• Robust data collection and analysis
• Comprehensive suite of features for trial enablement and management
• Slightly higher starting price compared to some other options
• A minimum of five seats required for the basic package
• Might be overwhelming for smaller teams due to its extensive features

RealTime Software Solutions

Best for real-time tracking of clinical trials and participant management

• From $50/user/month, (billed annually).

RealTime Software Solutions brings a fresh perspective to the clinical trials management space with its emphasis on real-time tracking and participant management. The software's capabilities extend from patient recruitment to data management, all in real-time.

Why I Picked RealTime Software Solutions: I chose RealTime Software Solutions based on its emphasis on real-time monitoring and participant management. This focus allows the software to provide an immediate snapshot of trial progress and participant status, an aspect not all competitors offer.

Given this, RealTime Software Solutions stands as the best for real-time tracking and participant management in clinical trials.

RealTime Software Solutions excels in offering features such as instant trial monitoring, patient recruitment, and management, and streamlined data management. When it comes to integrations, the platform offers significant compatibility with EDC systems, patient recruitment tools, and data analytics solutions, among others.

• Check out RealTime Software Solutions on their website
• Diverse integrations with other healthcare and trial systems
• Strong focus on participant management
• Real-time monitoring capabilities enhance trial oversight
• Pricing might be steep for some budgets
• May be complex for small teams or beginners in clinical trial management
• Only offers annual billing, not monthly

ResearchManager

Best for collaborative research and workflow management

ResearchManager is a dynamic platform designed to streamline the research process and facilitate collaboration. It allows users to manage their research workflows effectively while promoting teamwork among researchers, thereby making it suitable for collaborative research and workflow management.

Why I Picked ResearchManager: I chose ResearchManager for its unique capability to blend workflow management with a collaboration-friendly environment. In making this selection, I observed that ResearchManager stands out for its focus on enabling smooth cooperation between research team members while keeping workflows organized and efficient.

This uniqueness solidifies its position as 'Best for collaborative research and workflow management.'

ResearchManager provides a suite of tools for managing workflows, data collection, and storage. The platform also boasts of a strong collaborative feature set that includes real-time data sharing and multi-user project management. It integrates effectively with standard data analysis and project management tools, enhancing its usability.

• Check out ResearchManager on their website
• Effective integrations with analysis and project management tools
• Real-time data sharing
• Emphasizes collaborative work and workflow management
• Collaboration features may be overkill for small-scale or solo research projects
• Steep learning curve for beginners

Best for robust data management and trial design

• From $150/user/month, (min 5 seats).

Viedoc stands as a powerful software dedicated to streamlining and strengthening data management and trial design for clinical research. Its robust suite of features and user-friendly interface make it an optimal choice for researchers and institutions needing an intuitive yet robust solution for their clinical trials.

Why I Picked Viedoc: I selected Viedoc due to its unique ability to integrate complex data management systems with a comprehensive trial design toolkit. Its capacity to handle large volumes of data with precision sets it apart from its peers. Viedoc's superior functionality makes it ideal for robust data management and intricate trial design, two critical factors in successful clinical research.

Viedoc includes data collection, patient engagement, trial design, and electronic data capture features. Its analytics capabilities ensure an efficient and accurate understanding of trial data. Notable integrations include connections to medical imaging systems, laboratory systems, and electronic medical record systems, further enhancing its utility.

• Check out Viedoc on their website
• User-friendly interface with intuitive navigation
• High-volume data handling capabilities
• Comprehensive data management and trial design functionalities
• May have more features than smaller trials require
• Minimum of five seats required for the basic package
• Starting price may be higher than some competitors

Best for decentralized clinical trials and data collection

Medrio is a clinical trials management tool that specializes in decentralized trials and data collection. The platform supports data collection from multiple sources, and its decentralization capabilities enable remote management of clinical trials, which is key in an era when remote work is increasingly common.

Why I Picked Medrio: I selected Medrio for its focus on decentralized trials and robust data collection. These two areas of focus are becoming more important in clinical trial management due to increasing trends toward remote work and data-driven decision-making. Thus, Medrio shines in this area and is, in my view, the best tool for decentralized clinical trials and data collection.

Key features of Medrio include its comprehensive data collection tools, support for decentralized clinical trials, and an intuitive user interface that simplifies complex processes. Medrio integrates seamlessly with a variety of data analysis tools, and EDC systems, and also supports direct data imports from various sources.

• Check out Medrio on their website
• Seamless integrations with data analysis tools
• Robust data collection and management capabilities
• Emphasis on decentralized clinical trials makes it ideal for remote teams
• Its strong focus on decentralization may not suit all trial management styles
• May have a learning curve for those not familiar with decentralized trials
• Pricing is not publicly available, which could deter some users

Other Clinical Trial Management Software

Best for electronic trial master file (eTMF) management

Best for optimized clinical operations and study management

Good for paperless clinical trial management

Good for enterprise-level clinical trial management

Good for comprehensive trial management solution

Good for user-friendly electronic data capture

Good for scalable clinical trial management systems

Good for open-source clinical trial solutions

Good for mobile data capture in clinical trials

Good for medical technology clinical trials

Good for decentralizing clinical trials

Good for integrating multiple clinical trial systems

Selection Criteria For Clinical Trial Management Software

When it comes to clinical trial management software, the nuances of each platform can significantly impact a team's efficacy and the overall success of a study. I've extensively tested and researched a multitude of these tools, and I've been particularly vigilant about certain key aspects that can enhance or hinder a research team's work.

Core Functionality

A competent clinical trial management software should enable users to:

• Conduct data collection and management efficiently
• Facilitate patient recruitment and retention
• Coordinate site management
• Streamline trial monitoring
• Oversee inventory management

Key Features

For this niche, the following features matter the most:

• Electronic Data Capture (EDC) : A tool that allows the collection of clinical trial data in an electronic format is a must for real-time, accurate data monitoring.
• Randomization : This feature helps balance patient allocation across different trial arms, ensuring the validity of the study.
• Electronic Patient-Reported Outcomes (ePRO) : An essential feature for collecting patient responses or feedback directly.
• Regulatory Compliance Management : Tools with this feature ensure that all data and processes comply with necessary regulations like HIPAA, GCP, and GDPR.
• Study Designing : A tool should allow users to design their study layout according to their specific requirements.

When it comes to usability, the following factors are significant:

• Intuitive Interface : Clinical trial software needs to have a clear, easy-to-navigate layout that allows users to quickly find and access different modules of the platform.
• Scalability : The ability to handle increasing amounts of work and accommodate growth is crucial, especially for larger trials or expanding organizations.
• Role-Based Access Control : A system that allows admins to limit access based on user roles is key for maintaining data integrity and confidentiality.
• Training and Support : Given the complexity of clinical trials, having readily available and responsive customer support, along with comprehensive training resources, is essential.

Most Common Questions Regarding Clinical Trial Management Software (FAQ's)

What are the benefits of using clinical trial management software.

Clinical trial management software offers multiple benefits, including:

• Efficiency : By automating various tasks, these tools reduce manual labor, save time, and streamline workflow.
• Data Accuracy : Digital data collection minimizes errors associated with manual data entry, thus ensuring data accuracy.
• Collaboration : These platforms offer a central hub for all trial-related activities, fostering better communication and collaboration among teams.
• Regulatory Compliance : Built-in compliance features help maintain adherence to regulatory standards like HIPAA, GCP, and GDPR.
• Real-Time Monitoring : The software allows real-time monitoring of trial progress, facilitating timely intervention and decision-making.

How much does clinical trial management software cost?

The cost of clinical trial management software varies significantly based on the size of the clinical trial, the number of users, and the specific functionalities required. Some providers offer tiered pricing, where you pay per user per month, while others may charge a flat rate.

What are the pricing models for these tools?

Typically, vendors offer several pricing models:

• Per User/Month : You pay a certain amount for each user every month.
• Per Study : You pay a one-time fee for each study conducted using the software.
• Flat Rate : You pay a flat monthly or annual fee for unlimited access to the software.

What is the typical range of pricing?

Prices can range from $25/user/month for basic packages to several thousand dollars per month for enterprise-level solutions that offer advanced features.

What is the cheapest and most expensive software?

The cheapest paid software can start as low as $25/user/month, such as TrialKit, while the most expensive ones like Oracle Clinical can cost several thousand dollars per month, especially for larger clinical trials or for more complex features.

Are there any free clinical trial management software options?

Yes, there are a few free options available like OpenClinica, which offers a free version of their software. However, these free options often have limitations on features and user capacity and are best suited for small-scale trials or for initial exploratory use before transitioning to a paid solution.

Other Clinical Management Software Reviews

• Medical Lab Software
• Patient Engagement Software
• EMR Systems
• Patient Case Management Software

In conclusion, selecting the ideal clinical trial management software relies heavily on understanding your unique needs and trial requirements. Such software offers substantial benefits like streamlined workflows, data accuracy, enhanced collaboration, regulatory compliance, and real-time monitoring of trial progress. However, the perfect tool for one organization may not be the same for another.

Key Takeaways

• Define Your Requirements : Clarify what specific functionalities, features, and compliance standards your trial necessitates. Do you need document management capabilities? Are integrations with existing systems critical? Answering these questions helps narrow down suitable options.
• Consider User Experience : Software usability significantly affects team productivity and software adoption rates. Seek software with a user-friendly interface, easy onboarding, and good customer support. Role-based access, an intuitive dashboard, and simple navigation are crucial aspects of clinical trial management software.
• Budget Appropriately : Pricing varies widely among these tools. Understand the pricing model that aligns best with your budget and the scale of your trials. While affordability is essential, ensure not to compromise on crucial features for the sake of cost savings. Some vendors offer free versions or trials, which are worth exploring before committing to a paid plan.

Navigating the landscape of clinical trial management software may seem daunting, but armed with the right knowledge and clear objectives, you can make an informed decision that will significantly improve your clinical trial processes.

What Do You Think?

Of course, this guide is not exhaustive, and the world of clinical trial management software continues to evolve with new tools and solutions entering the market. If you've come across an excellent tool that wasn't included in this list or have personal experiences with the tools I've mentioned, I invite you to share your insights. Your contributions could help others make more informed decisions in their quest for the perfect clinical trial management software.

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Scaling up: How work management solutions support clinical trial management software

As clinical trials grow in complexity, traditional clinical trial management software (CTMS) can fall short. Discover how integrating work management solutions can provide the missing piece to scale operations and keep clinical research operations on track.

Consider a global pharmaceutical company launching a complex adaptive trial in oncology. Their clinical trial management software flawlessly tracks patient data, but as the trial expands to more sites, the team drowns in emails and misses deadlines.  

Meanwhile, a midsized contract research organization (CRO) juggles five concurrent trials across different therapeutic areas. Their CTMS efficiently manages individual study data, but as they take on more clinical studies, resource allocation becomes a nightmare, causing delays and budget overruns. In both scenarios, as teams attempt to scale their clinical research operations, they quickly realize the limitations of traditional CTMS.

This article explores how project management platforms can complement CTMS, providing the framework needed for research organizations to scale operations smoothly, optimize resource allocation , and keep complex clinical studies on track in today's dynamic research landscape.

Scale clinical trials efficiently

Improve data accuracy, reduce trial delays, and deliver better health outcomes faster.

What is clinical trial management software (CTMS)?

Clinical trial management software, commonly known as CTMS, is a specialized software system designed to support every stage of clinical trials, from planning to implementation and administration. CTMS serves as a central hub for study management, helping research organizations streamline their workflows and improve operational efficiency.

However, as trials expand and organizations juggle multiple studies, traditional clinical trial management software may struggle with challenges like cross-site collaboration and resource allocation—issues that often require additional solutions to effectively scale clinical research management operations.

Key components of modern CTMS

Modern clinical trial management software typically features a range of essential eClinical tools and functions, working together to offer a complete solution for managing various aspects of clinical trials.

Study startup tools

Study startup tools help streamline the initial phases of a clinical trial. For example, a CTMS might include a regulatory document tracking system that ensures all necessary approvals are obtained before the trial begins. This could involve automated checklists for regulatory requirements, such as IRB approvals or FDA submissions, that help expedite the study startup process while maintaining compliance.

