Introduction
Managing clinical trials has become increasingly complex with evolving regulations, advancing technologies and rising stakeholder expectations. Clinical trial management software (CTMS) helps streamline operations, maintain compliance and accelerate development timelines. With so many options available today, choosing the right CTMS can be challenging. This guide evaluates the leading CTMS platforms based on key criteria to help identify the best solutions.
Methods of Evaluation
The top CTMS solutions were evaluated based on platform features, integrations, mobile capabilities, data analytics/visualization, customer reviews, security certifications, pricing and popularity online measured by metrics like number of backlinks, traffic and keyword search trends. Special consideration was also given to platforms offering end-to-end clinical trial capabilities from protocol development through submission versus those focused on certain phases/indications. The goal was to provide a well-rounded assessment of each vendor factoring in both qualitative and quantitative criteria.
1. Veeva Vault Edc
Veeva Vault Edc is a cloud-based electronic data capture (EDC) software product developed by Veeva Systems, a leader in cloud-based solutions for the life sciences industry. Veeva Vault Edc allows sponsors and CROs to efficiently capture clinical trial data in a centralized, configurable platform that is part of Veeva’s integrated Vault Clinical Suite.
Pros: Key advantages of Veeva Vault Edc include:
– Part of an integrated Veeva suite for end-to-end clinical processes
– Allows configurable dashboard views of trial metrics and KPIs
– Robust data capture capabilities with features like branching logic, calculations and automated checks
Cons: A potential disadvantage is that it requires additional investment and contract with Veeva as part of their full clinical suite. Some customers may prefer standalone best-of-breed solutions.
Pricing: Veeva Vault Edc pricing is variable depending on the size and needs of the customer’s clinical program. It is typically sold as part of Veeva’s overall Vault Clinical Suite offerings which include flexible subscription models.
Some key stats about Veeva Vault Edc include: –
– Used by over 500 customers globally for their clinical trials
– Overseen the capture of data from over 5 million patients
– Integrates with other Veeva products like Veeva Vault CDMS for seamless data collection
2. Clario
Clario is a leading clinical trial technology and operations partner for the biopharma industry. Founded in 2011, Clario helps sponsors, CROs and sites conduct smarter, faster and more patient-centric clinical trials. With deep therapeutic expertise and global scale, Clario delivers the richest clinical evidence through its end-to-end decentralized and hybrid trial solutions across operations, medtech, software, AI/analytics and consulting.
Pros: Some key advantages of Clario include:
– It is well-known sponsor and CRO partner due to its scale and experience.
– It offers easy to use participant engagement tools that can help improve recruitment and retention.
– It provides a holistic view across trials with its unified technology platform.
Cons: One potential disadvantage is that as a larger company, Clario may not be as nimble or customizable as smaller clinical trial software providers.
Pricing: Clario offers various pricing models depending on the specific needs and use cases. Pricing is available upon request for a customized quote after evaluating requirements.
Some key stats about Clario include:
– Over 350 customers in 50+ countries
– 15,000+ clinical trials supported
– Over 2.5 million participants enrolled
– 30+ therapeutic areas supported
3. Bioclinica
Bioclinica is a leading provider of clinical trial management software with over 20 years of experience. They provide a comprehensive platform to streamline clinical trials from startup to database lock. Some key features of their solution include electronic data capture (EDC), clinical trial management systems (CTMS), clinical data management systems (CDMS), and clinical risk-based monitoring software.
Pros: Some key advantages of Bioclinica’s clinical trial management platform include its wide range of clinical data collection options, powerful programming and CDISC tools, and expert guidance and consulting services.
Cons: As an older and more established vendor, Bioclinica’s user interface may not be as modern or intuitive as some newer platforms. Pricing can also be higher compared to other vendors due to their extensive experience and services offered.
Pricing: Bioclinica offers both yearly subscription and pay-as-you-go pricing models. Subscription pricing depends on the number of trials, users, and selected modules. They also provide customized quotes based on a trial’s specific requirements and needs.
Bioclinica currently manages over 5,000 clinical trials involving over 4 million subjects. They have offices in 13 countries with over 1,000 employees supporting clients. Bioclinica’s clients include top 20 pharmaceutical companies and they have participated in trials leading to FDA approved treatments for various diseases.
4. ArisGlobal LifeSphere
ArisGlobal LifeSphere is an end-to-end fully integrated clinical and safety solution developed by ArisGlobal. It is one of the leading clinical trial management softwares for managing clinical trials from start to finish.
Pros: Some key advantages of ArisGlobal LifeSphere include – 1) It provides an end-to-end fully integrated solution for clinical development. 2) It natively supports hybrid and decentralized clinical trial models. 3) It offers advanced analytics and insights powered by AI/ML capabilities.
Cons: A potential disadvantage could be the large upfront investment and implementation effort required to deploy the full-featured solution.
Pricing: ArisGlobal LifeSphere pricing is typically offered custom depending on specific needs, deployment size, and modules required. It has both on-premise and SaaS deployment options. Contact ArisGlobal for a custom quote and demo.
Some key stats about ArisGlobal LifeSphere include – It is used by over 300 life sciences companies globally. It supports hybrid and decentralized clinical trial models. It has advanced analytics capabilities powered by AI/ML.
5. OpenClinica
OpenClinica is a free and open source clinical data management system (CDMS) developed by OSEHRA and used by researchers around the world. Originally developed by the National Cancer Institute (NCI), OpenClinica is