Document management systems

An efficient document management system is helpful for organizing and tracking the vast amount of paperwork associated with clinical studies. For instance, a CTMS might offer an electronic Trial Master File (eTMF) that stores and organizes all essential trial documents. This system could include version control, audit trails, and role-based access controls to ensure proper handling of sensitive clinical trial data.

Electronic data capture (EDC) capabilities

EDC systems allow for accurate data collection directly from research sites. For example, a clinical trial management system with integrated EDC functionality might enable site staff to input patient data directly into electronic case report forms (eCRFs). This real-time data entry can significantly improve data quality and reduce the time required for data cleaning and validation.

Financial management features

CTMS software often includes tools for managing the financial aspects of clinical trials. This could include budgeting tools that help forecast trial costs, track expenses, and manage invoicing. For instance, a CTMS might automate payments to research sites based on completed patient visits, which ensures timely and accurate financial management.

Reporting and dashboards

These features provide real-time insights into trial progress and performance. Clinical trial management software might offer customizable dashboards that display key performance indicators (KPIs) such as patient enrollment rates, data quality metrics, or milestone completion status. These visual tools enable study teams and stakeholders to quickly assess trial progress and make informed decisions.

Comparing clinical trial management software vs clinical trial management systems

While the terms are often used interchangeably, there can be subtle differences between clinical trial management software and a clinical trial management system. The former may refer to standalone applications, while the latter often implies a more integrated, end-to-end enterprise solution. However, both are designed to support clinical trial operations.

Scaling challenges for clinical research management teams

As clinical studies expand, teams face complex challenges. Pharma studies are drowning in emails across multiple sites and mid-sized CROs struggle with resource allocation for simultaneous trials, highlighting the shortcomings of traditional clinical trial management software.

1. Standardizing processes and ensuring compliance across multiple sites and regions

Maintaining consistent procedures, data collection methods, and regulatory compliance across different research sites and regions is essential for ensuring data quality and trial integrity.

Example: A global CRO managing a multi-center trial for a new cancer treatment might struggle to ensure uniform patient assessment protocols across sites in different countries, while also navigating varied regulatory requirements from bodies such as the FDA, EMA, and PMDA.

2. Overcoming fragmented communication and collaboration in multi-site trials

Clear communication and seamless collaboration are essential for successful clinical research, regardless of the locations and departments involved.

Example: A large-scale vaccine trial conducted across multiple countries faces challenges in maintaining clear communication between its on-site teams, remote data analysts, and regulatory affairs specialists, causing poor collaboration and decision-making delays.

3. Optimizing project tracking and resource allocation across multiple trials

Managing interdependent timelines and balancing personnel and budget effectively across multiple clinical trials is a significant challenge, particularly for research teams managing several studies simultaneously.

Example: A biotech company conducting parallel trials for different indications of a novel drug struggles with both progress monitoring and resource allocation. Without an intuitive tracking system, they face delays in submissions to regulatory bodies. Simultaneously, they grapple with optimally distributing their limited pool of clinical research associates across the various studies, leading to overallocation in some trials and resource gaps in others.

6 ways work management platforms improve clinical trial management software

As clinical studies grow in complexity and scale, traditional clinical trial management software struggles to meet the diverse challenges faced by research organizations, from standardizing processes and optimizing resources to supporting seamless communication.

By integrating work management platforms like Asana with CTMS, clinical trials can effectively tackle scaling hurdles. Let's explore how these work management tools improve clinical research management.

1. Provides a unified communication platform

Cloud-based, configurable work management tools can centralize all project-related communications, reduce fragmentation, and facilitate alignment across global research studies. These platforms offer flexible, accessible communication channels that can be tailored to the specific needs of diverse research organizations.

2. Offers powerful project tracking capabilities

These tools provide robust timeline and task management capabilities, enabling efficient tracking of milestones and deadlines. They can also automate routine administrative tasks like scheduling site visit reports, freeing up time for more critical activities like randomization and data management.

3. Enhances data visualization and project planning

Work management platforms offer powerful visualization tools like Gantt charts , Kanban boards , and calendar views. These modules integrate seamlessly with clinical trial data management software, providing clear overviews of project timelines , dependencies, and resource allocation. Gantt charts , in particular, are invaluable for mapping out complex trial processes, identifying potential bottlenecks, and adjusting timelines in real-time.

4. Streamlines resource management across trials

Work management software can help balance personnel and budget across trials, providing tools for capacity planning and workload balancing for scaled operations. Resource allocation is important for optimizing research operations and managing pricing effectively.

5. Allows seamless cross-department collaboration

By breaking down silos between different teams, work management tools enhance coordination among various team members, including physicians, data analysts, and regulatory teams. This leads to more effective clinical data management across departments and supports quality management initiatives.

6. Informs decision-making with real-time insights

Reporting and dashboard features provide access to up-to-date project data, facilitating quicker, data-driven decision-making in large-scale trials. These insights can be particularly valuable in case study analyses of trial performance and improving site management.

Asana: A powerful work management solution for clinical trial management

Combining Asana with clinical trial management software can significantly improve the efficiency of clinical research teams. By addressing key challenges in communication, project tracking, resource management, and collaboration, Asana helps research organizations scale their operations more effectively.

Manage complex dependencies across research studies

Track key milestones , study attributes, and metrics with custom fields

Visualize dependencies across teams like clinical research, biostatistics, and regulatory affairs with Gantt view

Add a single task to multiple projects to keep all teams aware of study progress

Report and share clinical trial progress

See progress across all in-flight studies with automatic progress roll-ups for goals and reporting dashboards

Update stakeholders with AI-generated status updates

Leverage permissions and controls to manage sensitive information and access levels

Streamline documentation and data collection

Make study documentation easy to reference with Google Workspace and Microsoft 365 integrations

Use proofing to collaborate on study reports before publishing

Transforming clinical research management with Asana

As the life science industry continues to evolve, the integration of advanced project management platforms with specialized clinical trial management software will be make-or-break in driving excellence in clinical research.

By leveraging these powerful software solutions, clinical research trials can improve their operational efficiency, increase regulatory compliance, and ultimately accelerate the development of life-saving treatments.

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Top 15 Clinical Research Companies: Leaders in Medical Innovation

What’s on this page:

In the healthcare industry, the number of contract research organizations in the US has reached 2,823 in 2023. This marks a subtle but significant increase of 0.9% compared to the previous year.

This increase signals a vital trend: the growing complexity of finding the best clinical research companies in a crowded field. These organizations aren’t just businesses; they’re important in advancing medicine and developing drugs and therapies.

With such an important task, choosing the right company becomes essential. In this guide, we’ve looked closely at many companies along with their strengths and weaknesses and made a list of the top clinical research organizations. 

By the end, you’ll know which company is the best fit for your needs.

Quick List of Top 15 Clinical Research Companies

Here is a quick overview of the best companies of clinical research:

• IQVIA: Best for data-driven insights and advanced analytics in healthcare research.
• ICON: Best for comprehensive clinical development services and therapeutic expertise.
• Parexel: Best for global biopharmaceutical services, emphasizing regulatory and clinical trial excellence.
• Syneos Health: Best for integrated biopharmaceutical solutions and clinical-commercial capabilities.
• PPD: Best for drug development services with innovative, technology-enhanced trial strategies.
• Labcorp: Best for comprehensive clinical testing and diagnostics services with global reach.
• Medpace: Best for expertise in clinical research and regulatory affairs for pharmaceutical companies.
• Charles River Laboratories: Best for preclinical research and development services, including animal testing and research models.
• PRA Health Sciences: Best for clinical trial expertise and integrated solutions for biopharmaceutical development.
• AdvanCell: Best for innovative cell and tissue-based research solutions for life science industries.
• Dynata: Best for data-driven insights and market research services for informed decision-making.
• Covance: Best for end-to-end drug development solutions, from preclinical to post-marketing.
• MedNet: Best for technology solutions and eClinical platforms for streamlined clinical trials.
• Fisher Clinical Services Inc: Best for global logistics and supply chain services for clinical trial materials.
• Worldwide Clinical Trials: Best for specialized CRO offering personalized clinical research solutions.

3 Best Clinical Research Organizations: Comparison Chart

Here’s a comparison table to highlight the key features and differences among the best companies of clinical research. This table aims to provide a quick overview of each company’s unique strengths and areas of expertise in the pharmaceutical and healthcare research sector.

3 Top Clinical Research Organization List For Advanced Medical Discoveries

Now, we’ll explore the top clinical research organizations (CROs) dedicated to advancing medical discoveries. Let’s jump into the details of these exceptional organizations.

IQVIA is a global leader in clinical research and healthcare data analytics. They play a crucial role in the medical field by providing comprehensive data, advanced analytics, and expert insights. This helps pharmaceutical and healthcare companies make smarter, more effective decisions. 

Why is IQVIA among the best? Their strength lies in their vast database and advanced technology, which enable them to analyze complex healthcare data efficiently. This leads to a better understanding of diseases, more effective treatments, and faster drug development. 

IQVIA’s work is essential because it speeds up the process of bringing new medicines to the market, ultimately benefiting patients worldwide. In short, IQVIA is a key catalyst in advancing global healthcare.

About IQVIA

• Founding Team: Dennis Gillings
• Founding Year: 1982
• Company Size:   86,000

Features of IQVIA

IQVIA, a prominent player in the life sciences sector, is dedicated to advancing healthcare through connected intelligence. Here are some key features of IQVIA in the world of clinical research:

Innovative Clinical Development

IQVIA is reimagining clinical development by intelligently connecting data, technology, and analytics. This approach leads to faster decision-making and reduced risk, enabling the delivery of life-changing therapies more quickly.

Efficient Payment Systems for Clinical Trials 

They have simplified the process of paying sites involved in clinical trials. IQVIA offers the capability to make payments within 30 days, even in challenging locations. This significantly reduces the administrative burden of managing clinical trial payments by up to 90%.

Decentralized Trials Expertise

The company has conducted over 500 studies in more than 75 countries, covering over 30 indications using decentralized trial methodologies. This demonstrates their capability in managing complex, multinational clinical trials.

Global Reach and Impact

With a presence in various regions, including Australia, New Zealand, the Middle East, and Africa, IQVIA’s global footprint allows it to drive healthcare innovations worldwide.

AI and Technology Integration

The company is at the forefront of integrating AI and other technologies in healthcare. Their Healthcare-grade AI promises precision, speed, scale, trust, and reliability, essential for advancing health and improving patient outcomes.

• Extensive, reliable healthcare data enhances market research quality.
• Utilizes AI and machine learning for advanced healthcare insights.
• Specialized focus yields a deep understanding of healthcare dynamics.
• Broad international presence enables diverse and large-scale studies.
• Offers advanced tools for insightful healthcare data analysis.
• Advanced tools can be challenging to use without training.
• Handling sensitive health data raises privacy and security issues.

Our Review of IQVIA

IQVIA, a prominent player in the healthcare and life sciences industry, presents a mixed bag of strengths and weaknesses. On the positive side, we appreciate IQVIA’s extensive expertise in data analytics and healthcare consulting. 

Their comprehensive research and analysis have undoubtedly driven valuable insights and innovations in the sector. Moreover, their global presence allows for diverse perspectives and access to critical healthcare data.

However, we must also acknowledge some shortcomings. IQVIA’s services can be prohibitively expensive for smaller organizations, limiting accessibility. Additionally, the sheer volume of data can sometimes lead to information overload, making it challenging to extract actionable insights.

ICON is a prominent company in the field of clinical research, playing a significant role in advancing medical science. They specialize in designing and conducting clinical trials for new medicines and treatments. 

The work of ICON is crucial because they help determine the safety and effectiveness of these potential medical breakthroughs. They are considered one of the best in clinical research due to their high standards of accuracy, reliability, and ethical practices. 

ICON’s expertise ensures that the clinical trials they manage are conducted efficiently and effectively, leading to faster approval of new treatments. This directly impacts patient care, as it allows quicker access to new, potentially life-saving medicines. 

In essence, ICON’s contribution is vital in driving forward medical innovations.

• Founding Team: John Climax and Ronan Lambe
• Founding Year: 1990
• Company Size: 41,160

Features of ICON

Here are some of the key features of ICON in clinical research:

Diverse Clinical and Scientific Operations

ICON offers a wide range of clinical and scientific operations services, ensuring comprehensive support for various aspects of clinical trials. This includes everything from study design to execution and data analysis.

Decentralized Clinical Trial Solutions

They provide end-to-end services, operational models, and technology to deliver customized solutions for decentralized clinical trials. This approach is increasingly important in today’s clinical research landscape, offering flexibility and efficiency.

Specialized Therapeutic Areas

ICON has expertise across multiple therapeutic areas including cardiovascular, central nervous system, endocrine & metabolic disorders, infectious diseases, internal medicine & immunology, oncology, and more. This broad expertise allows them to handle a wide range of clinical research projects.

Innovative Solutions for Biotech

ICON provides full-service outsourcing and flexible support customized to the specific needs of biotech companies. This includes due diligence and asset valuation, which are critical for biotech firms navigating the complex landscape of drug development.

Advanced Medical Imaging Solutions

Their expert medical imaging solutions support all stages of clinical research, improving decision-making, increasing efficiency, and reducing trial costs.

• Decades of expertise ensure high-quality clinical research.
• Offers wide-reaching capabilities for multi-regional clinical studies.
• Deep understanding of global regulations enhances compliance and efficiency.
• Invests in new technologies for more efficient trial processes.
• Broad range of specialties contributes to comprehensive service offerings.
• Managing multi-regional trials can lead to logistical challenges.
• Rapid growth may strain resources and affect service quality.

Our Review of ICON

When we researched ICON, we found both commendable aspects and areas for improvement. On the positive side, we appreciate their commitment to clinical research and their global presence, which allows for diverse study options. Their experienced team and advanced technology contribute to reliable data collection and analysis.

However, there are some drawbacks to consider. We have noticed occasional delays in project timelines, which can be frustrating. Additionally, the cost of their services tends to be on the higher side, making it a potential barrier for smaller research endeavors.

Parexel is a globally recognized company in clinical research, known for its important role in developing new medical treatments. They are one of the biggest clinical research organizations. Parexel conducts clinical trials, crucial steps in testing the safety and effectiveness of new drugs. 

The work of Parexel is essential because it bridges the gap between medical research and the availability of new treatments to patients. One of the reasons they stand out as one of the best in this field is their rigorous approach to research. 

Their commitment to quality and their global network also enables diverse and large-scale studies, setting them apart from others in the field. These strengths allow Parexel to deliver reliable and valuable data, accelerating the process of bringing new, effective medicines to the market. 

Simply put, Parexel is a key player in transforming medical research into real-world health solutions.

About Parexel

• Founding Team: Josef von Rickenbach and Anne B. Sayigh
• Company Size: 18,900

Features of Parexel

Parexel, a global biopharmaceutical services organization, offers a range of features in clinical research. Here are some key aspects of their approach:

Patient-Centric Approach

Parexel emphasizes a patient-first strategy in their clinical trials. This approach results in deeper and more relevant insights for trial design and execution. This ensures that the trials are more aligned with patient needs and experiences.

Innovative Trial Designs

Parexel employs innovative trial designs to optimize trials for maximum impact. This includes advanced modeling and simulation to predict drug effects ahead of time, which can save time, money, and resources.

Regulatory Compliance and Market Access

Parexel designs studies and endpoints with market access in mind, ensuring that they satisfy global regulations. This approach helps in getting treatments to patients safely and quickly.

Patient Advocacy and Engagement

The company includes patient advocates in their council, using their experiences to improve trial designs. This inclusion demonstrates their commitment to understanding and incorporating patient perspectives in clinical research.

Focus on Speed and Precision

Parexel aims to design neuroscience trials with speed and precision, utilizing the right experts and specializations. This focus is crucial in delivering effective treatments on time.

• Provides advanced technology and analytics for efficient data management.
• Extensive network provides global insights with regional knowledge.
• Expertise in navigating complex regulatory environments worldwide.
• Broad experience across various therapeutic areas ensures versatile solutions.
• Focuses on patient engagement for more effective trial outcomes.
• Rapid expansion can lead to challenges in resource management.
• Concentration in specific areas could pose risks in market shifts.

Our Review of Parexel

Parexel is a notable player in the field of clinical research and pharmaceutical services. We’ve thoroughly analyzed their offerings and found both strengths and areas that need improvement.

On the positive side, Parexel excels in its commitment to innovation and technology. We appreciate their continuous efforts to simplify clinical trials and drug development processes, making them more efficient.

However, we also noticed some downsides. Communication with clients could be more transparent, with clearer updates on project progress. Additionally, there’s room for improvement in terms of ensuring consistency in service quality across different projects.

Other 12 Companies of Clinical Research

In the world of clinical research, beyond the well-known names, there are 12 other companies making significant contributions. Let’s explore their vital role in advancing healthcare.

1. Syneos Health

Syneos Health helps develop medicines by managing clinical trials for new drugs. They’re essential because they ensure medicines are safe and effective. Syneos Health stands out in clinical research for its comprehensive services and global reach, making drug development smoother and faster.

About Syneos Health

• Founding Team: Colin Shannon
• Founding Year: 1980
• Company Size: 28,000

PPD is a group that tests new drugs to see if they’re good and safe. This is crucial for getting new treatments to people. They stand out for their thorough research and global reach.

• Founding Team: Fred Eshelman 
• Founding Year: 1985
• Company Size: 40,000+3

Labcorp does important tests and research for health. They’re needed because they help find out if new treatments are good. They’re among the best for their big labs and fast results.

About Labcorp

• Founding Team: Matthew Benger
• Founding Year: 1978
• Company Size: 75,5000

Medpace focuses on making sure new health treatments are safe. This is key for better medicine. They’re a top choice because of their focus on quality and detail in research.

About Medpace

• Founding Team: August Troendle
• Founding Year: 1992
• Company Size: 5,400

5. Charles River Laboratories

Charles River Laboratories tests drugs and does research to help pets and people stay healthy. They’re essential for safe, new treatments. Their expertise makes them a leader in the field.

About Charles River Laboratories

• Founding Team: Henry Foster
• Founding Year: 1947
• Company Size: 21,400

6. PRA Health Science

PRA Health Science works on finding out if new medicines are safe. This helps everyone get better treatments. They’re known for their excellent research and care in studies.

About PRA Health Science

• Founding Year: 1976
• Company Size: 17,000+

7. AdvanCell

AdvanCell specializes in new treatments, checking if they’re safe and working. Their work is vital for progress in medicine. They’re recognized for their innovation in research.

About AdvanCell

• Founding Team: Andrew Adamovich

Dynata gathers data for health studies. They’re needed for understanding what works in healthcare. They’re a top name for their accurate and wide-reaching data collection.

About Dynata

• Founding Team: Mike Petrullo
• Founding Year: 1940
• Company Size: 5000-10000

Covance helps with drug tests and research to fight diseases. Their role is key for new treatments. They’re celebrated for their comprehensive services and global impact.

About Covance

• Founding Team: Fred Cummings
• Founding Year: 1981
• Company Size: 50,000

MedNet provides software for managing clinical trials. This helps in making research easier and faster. They’re among the best for their tech solutions in research.

About MedNet

• Founding Team: John “Rob” Robertson
• Founding Year: 1996
• Company Size: 51-200

11. Fisher Clinical Services Inc.

Fisher Clinical Services Inc. manages the logistics of clinical trials, ensuring that treatments are tested efficiently. Their work is crucial for the progress of medicine, and they are renowned for their reliability and global network.

About Fisher Clinical Services Inc.

• Founding Team: John Pickering
• Founding Year: 1989

12. Worldwide Clinical Trials

Worldwide Clinical Trials conducts essential research to evaluate new medical treatments. Their work is critical for advancing healthcare. They are distinguished by their global expertise and commitment to innovation in clinical research.

About Worldwide Clinical Trials

• Founding Team: Neal Cutler
• Founding Year: 1986
• Company Size: 3,147

What To Consider When Choosing the Best Clinical Research Companies?

Choosing the right clinical research company (CRC) is crucial for the success of any clinical trial. Here’s a detailed guide on what to consider:

Expertise and Specialization

Always ensure the CRC has expertise in your specific therapeutic area. Companies with experience in similar drug trials or medical devices can better navigate the complexities of your project.

Regulatory Compliance

The CRC must adhere to regulatory guidelines like FDA (US) , EMA (Europe), and others. Check their track record in meeting these standards to avoid compliance issues.

Reputation and Track Record

You should research the company’s history. Look for testimonials, case studies, and reviews from past clients. A company with a strong reputation is likely to deliver quality results.

Project Management Capabilities

Effective project management is key. Assess their ability to manage timelines, budgets, and communication. A CRC that provides transparent, regular updates is preferable.

Patient Recruitment Strategies

Patient recruitment can be challenging. Evaluate their strategies for participant recruitment and retention. Consider their demographic reach and methods for ensuring a diverse participant pool.

Data Management and Analysis

The CRC should have strong systems for data collection, management, and analysis. Ask about their use of Electronic Data Capture (EDC) systems and how they handle data security and confidentiality.

Cost and Financial Terms

Get a clear understanding of the cost structure. Consider the value for money rather than just the lowest cost. Ensure there are no hidden fees and clarify what is included in the quoted price.

How Heartbeat AI Can Help You Get the Best List of Clinical Research Organizations?

Heartbeat AI, with its advanced features, can significantly assist in identifying the best list of clinical research organizations (CROs). Here’s how its various features contribute to this process:

Data Analysis and Processing

Heartbeat AI excels in analyzing vast amounts of data. When it comes to selecting CROs, it can process and analyze information from numerous sources, including past performance records, clinical trial reports, and regulatory compliance data. This thorough analysis helps in identifying CROs with a proven track record of success and reliability.

Machine Learning Algorithms

These algorithms enable Heartbeat AI to learn from historical data and improve its recommendations over time. By understanding trends and patterns in the successful execution of clinical trials, it can better predict which CROs are likely to meet your specific needs.

Predictive Analytics

Heartbeat AI uses predictive models to forecast future trends and outcomes based on historical data. This can be invaluable in predicting the success rate of CROs in upcoming projects, thus aiding in making more informed choices.

Customization and Personalization

The AI can be customized to your specific requirements. If you’re focusing on a specific therapeutic area or clinical trial phase, Heartbeat AI can prioritize specialized CROs in these fields.

Real-time Data Updates

The healthcare and pharmaceutical landscapes are constantly changing. Heartbeat AI’s ability to integrate and analyze real-time data ensures that the recommendations are based on the most current information available.

Integration with External Databases

Heartbeat AI can integrate with various external databases and platforms. This enables it to pull in comprehensive information about CROs from diverse sources, enhancing the accuracy of its recommendations.

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Summing up, we’ve explored the best clinical research companies, diving into their features, strengths, weaknesses, and more. Clinical research is vital in healthcare; it’s key for advancing medical knowledge and developing new treatments. 

With this guide, you’re equipped to find the right clinical research company that meets your specific needs. Whether it’s for innovative therapies, drug development, or medical advancements, choosing the right partner is crucial. This guide serves as a valuable resource to help you make an informed decision in the complex world of clinical research.

Frequently Asked Question

What services do companies of clinical research offer.

Clinical research organizations offer a wide range of services, including protocol development, patient recruitment, data collection and analysis, regulatory compliance, and more.

What is the role of a clinical research coordinator?

A clinical research coordinator is responsible for managing various aspects of a clinical trial, including patient recruitment, data collection, and ensuring compliance with protocols.

What is informed consent in clinical research?

Informed consent is the process by which participants in a clinical trial are fully informed about the study’s purpose, risks, and benefits. They voluntarily agree to participate based on this information.

Clario accelerates your clinical trial from initiation to implementation. LEARN MORE →

Are paper PROs cost-effective?

Patient-reported outcomes (pros) can differentiate your oncology drug. find out why paper pros are rarely the best — or cheapest —​ option compared to electronic pros. , elevate efficacy, ensure safety and improve patient quality of life in your oncology trials.

With nearly 2,000 imaging oncology studies, Clario brings proven response criteria expertise complemented by unmatched experience.

Clario’s commitment to patient safety is at the core of our oncology drug development support.

Quality of life

Clario prioritizes the impact of treatments on patients’ mental health and daily functionality, ensuring their well-being remains paramount.

Oncology Clinical Trial solutions

Watch this video to learn more about our collaborative approach to partnerships in oncology trials.

ABOUT CLARIO

Transforming lives with the most comprehensive endpoint technologies and solutions for clinical trial management., scientific expertise.

Our team of hundreds of clinical trial management experts ensures that therapeutic area and endpoint science informs all aspects of our evidence generation technologies. Combined with our extensive global regulatory experience, we provide certainty in the reliability and precision of clinical evidence across our technology portfolio, enabling site-based, hybrid and decentralized clinical trials.

Global scale

Thousands of customer operations professionals deliver unrivaled global deployment capability. With trials in over 100 countries, translations in over 100 languages and experience built from the delivery of over 26,000 trials, we have the regulatory and operational expertise to execute globally.

Broadest endpoint services and technology platform

Our uniquely engineered and validated clinical trial management software, connected devices and artificial intelligence solutions across Cardiac Safety , eCOA , Medical Imaging , Precision Motion and Respiratory provide the broadest evidence generation platform in the industry.

Delivering decentralized trials with reliability and precision

Only Clario has the science, innovative technologies, regulatory expertise, and global operational infrastructure to power decentralized, hybrid and site-based clinical trials — with reliability and precision. Clario offers sites and sponsors more clinical trial options, empowers patient choice, and provides the means to create diversity within clinical trials, improving health equity.

CLARIO SOLUTIONS

Our solutions simplify the trial process.

At Clario we are simplifying the clinical trial process for sponsors, sites, and CROs. Our platform integrates the broadest endpoint technologies, fused with deep scientific expertise and global scale. With 24/7 partner and patient support, along with training and instructions integrated into our devices, our technology and clinical trial management and solutions drive successful adoption, compliance, and retention.

Why Clario?

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We are always looking for the best talent to help us transform the lives of patients.

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If you are looking to generate the richest evidence for your clinical trial, contact us.

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Proven, faster DCT solutions

IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Our hybrid and fully virtual solutions have been used more than any others.

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Clinical Research & Development Solutions

Harness the power to transform clinical development.

Reimagine clinical development by intelligently connecting data, technology and analytics to optimize your trials. The result? Faster decision making, innovation with reduced risk and driving trials without compromise so you can deliver life-changing therapies faster.

IQVIA Flex Outsourcing Solutions

Optimize a single protocol or your entire portfolio to reduce protocol amendments and avoid costly delays using our deep trial expertise, expansive data and advanced analytics.

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IQVIA Decentralized Trials

Scalable and proven, decentralized trial solutions engage the right patients wherever they are. Our hybrid and fully virtual models have been fine-tuned in over 500 decentralized trials, across 30+ therapy areas, in more than 75 countries.

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Our targeted patient identification approach uses AI and machine learning to identify more qualified and engaged patients with greater precision. Deep partnerships with study sites make for seamless integration of teams, tools and data and lessen site and patient burden.

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Accelerate trial outcomes by streamlining the selection of connected devices that collect and analyze data. Our unbiased recommendations support multiple endpoints, and our logistics and data services make it easier for patients to participate and for sites to collect data.

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Assess your protocol against real world evidence using advanced analytics, and reduce the risk of costly amendments.

Access central labs around the globe through Q² Solutions, a wholly owned subsidiary of IQVIA.

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Clinical development solutions built for biotech success.

From early phase through global registrational studies, we deliver with built-in flexibility.

New thinking in clinical development

Asian market trends in r&d 2024.

Discover the R&D trends and prime opportunities in Asia Pacific, a prominent hub for the biopharma industry.

Rethinking Clinical Trial Country Prioritization

Enabling agility through global diversification

Leveraging Real World Evidence to Support Oncology Targeted Therapies

How we overcome the lagging of biomarker testing

Global Oncology Trends 2024: Outlook to 2028

Annual trend report from the IQVIA Institute for Human Data Science

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Data on the importance of generic medicines and their role in treating chronic health conditions and providing savings to the U.S. healthcare system.

Strengthening Pathways for Cell and Gene Therapies: Current State and Future Scenarios

This report from the IQVIA Institute reflects on the current state of the end-to-end environment for cell and gene therapies

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Outlook for 2024: 7 key indicators of progress in the life sciences sector.

What will be “good news” for the life sciences sector in 2024?

Succeeding with Innovation: The State of Radioligand Therapy Readiness in Europe

Trends in global adult vaccination: a view from five global cities, trends in global adult vaccination.

Impact of COVID-19

Scaling-up Inclusive Healthcare in Low- and Middle-Income Countries 2

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RealTime eClinical Solutions

Our dedicated team of realtime experts will help you implement the solutions that will enable your business to run better and perform higher..

Leader in cloud-based software solutions for the clinical research industry

For over a decade, RealTime eClinical Solutions, formerly RealTime Software Solutions, has led the way in cloud-based software solutions for the clinical research industry. With the recent acquisitions of Complion eRegulatory / eISF and Devana Solutions for study start-up, pipeline management, and business intelligence, RealTime is at the forefront  of addressing industry challenges with product solutions that streamline the entire clinical research experience .  

RealTime is the all-in-one platform to source, stand up and execute modern-day clinical trials. We use technology to connect people and data more easily than ever, helping sites, CROs, and sponsors manage research and business, together. Now you can deliver more trials, more quickly, and more safely – all at scale.  

Why are RealTime systems so easy to use and why do they work so well for the businesses that utilize them?

As industry practitioners, we know it’s not just about getting more software – it’s about getting the most from the software you have . We are continuously listening to our customers and evolving industry needs to deliver impactful solutions that strengthen compliance, improve data integrity, streamline oversight, and reduce administrative burdens on staff. And with RealTime’s dedicated focus on exceptional customer service, clients can trust that our team will provide guidance and resources to get the most out of the eClinical solutions, from implementation, data migration, template building, and beyond.

As former site owners, RealTime is further distinguished by its exceptional leadership, comprising seasoned industry professionals with firsthand experience in clinical trial site management. Supported by our team of world-class software developers, experienced and excel in building powerful, yet user-friendly enterprise software solutions, we ensure our technology meets the rigorous demands of the clinical research industry. 

Looking to streamline your clinical trial operations with a solution that is as unique as your needs? RealTime eClinical Solutions offers extensive features that can be tailored individually or combined into an integrated system, catering precisely to the unique requirements of each client.

To reshape the global clinical research industry with innovative solutions that help advance medicine and save lives.

Our mission, the realtime team strives everyday for the complete success of our customers accomplished through listening, learning, innovating, and with an inspired passion for more efficient clinical research processes., realtime software solutions, llc.

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RealTime eClinical Solutions is a leading, enterprise-grade technology provider facilitating global clinical trials with a comprehensive eClinical platform. Purpose-built for clinical research sites, site networks, academic medical centers, sponsors, and CROs, the platform goes beyond traditional CTMS to empower research and business workflows for modern-day clinical trials.

Privacy Overview

Clinical Trial Software Development Process: Optimizing Outcomes

Clinical trials are at the heart of medical research, responsible for the development of new treatments and therapies that save lives. Traditionally, managing these trials involved cumbersome paperwork, manual data entry, and lengthy processes susceptible to human error. As technology advanced, the industry witnessed a seismic shift from paper-based methods to sophisticated digital solutions designed to enhance efficiency, accuracy, and compliance. Understanding the clinical trial software development process is crucial for ensuring these advancements are fully leveraged.

Imagine navigating the complexities of clinical trials with a streamlined, efficient system that not only reduces errors but also accelerates the entire process. This transformation is made possible through the meticulous development and deployment of clinical trial software. 

Let’s delve into the key elements that make this technology a game-changer in the world of medical research and explore how embracing it can propel your organization toward greater success.

Top Takeaways:

• Integrating clinical trial software with existing healthcare systems can be complex due to data silos and compatibility issues, requiring extensive customization and a unified data management approach.
• Clinical trial software streamlines processes, reducing errors and accelerating timelines, which is crucial for medical research advancement.
• Ensuring compliance with diverse and evolving regulations like FDA guidelines and GDPR adds a layer of complexity, necessitating built-in compliance features and continuous updates to avoid costly penalties

Table of Contents:

Why is Clinical Trial Management Software Important?

Benefits and downsides of clinical trial software, the clinical trial software development dilemma, essential components and types of clinical trial software, factors to consider when choosing the best clinical trial management software, decoding the clinical trial software development process, integrating clinical trial software with existing healthcare systems, ensuring data security and regulatory compliance in clinical trial software, measuring roi: kpis for clinical trial software implementation, the cost of clinical trial software, real-world use cases of clinical trial management software, emerging trends in clinical trial management software, how topflight addresses clinical trial software development challenges.

Clinical trial management software is pivotal for several reasons:

• Efficiency and Speed : By automating many trial processes, such as patient recruitment, data collection, and monitoring, clinical trial software significantly reduces the time required to conduct studies.
• Data Integrity and Compliance : Ensuring that data is accurate and adheres to regulatory standards is crucial. Software solutions minimize human errors and enhance data integrity.
• Cost-Effectiveness : While the initial investment might be significant, the long-term savings due to increased efficiency, reduced need for manual labor, and fewer errors make clinical trial software a cost-effective solution.
• Scalability : As trials become more complex, involving multiple sites and diverse patient populations, scalable software solutions can manage large volumes of data and support extensive collaboration across different geographical locations.

Key Statistics and Market Insights Shaping Clinical Trial Management Software

To appreciate the impact of clinical trial software, consider some compelling statistics:

• The global clinical trial management system (CTMS) market is projected to reach $4.7 billion by 2030 from approximately $1.85 billion in 2023.
• Anticipated to surpass $1.5 billion by 2030 in the US, driven by high clinical trial activity and supportive government regulations.

The Clinical Trial Management System (CTMS) market is experiencing significant growth, driven by advancements in healthcare IT and the increasing adoption of cloud-based solutions.

Key Drivers

• Technological Advancements : Rapid growth of healthcare IT and cloud-based solutions are major drivers. Cloud-based CTMS solutions offer scalability, flexibility, and cost-effectiveness, making them highly attractive to pharmaceutical companies, CROs, and academic institutions.
• Decentralized Clinical Trials (DCTs) : The preference for decentralized trials is increasing. Companies provide solutions tailored for virtual trials, including electronic patient-reported outcomes (ePRO), remote monitoring, and electronic consent (eConsent).
• Government Initiatives : Programs such as the U.S. Advanced Research Projects Agency for Health (ARPA-H) enhance the ability to conduct clinical trials rapidly and safely.

Market Segmentation

• Components : Divided into software and services, with the software segment leading the market due to high utilization.
• Product Types : Enterprise-based CTMS holds a 74.35% revenue share, offering comprehensive solutions for centralized recruitment and resource management.
• Delivery Modes : Web-based solutions dominate, accounting for over 59% of the market share in 2021 due to their versatility.
• End-Users : Pharmaceutical and biopharmaceutical companies are expected to grow significantly, registering a healthy growth rate of 10.6% over the forecast period.

In the realm of clinical research, efficient data management and streamlined processes are paramount. Clinical trial software plays a critical role in achieving these goals but, like any technology, it comes with its own set of benefits and challenges.

Benefits of Clinical Trial Software

Enhanced data management and accuracy.

Clinical trial software provides robust solutions for managing vast amounts of clinical trial data, ensuring that data is accurately recorded, stored, and easily retrievable. This enhances data integrity and reduces the risk of errors associated with manual data entry.

Improved Efficiency and Speed

Automating many aspects of clinical trials—such as patient recruitment, scheduling, and monitoring—allows for more efficient processes. This not only accelerates the pace of trials but also frees up valuable time for researchers to focus on critical tasks.

Compliance and Regulatory Adherence

Maintaining compliance with regulatory standards is crucial. Clinical trial software often includes features designed to ensure adherence to regulations such as GCP (Good Clinical Practice) and FDA guidelines. This minimizes the risk of non-compliance and ensures that trials meet all required standards.

Scalability and Flexibility

Modern clinical trial software solutions are scalable, allowing organizations to manage multiple trials simultaneously across various locations. This flexibility supports the growth and expansion of clinical research initiatives without significant additional investment.

Enhanced Communication and Collaboration

These platforms facilitate better communication and collaboration among research teams, sponsors, and other stakeholders. Features such as sharing data in real time and centralized documentation improve transparency and coordination throughout the clinical trial process.

These advantages illustrate the significant benefits of integrated healthcare systems , streamlining processes and enhancing overall clinical trial efficiency.

Downsides of Clinical Trial Software

While clinical trial software offers numerous benefits, there are inherent downsides that can impact its overall efficacy and user experience.

Initial Implementation Costs

Deploying clinical trial software requires a significant upfront investment. This encompasses the cost of the software itself, hardware upgrades, staff training, and integration with existing systems. The financial burden can be substantial, particularly for smaller organizations with limited budgets.

Complexity of Integration

Integrating clinical trial software with existing healthcare IT infrastructure can be a complex and time-consuming process. Compatibility issues may necessitate extensive customization and additional resources to ensure seamless operation, potentially delaying the implementation timeline.

Learning Curve for Users

Adopting new clinical trial software involves a learning curve for all users. Ensuring that researchers, coordinators, and other stakeholders are adequately trained and comfortable with the new system can be challenging. This period of adjustment can lead to temporary inefficiencies and frustration among staff.

Data Security Risks

While clinical trial software improves data management, it also introduces risks related to data security. Protecting sensitive clinical trial data from breaches and unauthorized access requires robust security measures and continuous monitoring. Any lapse in security protocols can result in significant legal and reputational repercussions.

Dependence on Vendors

Reliance on third-party vendors for clinical trial software can create dependency issues. Organizations may face challenges related to vendor stability, ongoing support, and the potential for vendor lock-in, which can limit flexibility and control over the software in the long term.

In the dynamic landscape of clinical research, CIOs and VPs of Technology face a myriad of challenges when implementing clinical trial software. Let’s explore some of the critical issues that can significantly impact the development and deployment process while also identifying opportunities for improvement.

Data Silos and Integration Challenges

One of the foremost dilemmas is the existence of data silos within research sites. When patient data is fragmented across various systems, it hinders seamless communication and data sharing. This fragmentation can lead to inefficiencies and errors, ultimately compromising the integrity of clinical studies.

Solution: Unified Data Management

To combat this, focusing on integrating clinical trial software with existing healthcare IT infrastructure is essential. A unified data management system ensures all relevant data is accessible from a single platform, improving collaboration and data accuracy.

Regulatory Compliance

Navigating the complex web of regulatory requirements is another significant hurdle. Ensuring that clinical trial software complies with local and international standards, such as FDA guidelines, GDPR, and HIPAA, can be daunting. Non-compliance can lead to costly penalties and delays in the approval process.

Solution: Built-in Compliance Features

Incorporating built-in compliance features within the software can help automate adherence to regulatory standards. Regular updates and audits ensure compliance of the software with evolving regulations.

Scalability and Adaptability

As clinical trials grow in scale and complexity, the software must adapt accordingly. Ensuring the software can handle increasing volumes of patient data, multiple research sites, and diverse clinical studies is crucial for long-term success.

Solution: Modular Design

Adopting a modular design allows for scalable solutions that can be tailored to specific needs. This flexibility ensures that the software can evolve with the growing demands of clinical research.

Cost and Resource Management

Budget constraints are a common challenge. The initial investment in clinical trial software, along with ongoing maintenance and training costs, can strain financial resources. Balancing this expenditure with the potential benefits requires careful planning and justification.

Solution: Clear ROI Metrics

Implementing clear ROI metrics helps justify the investment. By demonstrating how the software can lead to cost reductions, improved efficiency, and better patient outcomes, decision-makers can make informed budgetary decisions.

User Adoption and Training

Introducing new software often comes with a learning curve. Ensuring that all stakeholders, from researchers to administrative staff, are adequately trained and comfortable with the new system can be time-consuming and resource-intensive.

Solution: Comprehensive Training Programs

Developing comprehensive training programs that include hands-on sessions, user manuals, and continuous support can ease the transition. Encouraging feedback and iterative improvements based on user experience enhances adoption rates.

Time-to-Market Pressure

Speed is critical in clinical studies. Delays in the software development process can push back trial timelines, affecting market entry and competitive advantage.

Solution: Agile Development Methodologies

Utilizing agile development methodologies can accelerate the development process. By breaking down the project into smaller, manageable phases, teams can adapt to changes quickly and deliver functional software more rapidly.

Quality and Reliability

Ensuring that the clinical trial software is robust and reliable is non-negotiable. Any glitches or downtime can disrupt clinical studies and compromise data integrity.

Solution: Rigorous Testing Protocols

Implementing rigorous testing protocols, including automated and manual testing, ensures that the software meets high-quality standards. Continuous monitoring and regular updates help maintain reliability.

Vendor Management

Selecting the right vendor is crucial, as it impacts not only the implementation but also long-term support and upgrades. Dependency on a third-party vendor can pose risks if the vendor’s stability or service quality declines.

Solution: Strategic Partnerships

Forming strategic partnerships with reputable vendors who have a proven track record in clinical trial software can mitigate these risks. Clear SLAs (Service Level Agreements) and regular performance reviews ensure consistent support.

Innovation and Staying Current

The rapid pace of technological advancements means that clinical trial software must continually evolve to stay relevant. Keeping up with new features, technologies, and methodologies can be overwhelming.

Solution: Continuous Innovation Framework

Adopting a framework for continuous innovation ensures that the software remains cutting-edge. Regularly updating the software with new features and incorporating feedback from end-users keeps the technology aligned with industry trends.

Change Management

Implementing new software necessitates change management strategies to address resistance and ensure smooth transition. Effective communication and leadership are key to guiding teams through the transformation.

Solution: Proactive Change Management

Proactively managing change through clear communication, involving key stakeholders in decision-making, and addressing concerns early on can facilitate a smoother implementation process.

Understanding the core components and types of software is crucial for anyone involved in clinical trial software development. By breaking down each module, clinical CIOs and VPs of Technology can better grasp what features are crucial for improving clinical trial operations, ensuring high data quality, and streamlining document management.

Electronic Data Capture (EDC) Systems

EDC systems are pivotal for capturing and managing clinical data efficiently. These systems help ensure data integrity and compliance.

• Real-time data entry and validation
• Remote data access for monitoring and analysis
• Audit trails for regulatory compliance
• Customized forms and data fields
• Integration with other clinical trial systems

Clinical Trial Management System (CTMS)

CTMS centralizes trial management activities, enhancing operational efficiency and oversight.

• Study planning and tracking
• Site management and monitoring
• Budgeting and financial tracking
• Patient recruitment and enrollment management
• Reporting and analytics

Randomization and Trial Supply Management (RTSM)

RTSM solutions ensure the proper allocation of treatments and management of trial supplies.

• Randomization schemes and algorithms
• Inventory management and tracking
• Drug supply chain management
• Compliance with blinding requirements
• Real-time inventory updates

Document Management Systems (DMS)

DMS provides a secure platform for managing all trial-related documents, ensuring accessibility and compliance.

• Centralized document repository
• Version control and document tracking
• Secure access and permissions
• Document workflow automation
• Regulatory submission management

Clinical Metadata Repositories (CMDR)

Manages metadata associated with clinical trials, ensuring consistency and standardization of data across different studies.

Safety Management Systems

Safety management systems focus on the reporting and tracking of adverse events to ensure patient safety.

• Adverse event tracking and reporting
• Safety data integration
• Compliance with safety regulations
• Signal detection and risk management
• Automated safety notifications

eConsent Platforms

eConsent platforms digitize the consent process, improving participant understanding and compliance.

• Interactive consent forms
• Multi-language support
• Real-time consent tracking
• Integration with EDC and CTMS
• Compliance with regulatory requirements

Understanding these components can empower decision-makers to select and implement the right clinical trial software, optimizing clinical trial operations and ensuring robust data quality. And leveraging advanced features in your software can help you to grow a medical practice by enhancing operational efficiency and patient satisfaction.

Selecting the right clinical trial management software can significantly impact trial efficiency, data integrity, and patient care. Here are some key factors to consider:

• Centralized repository for all trial-related data
• Easy access and retrieval of trial documents
• Robust electronic data capture (EDC) systems
• Automated data validation checks

To ensure seamless data flow, it’s crucial to thoughtfully choose an EHR system that aligns with your clinical trial software requirements.

• Patient recruitment and retention tools
• User-friendly patient portals and mobile apps
• Efficient handling of clinical metadata
• Integration with other clinical systems
• Ability to handle multiple trials and large datasets
• Customizable features to meet specific trial needs
• Adherence to regulatory standards (e.g., FDA, GDPR)
• Strong security measures to protect sensitive data
• Reliable customer support and training services
• Proven track record in the life sciences industry

Choosing the best clinical trial management software involves evaluating these factors to ensure it meets your organization’s needs, enhances trial efficiency, and supports high-quality patient care.

Navigating the clinical trial software development process can be a complex journey, especially for clinical CIOs and VPs of Technology. This section breaks down each phase to provide a clear roadmap for successfully developing robust and compliant clinical trial software.

Step 1: Planning

Effective planning lays the foundation for a successful project. It involves:

• Needs Assessment: Identifying specific requirements and goals.
• Stakeholder Engagement: Involving all relevant parties from the outset.
• Feasibility Study: Evaluating technical and financial viability.
• Project Charter: Documenting scope, timelines, and resources.

Step 2: Design

The design phase focuses on creating a blueprint for the software solution.

• User Requirements Specification (URS): Detailing user needs and expectations.
• System Design Specification (SDS): Outlining the architecture and components.
• Wireframing and Prototyping: Creating visual representations of the software.
• Usability Testing: Ensuring the design meets user requirements and is intuitive.

Step 3: Development

During development, the actual coding and construction of the software take place.

• Agile Methodologies: Employing iterative development cycles for flexibility.
• Modular Coding: Building independent, reusable modules.
• Integration: Ensuring compatibility with existing systems and workflows.
• Continuous Testing: Implementing unit tests and integration tests throughout development.

Ensure that you partner with a reliable healthcare app developer that understands the intricacies of clinical trials and can seamlessly integrate your software with existing systems and workflows.

Step 4: Testing

Comprehensive testing is crucial to ensure software reliability and compliance.

• Functional Testing: Verifying that all features work as intended.
• Performance Testing: Assessing the software’s responsiveness and stability.
• Security Testing: Ensuring data protection and regulatory compliance.
• User Acceptance Testing (UAT): Confirming the software meets end-user needs.

Step 5: Deployment

Deployment involves rolling out the software to the live environment.

• Pilot Launch: Initiating a small-scale launch to identify potential issues.
• Full Rollout: Deploying the software across all intended sites.
• Training and Support: Providing comprehensive training and ongoing support to users.

Step 6: Maintenance and Updates

Post-deployment, continuous maintenance and updates are necessary to ensure long-term success.

• Monitoring and Feedback: Collecting user feedback and monitoring performance.
• Bug Fixes and Enhancements: Addressing issues and adding new features.
• Compliance Updates: Keeping the software aligned with evolving regulations.

Understanding the medical trial software development process helps you navigate each phase effectively, from initial planning through to maintenance. By following this structured approach, organizations can ensure they develop robust, compliant, and user-friendly solutions.

As you plan the development stages, you might also explore how to create a telehealth app to enhance patient engagement and remote monitoring capabilities.

Integrating new clinical trial software with existing healthcare IT infrastructure is a critical challenge that CIOs and VPs of Technology must address to ensure seamless operations and data management. The key integration strategies include:

• API Utilization : Leverage APIs (Application Programming Interfaces) to facilitate smooth data exchange between your new clinical trial software and existing systems. This enables real-time data sharing and reduces manual entry errors.
• Data Standardization : Ensure that clinical trial data formats are standardized across all platforms. Consistent data structures make it easier to integrate and analyze information from various sources, enhancing the efficiency of your health trial software development.
• Interoperability Testing : Conduct comprehensive interoperability tests to identify and resolve potential conflicts between the new software and existing systems. This proactive approach minimizes downtime and ensures a smoother implementation process. When considering the interoperability of your clinical trial software, don’t overlook the potential benefits of EHR PointClickCare integration , which can streamline patient data management.
• User Training : Provide training for staff to familiarize them with integrated workflows. Clear understanding of how the new system interacts with existing tools enhances productivity and reduces resistance to change.
• Vendor Collaboration : Work closely with software vendors to troubleshoot integration issues and customize solutions according to your organization’s unique needs. Strong vendor support can significantly streamline the integration process.

Data security and regulatory compliance are paramount concerns for healthcare executives when implementing a new CTMS solution. Failure to address these issues can lead to significant legal and financial repercussions.

Encryption Standards

Implement robust encryption standards, such as AES-256, to protect sensitive clinical trial data both at rest and in transit. This ensures that patient information remains secure from unauthorized access.

Access Controls

Utilize role-based access controls to limit data access based on user roles and responsibilities. This minimizes the risk of data breaches and ensures that only authorized personnel can view or modify sensitive information.

Compliance Audits

Regularly conduct compliance audits to ensure that your CTMS solution meets industry regulations such as HIPAA , GDPR, and FDA guidelines. Audits help identify potential compliance gaps and provide an opportunity for corrective actions.

Incorporating EHR in medical billing within your clinical trial software can significantly improve financial tracking and compliance.

Incident Response Plan

Develop a comprehensive incident response plan to quickly address data breaches or security incidents. A well-defined plan ensures that your organization can respond promptly and effectively to mitigate any damage.

Continuous Monitoring

Implement continuous monitoring tools to track system activity and detect unusual behavior patterns. Real-time alerts enable immediate intervention, reducing the risk of significant data security breaches.

By addressing these considerations, you can ensure that your clinical trial software not only complies with relevant regulations but also maintains the highest standards of data security, safeguarding both patient information and your organization’s reputation.

Evaluating the return on investment in clinical trial software is crucial. Understanding which KPIs to track can provide valuable insights into the effectiveness and efficiency of your medical trial software development efforts. Here is the list of the KPIs to measure:

Time-to-Market

• Metric : Reduction in the overall time taken to bring a drug or treatment to market.
• Significance : Faster time-to-market can lead to earlier revenue generation and competitive advantage.

Cost Savings

• Metric : Decrease in operational costs associated with manual data entry, monitoring, and reporting.
• Significance : Lower operational costs contribute directly to improved bottom-line performance.

Data Accuracy and Quality

• Metric : Reduction in data discrepancies and errors.
• Significance : High data quality ensures reliable trial results and regulatory compliance, reducing the risk of costly rework.

Patient Enrollment and Retention Rates

• Metric : Increase in patient enrollment speed and retention rates throughout the trial.
• Significance : Efficient patient management leads to more robust trials and faster completion times.
• Metric : Number of compliance issues or regulatory flags reported.
• Significance : Ensuring compliance reduces the risk of legal penalties and trial delays.

User Adoption and Satisfaction

• Metric : User satisfaction scores and system adoption rates among staff.
• Significance : A high adoption rate indicates the software is user-friendly and meets the needs of its users.

Operational Efficiency

• Metric : Improvement in workflow efficiency, such as reduced time for data entry and document management.
• Significance : Enhanced efficiency leads to higher productivity and lower costs.

System Uptime Ratio

• Metric : Percentage of time the clinical trial software is operational and accessible.
• Significance : Higher uptime ratios ensure continuous access to critical trial information and reduce disruptions in trial operations.

Ratio of IT Incidents per Employee

• Metric : Number of IT-related incidents reported per employee.
• Significance : Lower incident ratios indicate a stable and reliable IT environment, contributing to smoother trial operations.

Return on Investment (ROI)

• Metric : Overall financial return generated from the implementation of the software compared to its cost.
• Significance : A favorable ROI demonstrates the financial viability and success of the software investment.

Tracking these KPIs will provide a comprehensive view of how well your clinical trial software development project is performing. By focusing on these metrics, you can make data-driven decisions that enhance trial efficiency, reduce costs, and ultimately improve patient outcomes.

While the investment in clinical trial software can be substantial, the long-term benefits often outweigh the initial expenses. Here’s a breakdown of the costs to help you plan and budget effectively:

Initial Development Costs

Initial development costs encompass discovery, coding, testing, project management, and more. On average, these expenses total around $120,000. Notably, with this investment, you don’t have to pay for each user individually, and you have the potential to monetize the solution further by offering it via a SaaS model to other organizations.

Recurring Costs

For SaaS-based solutions, recurring costs range from $25 to $400 per user per month, depending on the subscription plan and features required. Unlike custom development, these recurring costs eliminate the need for upfront development expenses.

Factors Influencing Costs

Scope and complexity.

• More complex systems with advanced features, such as AI-driven analytics or telemedicine integration, will naturally incur higher development costs.
• Ensuring that the software meets regulatory standards (e.g., HIPAA, GDPR) adds to the cost due to the necessary data security measures and audit trails.

Customization and Scalability

• Customizable and scalable solutions designed to meet specific trial needs and accommodate growth will increase overall costs but offer significant long-term value.

Interoperability

• Integrating the new software with existing systems like EHRs or laboratory information systems requires additional development efforts, contributing to higher costs.

User Interface (UI) and User Experience (UX)

• Designing intuitive and user-friendly interfaces requires significant investment in user research and iterative improvements to ensure ease of use and adoption.

Investing in clinical trial software also paves the way for opportunities to develop an EHR/EMR system , further enhancing interoperability and data management capabilities.

One remarkable example is the implementation of a CTMS at the Medical University of South Carolina (MUSC). The Medical University of South Carolina (MUSC) faced challenges in managing its diverse and complex clinical trials. To address these issues, MUSC implemented a CTMS integrated with its Research Integrated Network of Systems (RINS). The results were transformative.

Key Achievements:

• Enhanced Efficiency : Within the first year, the CTMS managed 324 protocols and enrolled over 2,600 participants. The streamlined operations significantly reduced administrative burdens and improved overall trial efficiency.
• Improved Patient Accrual : The integration enabled near-real-time assessment of patient accrual, allowing for quicker identification and enrollment of eligible participants. This not only sped up the trial process but also enhanced the accuracy of patient data management.
• Accelerated Reimbursement : The system’s ability to provide real-time data and comprehensive financial tracking led to accelerated reimbursement from industry sponsors. This improvement in financial management contributed to better cash flow and sustainability of the trials.
• Financial Performance : By enhancing operational efficiency and enabling precise financial tracking, the CTMS improved the financial performance of clinical trials. The system provided clear visibility into budget utilization, cost management, and financial outcomes.

The successful implementation of a CTMS at MUSC underscores the significant impact that advanced clinical trial management systems can have on research institutions. By integrating a robust CTMS with existing systems like RINS, healthcare organizations can achieve remarkable improvements in efficiency, patient management, and financial performance.

In the rapidly evolving landscape of clinical trial management, staying updated with emerging trends is crucial for decision makers. Here are some key trends to watch:

• Enhances data analysis, patient recruitment, and predictive analytics.
• Ensures tamper-proof data integrity, enhancing regulatory compliance and trust.
• Expands access to diverse patient populations and reduces logistical barriers.
• Facilitates real-time patient monitoring and data collection outside clinical settings.
• Offers scalability, flexibility, and cost-effectiveness in managing trial data and processes.
• Prioritizes user-friendly interfaces and patient engagement tools to improve trial participation.
• Utilizes big data to optimize trial design, site selection, and patient outcomes.

At Topflight, we understand the unique challenges faced by decision-makers in the development and deployment of clinical trial software. Our expertise in medical and healthcare software development is demonstrated through our successful collaborations with leading institutions and companies. Here’s how we address these challenges:

Ensuring Compliance and Data Security

Case Study: iFaint App

Our work with Medable through the Stanford University School of Medicine on the iFaint study involved developing a HIPAA-compliant custom dashboard for iOS and Android. This app visualizes data collected from wearable devices tracking participants’ heart rates. By leveraging Healthkit and Google Fit, we ensured secure and compliant data integration.

• HIPAA Compliance : Strict adherence to regulations ensures data security and patient privacy.
• Cross-Platform Integration : Seamlessly integrating with both iOS and Android ecosystems via Healthkit and Google Fit.

Enhancing Real-Time Data Visualization and Analysis

Case Study: Fortune 100 Pharmaceutical Company (see project #2)

We partnered with a Fortune 100 pharmaceutical company to design and develop a dashboard for visualizing and analyzing remote clinical trial study results. Using the Medable Axon App and API, along with IoT devices (a smart flowmeter and a smart pillbox), we created a real-time data visualization dashboard that provided comprehensive insights to clinical trial managers.

• IoT Integration : Integrating smart devices for real-time data collection and analysis.
• Rapid Development : Completed the project in just two months, emphasizing our efficiency and expertise.
• Data-Driven Insights : Empowering trial managers with actionable data to make informed decisions quickly.

Facilitating Patient Engagement and Data Accuracy

Case Study: Patient Registry & Symptom Tracking App

Topflight collaborated with Solve ME, the largest non-profit fighting chronic fatigue syndrome (CFS), Long COVID, and other post-infection diseases, to create a patient registry and symptom tracking app aimed at improving patient engagement and data accuracy. This mobile application enables patients to self-report symptoms and participate in research studies, providing researchers with high-quality, real-time data through a web dashboard.

• Patient-Centric Design : Easy-to-use interface encourages patient participation and accurate self-reporting.
• Real-Time Data Collection : Immediate access to patient-reported data enhances the quality and timeliness of research insights.
• Enhanced Research Outcomes : Improved data accuracy leads to more reliable and actionable research findings.

Facilitating User Adoption and Training

To ensure high user adoption rates, we focus on designing intuitive and user-friendly interfaces. Our solutions come with comprehensive training programs tailored to the specific needs of healthcare professionals, ensuring smooth onboarding and effective use of the software.

Addressing Scalability and Customization

Our solutions are designed to be scalable and customizable, allowing them to grow with your organization’s needs. Whether it’s integrating advanced features like AI-driven analytics or ensuring interoperability with existing systems, we provide flexible solutions that align with your business goals.

Managing Cost and Resources Efficiently

Topflight’s approach includes detailed planning and transparent communication, ensuring that all stakeholders are aligned on project goals and budgets. By leveraging our extensive experience and proven methodologies, we deliver cost-effective solutions without compromising on quality or functionality.

Topflight’s track record in addressing the complex challenges of clinical trial software development speaks for itself. Whether it’s ensuring compliance, enhancing data visualization, engaging patients, or facilitating user adoption, we have the expertise and experience to deliver solutions that meet your needs. By partnering with us, you can expect increased efficiency, streamlined workflows, and improved bottom line performance.

Frequently Asked Questions

What is a clinical trial management systtem (ctms).

A CTMS is software designed to streamline the planning, tracking, and management of clinical trials, enhancing efficiency and data accuracy.

Wy is CTMS important in clinical trials?

CTMS improves trial efficiency, compliance, and data quality by automating processes, managing patient recruitment, and providing real-time data insights.

How are regulatory compliance and clinical trials solutions ensured?

Compliance is ensured through adherence to industry regulations like HIPAA, utilizing secure data protocols, and conducting regular audits.

What are the challenges of deploying a new clinical trial software?

Challenges include user adoption, data migration, integration with existing systems, and ensuring regulatory compliance.

How do clinical trial platforms enhance patient engagement and retention?

They offer user-friendly interfaces, real-time symptom tracking, and personalized feedback, making participation easier and more engaging for patients.

Is clinical trial software safe and secure?

Yes, clinical trial software employs advanced security measures like encryption, access controls, and compliance with data protection regulations to ensure safety.

Can clinical trial software integrate with other systems?

Absolutely. Modern clinical trial software is designed to seamlessly integrate with existing healthcare IT systems and platforms.

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The perspectives and opinions expressed in this material represent those of the patient advocate only and should not be considered a solicitation, promotion or advertisement for any services of Parexel, or any drugs or therapies, including those under development. Participating in clinical trials for investigational medicines offers patients potential benefits, such as access to cutting-edge treatments and expert medical care, while contributing to medical research. However, risks may include side effects, unpredictable outcomes, and time commitment. Careful assessment of these factors helps patients make informed decisions. The content of this material, including graphics, images and text, is provided for informational purposes only and does not constitute medical advice, diagnosis or treatment. Please consult your healthcare professional for medical advice. The patient advocate has provided their consent for the use and distribution of this content.

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Tina had lost her father to Crohn's disease. Now she faced her own diagnosis.

Then came the diagnosis. Finding out she had Crohn’s disease, one of two IBD syndromes that affect 10 million people worldwide, wasn’t a surprise considering her family’s history with the disease. But it derailed her life.

Tina was in her early 20s. She lived in New York City and was building a promising future for herself in finance.

She spent the next 10 years trying countless medications and underwent 20 surgeries. nothing worked., then, finally, she enrolled in a clinical trial., within months, she was in remission—and has been ever since., today, she’s a patient advocate, sharing her experiences to help keep our clinical trials focused on the needs of patients like her., lives can change when you design inflammation and immunology trials with agility, precision, and care..

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Mwango brings over 20 years of clinical and regulatory drug development experience to her role at Parexel, including more than 16 years at the U.S. Food and Drug Administration (FDA).  She provides strategic and technical guidance on various regulatory and clinical aspects of drug development, leveraging her expertise in clinical review, pharmacovigilance and post-approval safety requirements across multiple therapeutic areas.  Mwango is a critical asset for our customers, helping them navigate the changing regulatory environment on their development journeys to deliver important new treatments to patients in need across the globe.

Our I&I team is 13,100+ strong, with experience across indications, to match the needs of your trial.

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We focus on patients, because they inspire us to deliver better trials, faster than ever. So we can make a difference for more patients like Tina.

Who we are,, parexel is proudly among the world’s largest clinical research organizations.

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Clinical Research Assistant – Per Diem – Grant Funded

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Whether you are looking for a new career opportunity or looking for care for yourself or a family member, you’ll find what you need at Scripps. We treat more than 700,000 patients annually through the dedication of 3,000 affiliated physicians and more than 15,000 employees among our five acute-care hospital campuses, hospice and home health care services, 30 outpatient centers and clinics, and hundreds of affiliated physician offices throughout the region.

Scripps Health Administrative Services supports our five hospitals and 19 outpatient facilities, which treat half a million patients annually through 2,600 affiliated physicians.

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Job description.

This is a per diem/casual, partial remote position located at La Jolla. The schedule would be 8 hour day shifts on weekdays. This is a grant funded role through 5/31/2025.

Join the Scripps Health team and work alongside passionate caregivers and provide patient-centered healthcare. Receive endless appreciation while you build a rewarding career with one of the most respected healthcare organizations nationwide. 

  Why join Scripps Health? 

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Scripps Health is committed to providing the best possible patient care, and research is a critical part of that mission. In addition to bringing the latest treatments to our patients, the knowledge gained from these research studies advances the quality of care for people around the world. The Clinical Research Services team is responsible for feasibility and research coordination for all clinical trials across all specialties. Our research team is growing and we are excited to be part of progressive clinical trials that will contribute and assist our patients in living their best lives.

This position is ideal for someone who is a fast learner, interested in research and experienced with patient care.  The responsibilities of the Research Assistant – Clinical include:

• Help coordinate multiple aspects of clinical trials and other human research ensuring compliance with research protocol and IRB requirements.
• Manage regulatory documents and data submission, assist with IRB submissions, responsible for keeping internal data tracking systems up to date.
• Provide superior service to principal investigators and research sponsors within scope of responsibilities.

In compliance with the California Pay Transparency Act, Scripps Health posts the pay range for all jobs. Please note that actual pay will be determined based on relevant experience and internal equity within the pay range. Please also note this range is applicable for employees who reside in California only. A geographical pay differential may be applied for remote employees who reside out of state. Scripps Health strives to ensure that our employees receive equal pay for equal work in line with our commitment to being an equal opportunity employer.

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• 1 Year in health care setting OR Allied Health professional degree.
• Advanced written, oral and interpersonal communication skills.
• Strong prioritization, organizational, and problem solving skills.
• Strong motivator/communicator in a compact clinical team working with aggressive timelines.
• Strong computer skills with Microsoft Office software.
• BLS through American Heart Association.

Preferred Qualifications:

• Proficiency in medical terminology.
• Research experience.

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Smooth Drug Development offers a full range of clinical development services in Europe and Asia (Baltic States, Belarus, Bulgaria, Hungary, Germany, Moldova, Russia, Serbia, Spain, Slovakia, India, Kazakhstan, Uzbekistan). It includes project managem...

ACROSS Global in Russia

E-mail:   [email protected]

Web:   www.across.global

Synergy Research Group Russia

Address: 33/2, Usacheva St., Moscow, 119048

Phone:   +74956004445

Local, small- and mid-size Contract Research Organizations in Russia

We are a full-service clinical CRO with a relentless mission to complete your clinical trial on time. Backed by our strong operational strategy and leadership, a devoted team of medical professionals in each country and connections to prominent medic... View full profile

• United States

At Atlant Clinical, we work hand-in-hand with the world’s leading biotech and pharmaceutical companies. Our preferred supplier status with some of the biggest names in the industry confirms we have the insight and daily experience to manage your proj... View full profile

International logistics of temperature-sensitive cargoes in the field of health care and clinical research. We have been working for over 13 years and our employees have a regular training program Your shipment will be in the right place on time. We... View full profile

A Contract Research Organization that specializes in organization and conducting of international and local clinical trials in Russia. Here you can find information about our services, contact details, history and experience. We will familiarize you... View full profile

Congenix is an independent contract research organization offering its clients a full range of services, covering the organization and implementation of clinical trials on phases I to IV in the Russian Federation and former Soviet countries. Our miss... View full profile

• United Kingdom

We go beyond testing, inspecting and certifying products; we are a Total Quality Assurance provider to industries worldwide. Through our global network of state-of-the-art facilities and industry-leading technical expertise we provide innovative and... View full profile

IPHARMA is a contract research organization focusing on conducting clinical trials and registration of investigational drugs and medical devices in Russia and EAEU. IPHARMA is a member of ChemRar High-Tech Center group of companies and an accredited... View full profile

Modern Medical Innovations is a new CRO in Russia with highly experienced and motivated team. We work across all EAEU countries (Kazakhstan, Armenia, Belarus). Our employees have extensive experience and expertise in the field of clinical research, r... View full profile

RusClinic CRO is a consulting company that has been successfully providing its services in the Russian pharmaceutical and medical markets for more than 20 years. RusCliniC CRO company was created by a team of professionals with extensive experience i... View full profile

Global Contract Research Organizations in Russia

ACROSS Global is a unique, full-service, comprehensive alliance of qualified CROs and Specialist Service Providers dedicated to providing a professional, cost-effective, focused, and seamless service to the pharmaceutical, biopharma and medical devic... View full profile

• Bosnia & Herzegovina
• Congo, DR of
• Philippines
• Saudi Arabia
• South Africa
• South Korea
• Switzerland
• United Arab Emirates

With 15 years of experience, we have defined a process that consistently achieves success for our clients.RESEARCH that uncovers the real needs and delivers actionable insights.At the heart of any healthcare challenge lies a compelling narrative. To... View full profile

A global, full-service contract research organization. We take your trials personally. dMed Global, a full-service Clinical Contract Research Organization (CRO) based in Shanghai, China and Clinipace Incorporated, a full-service Clinical CRO with hea... View full profile

• Czech Republic

Cromos Pharma is a US-based, international contract research organization delivering fully integrated clinical research solutions, in all trial phases, across a wide range of therapeutic indications. Our expert team, comprised of 95% MDs, has extensi... View full profile

Established in 1995, Dokumeds has been expanding its coverage and services significantly over 25 years of operations. Gradual geographical and operational coverage expansion correlated with company staff growth and lowering of employee turnover to an... View full profile

• Netherlands

Emergo by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Our comprehensive solution is designed to help you achieve and maintain regulatory and commercial success. With a presence on six continent... View full profile

As a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions and other enabling services, Fortrea partners with emerging and large biopharma and medical device and diagnostic companies t... View full profile

• New Zealand

Global Clinical Trials, LLC is a full-service CRO with offices and operations in the United States, Europe and Asia. Our professional staff have been sharing their unique experience and utilizing established contacts with the key opinion leaders (KOL... View full profile

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We are a global provider of consulting, and outsourced developme... View full profile

IMS Health and Quintiles are now IQVIA, a world leader in using data, technology, advanced analytics and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, m... View full profile

MB Quest was founded in Moscow in 1997 as one of the first international CROs to work in Russia. We provide Sponsors with a full range of clinical trial services in Russia, Ukraine, Belarus, Georgia, and Kazakhstan. Our offices are located in the lar... View full profile

Our unique global partnering philosophy emphasizes an uncompromising commitment to clinical research and to the highest level of ethical standards and performance in our jobs. We are selective about the projects we engage in because we are devoted to... View full profile

OCT is one of the leading Eastern European contract research organizations. Since 2005, we have conducted hundreds of clinical trials in Eastern Europe, in both CEE and the CIS. Our team of 200+ professionals provides a full range of high-quality CRO... View full profile

For over 35 years, PAREXEL has proven to be a trusted partner for the complex development journey required of biopharmaceutical and medical device companies. We’re also an astute guide, able to simplify that journey for our clients, so safe new produ... View full profile

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and go... View full profile

Our mission is to be the best CRO in the world as measured by our employees, clients, investigators, and vendors. Our teams work tirelessly to ensure that we deliver on time and on budget. You will always know what's going on with your study when you... View full profile

SanaClis is a full-service Global CRO with a fully integrated clinical supply chain, thereby offering a comprehensive range of end-to-end services for clinical trials. SanaClis was founded in 2000 by seasoned industry experts, all of whom have had ex... View full profile

Life sciences services from SGS – optimize your development timelines to get medicines and medical devices to market quickly and safely. There is no other area of business that is more heavily regulated than the development, testing and distribution... View full profile

• Burkina Faso
• Cote d'Ivoire
• Dominican Republic
• El Salvador
• Equatorial Guinea
• Papua New Guinea
• Saint Lucia
• Trinidad & Tobago
• Turkmenistan

Smooth Drug Development offers a full range of clinical development services in Europe and Asia (Baltic States, Belarus, Bulgaria, Hungary, Germany, Moldova, Russia, Serbia, Spain, Slovakia, India, Kazakhstan, Uzbekistan). It includes project managem... View full profile

Syneos Health (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, strategically blending clinical development, medical affairs a... View full profile

X7 Research is a new generation CRO providing a vast range of services in the EU, CIS, USA and Asia. X7 Research is a CRO of just the right size, where the clients’ needs are always first priority. As a result, 100% of our initial customers return to... View full profile

List of CROs by location

INVITRO is a provider of full Central laboratory services and Clinical trial management services for Phase I-IV.

INVITRO Laboratory also performs Local laboratory services for International clinical trials. Because of our broad experience and specialized expertise, we’re in unique position to support safety laboratory tests as an alternative to the different site bases.

Local laboratory services are offered for Russia, Belarus and Kazakhstan

INVITRO Clinical Research can use its own Courier logistics service for pick-up and delivery of samples to the laboratory.

Due to the absence of custom between these countries, we are one of the small groups of organization with the capability and expertise to conduct Laboratory services and development projects for either local or global clinical trials.

All the tests for Clinical trials are performed in the Moscow laboratory.

It is stocked with high-tech equipment and located in a space of 3 500 sqm including:

• 365 work days per year, including monitoring and registration of biological samples around the clock
• Quality assurance of laboratory services in accordance with ISO 9001, ISO 15189 certificates
• Validated methodologies, logistical and data management support, reliable and flexible reporting systems and cohesive quality control, which are critical to meet the requirements of your organization and regulatory agencies.

Our Project teams perform ongoing monitoring and proactive communications to provide high-quality outcomes. Protocol specifications are built in during database setup to provide customized reports and sophisticated result flagging for monitoring. Our secure Internet-based, remote data access system allows members of the project team to review lab results in real time. INVITRO scientists, technologists and project managers can assist with protocol development to provide the most appropriate tests for each study, and all INVITRO staff is trained and certified accordingly. INVITRO Laboratory offers the flexibility required for quick and customized responses to unique client needs for any size project.

We strongly believe that a collaborative relationship between INVITRO Laboratory and Clinical Investigators is fundamental study success.

We provide:

• Design of study-specific manual
• Lab Kit manufacturing in accordance with GLP requirements
• Study-specific requisition forms and courier documents
• Biomaterial transportation in compliance with IATA requirements
• Telephone assistance
• Specimen handling
• Long-Term Storage and frozen specimen tracking
• Personal Account of clinical trials – an opportunity to use a tool that allows you to monitor the results of laboratory research, query, order a courier and lab kits online and have access to laboratory documents and project -specific documents

INVITRO clinical research

• Patient service
• Project Management
• Request for proposal

Invitro Clinical Research

INVITRO Clinical Research has supported clinical study teams at pharma companies and CROs facing the challenges of recruiting study subjects

www.invitro-cr.com

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Lighting the Way to Detect Tumors During Surgery

CYTALUX binds to a tumor in the lung and glows brightly.

In 2010, a company called On Target Laboratories, based in West Lafayette, Indiana, was founded with the goal of helping doctors find cancers more easily during surgery. Their first product was CYTALUX (pafolacianine), a molecule that makes even the tiniest of tumors glow brightly in the operating room. Today, surgeons are finding tumors in lungs and ovaries more easily using this first-of-its kind tool. But the path to bring CYTALUX from the laboratory into the operating room took a lot of persistence from the small start-up company—a journey that was helped along with support from  NCI’s Small Business Innovation Research (SBIR) program .

Seeing the need for innovation 

Sumith Kularatne, Ph.D., vice president of research and development for On Target, was part of the original team that envisioned the potential of a tool like CYTALUX. Having lost his grandfather to cancer when he was a young boy in Sri Lanka, Sumith has spent much of his life blending his love of chemistry with a strong desire to help families affected by cancer. This led him to the United States, where he eventually began researching molecules that could help reveal cancer cells during surgery in real time.

“Surgeons are dealing with a challenging situation,” Sumith explained. Sometimes, a tumor is buried underneath the surface of an organ, rendering it invisible to the naked eye. At other times, a tumor may be too small or not solid enough for a surgeon to feel it with their fingers or surgical instruments. These pitfalls, he continued, inspired On Target to develop a technology that could enhance the surgeon’s sense of sight—like a pair of tumor-revealing glasses.

Advancing innovative research and technologies is the goal of NCI’s SBIR program, which funds researcher-initiated projects that align with NCI’s mission. Through the federal SBIR program, small businesses can receive funding, resources, and other support to help drive innovative technologies like CYTALUX into the marketplace to benefit patients.

Making tumors glow

CYTALUX is a modified version of folate, commonly known as vitamin B9, that is attached to a fluorescent dye. There are many more folate receptors on the surface of certain tumors than on surrounding cells in the body. This overabundance of folate receptors provides a target that researchers can use to shuttle cargo, such as the fluorescent dye in CYTALUX, to a tumor’s location.

Once CYTALUX binds to folate receptors and enters tumor cells, a special camera used during surgery causes the dye to emit a bright green signal. This approach, the team found, worked well in  animal models of ovarian cancer, the cancer type with the largest concentration of folate receptors.

A logical next step was to test CYTALUX in lung cancer, which has a high proportion of folate receptors and causes more deaths in the United States than any other cancer. While surgery remains the gold standard for treating early-stage lung cancers, as many as a third to half of these cancers return, likely because some tumors or tumor cells remained behind after the initial surgery.

With limited funding options for the highly experimental work, the On Target team competed for and received a phase 1 SBIR grant to study CYTALUX for lung cancer in animal models. Two years later, with promising data in hand, the group received an additional phase 2 SBIR award to conduct more studies and scale up production of CYTALUX.

Others took notice of the company’s success. On Target was selected to participate in  SBIR Investor Initiatives , an NCI-sponsored program that helps SBIR and Small Business Technology Transfer award recipients present their technology to investors and strategic partners.

Catalyzed by NCI’s Investor Initiatives contacts, On Target received $40 million in private financing. Those partnerships opened the door to more investors and eventually garnered the company enough support to launch clinical trials testing CYTALUX during surgeries to remove tumors in people with lung and ovarian cancers.

A shining return on investment

Surgeons were impressed. In those clinical trials, they saw the borders of tumors in real time, cutting out the cancer while preserving as much of the unaffected organ tissue as possible. They even removed cancers that they would have missed without CYTALUX because the tumors were not visible on scans.

In late 2021, the Food and Drug Administration (FDA) approved CYTALUX as an optical imaging agent for adults with ovarian cancer. Approval for adults with lung cancer followed a year later.

Almost 10 years after its first SBIR grant, On Target officially launched CYTALUX, making it commercially available in September 2023. It is now the first FDA-approved imaging agent to detect cancers in the lung and ovaries during surgery in real time.

“The [SBIR] grant helped us understand the full potential of what we have with CYTALUX,” said Tim Biro, R.Ph., chief operating officer of On Target, who along with Sumith is one of the longest-serving members of the company. His gratitude for the chance to see the technology get developed and the company grow from three employees to more than 30 is evident. “SBIR support was really important to the company at that early stage.”

If you ask Sumith about the importance of this work, he’d tell you that the return on investment is simple: “a better outcome for patients with cancer and their families.”

Working together, we can reimagine medicine to improve and extend people’s lives.

Associate Director, Non-Clinical Statistics

About the role.

Major accountabilities:

·         Collaboration: Work closely with scientists, project teams, and disease areas to integrate statistical methodologies into research and development processes.

·         Statistical Support: Provide expert statistical support for non-clinical studies, ensuring robust data analysis and interpretation.

·         Innovation: Contribute to the development and application of innovative statistical techniques

·         Training and Mentorship: Mentor junior statisticians and data scientists, promoting a culture of continuous learning and professional growth..

·         Cross-Functional Representation: Represent non-clinical statistics on cross-functional teams to provide effective statistical consideration and collaborate closely with scientists across Biomedical Research.

·         Statistical Approaches: Ensure and implement statistically sound approaches for the design, analysis, reporting, and interpretation of exploratory and regulatory non-clinical studies.

Automation Development: Develop automated solutions

Education: Ph.D. or Masters in Statistics, Biostatistics, or a related field strongly preferred. 

• Experience: Minimum of 6 years of experience in non-clinical statistics, with a strong working knowledge in biology, pharmacology and toxicology .  
• Technical Skills : Expertise in statistical software and programming languages (e.g., R, SAS, Python).  
• Communication: Excellent communication and interpersonal skills, with the ability to engage effectively with diverse stakeholders.  
• Innovation: Demonstrated ability to drive methodological innovation and apply advanced statistical techniques to complex problems.  
• Fluent in English (oral and written) .    

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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News & Insights

5 US Longevity and Anti-aging Stocks to Watch in 2024

September 04, 2024 — 04:15 pm EDT

Written by Melissa Pistilli for Investing News Network  ->

As the percentage of the global population over 65 continues to increase , the popularity of anti-aging stocks is rising in tandem thanks to advancements in technology and a growing body of research on human longevity.

The desire to increase life quality and expectancy is what drives the top anti-aging stocks in the life science space as they pursue technologies and therapies aimed at slowing the aging process and preserving health. Age-related diseases are a main focus of this sector, including cancers, cardiovascular diseases, Alzheimer's disease, Parkinson's disease and osteoarthritis.

Analysts are expecting the longevity and anti-aging therapy sector to develop into a multibillion-dollar industry in the coming years. It had an estimated market value of US$600 million in 2023, and Verified Market Reports is projecting that value to increase at a compound annual growth rate of 18 percent through 2030 to reach US$3.6 billion .

For those considering which anti-aging stocks to invest in, below is a brief overview of five NASDAQ-listed stocks with market caps between US$50 million and US$500 million. NYSE companies were considered but didn't make the cut.

All company figures were current as of August 9, 2024.

1. GRAIL (NASDAQ:GRAL)

Market cap: US$477.225 million

California-based GRAIL is focused on the area of precision oncology through early cancer detection technology. The healthcare company has developed a methylation-based multi-cancer early detection platform known as Galleri. It incorporates next-generation sequencing and large-scale clinical studies with machine learning, software and automation to detect and identify multiple types of cancer and monitor for reoccurrence.

This year, GRAIL launched a three-year study to evaluate the clinical impact of the Galleri multi-cancer early detection test in the Medicare population by assessing the safety of the test and any reduction in diagnosed stage IV cancers in a population of about 50,000 people receiving the test annually compared to a group not receiving it. The US Food and Drug Administration (FDA) has granted GRAIL an Investigational Device Exemption for the trial.

2. Verve Therapeutics (NASDAQ:VERV)

Market cap: US$394.35 million

Clinical-stage Verve Therapeutics is developing single-course gene-editing treatments for lowering LDL cholesterol (the "bad" cholesterol), which is closely linked to atherosclerotic cardiovascular diseases — the leading cause of death globally.

In early August, the company provided an update on its clinical progress in 2024 and future catalysts over the next year.

“Our Heart-2 Phase 1b clinical trial of VERVE-102 continues to progress as we focus on enrolling patients and expanding the trial’s geographic footprint, highlighted by our recent regulatory clearance in Australia," stated Verve co-founder and CEO Sekar Kathiresan.

"We look forward to providing initial data from the Heart-2 clinical trial in the first half of 2025. In addition, we are on track to initiate the Phase 1b clinical trial for our ANGPTL3 product candidate, VERVE-201, in the second half of this year, and we continue to advance our early-stage programs, including one targeting the LPA gene.”

3. Anika Therapeutics (NASDAQ:ANIK)

Market cap: US$372.474 million

Headquartered in Boston, Massachusetts, Anika Therapeutics is focused on advancements in early intervention orthopedic care and joint preservation. The company is developing minimally invasive products that leverage its expertise in hyaluronic acid and implants to restore active living for patients. Its target areas include age-related and injury-related fields such as osteoarthritis pain management, regenerative solutions, sports medicine and arthrosurface joint implants.

In its Q2 2024 financial report , Anika highlighted strong revenue growth of 17 percent in the first half of the year for international sales in its osteoarthritis pain management division.

“OA Pain Management remains a strong, foundational element of our business and represents a key aspect of total company profitability,” Cheryl R. Blanchard, Anika Therapeutics president and CEO, stated in the release.

4. Ocugen (NASDAQ:OCGN)

Market cap: US$374.22 million

Pennsylvania’s Ocugen is working to bring to market gene and cell therapies for the treatment of ocular and orthopedic conditions.

Its product pipeline includes OCU400, which received orphan drug designation. It is currently in Phase 3 clinical trials for treatment of retinitis pigmentosa, and is being tested on a group of patients with RHO mutations and a group with other related gene-mutations.

It is also developing OCU410, a modifier gene therapy targeting geographic atrophy, an advanced stage of dry age-related macular degeneration. It leverages a nuclear hormone receptor gene called RORA and is a single sub-retinal injection that has the potential to be a one-time therapy for life. According to the company, current treatment options require 6 to 12 doses per year.

In the first half of 2024 , Ocugen made significant progress in its Phase 2 OCU410 clinical trial, and preliminary safety and efficacy data is expected later this year.

Another therapy in Ocugen's pipeline is NEOCART, a regenerative cell therapy for the treatment of articular cartilage defects in the knee that can lead to osteoarthritis. The company intends to launch the Phase 3 trial for NEOCART once it can secure adequate funding.

5. Lyell Immunopharma (NASDAQ:LYEL)

Market cap: US$348.164 million

San Francisco-based Lyell Immunopharma is advancing a diverse pipeline of CAR T-cell reprogramming therapies targeting solid tumors. The clinical-stage company’s pipeline includes product candidates entering Phase 1 studies in various indications including triple-negative breast cancer, non-small cell lung cancer, ovarian cancer, endometrial cancer, melanoma and colorectal cancer.

In its Q2 2024 report , Lyell provided an update on its Phase 1 LYL119, for which the FDA recently gave investigational new drug clearance. The trial is studying the drug candidate's use for treating patients with ROR1-positive, platinum-resistant ovarian cancer or endometrial cancer. A report on the initial clinical data is expected in H2 2025.

FAQs for longevity and anti-aging

​will we be able to reverse aging in the future.

While research on reverse aging is growing, a recent article in Popular Science throws cold water on those dreaming of turning back the clock on their bodies. Studies on reversing age have mostly focused on aging mice — not humans — and Popular Science says research on humans will be necessary to see promise in this field.

​Which billionaire is trying to reverse aging?

While not a billionaire, Tech CEO Bryan Johnson is reportedly spending up to US$2 million per year on medical tests and various procedures aimed at reversing his body’s natural aging process. However, longevity experts don’t think he has discovered the proverbial fountain of youth.

​What is the latest anti-aging cell technology?

The latest anti-aging cell therapy uses CAR-T cells , a type of white blood cell that help bolster the immune system. CAR stands for chimeric antigen receptor and researchers believe that they can reprogram these cells to become cancer killers or even reverse cellular aging.

This is an updated version of an article originally published by the Investing News Network in 2017.

Don’t forget to follow us @INN_LifeScience for real-time news updates.

Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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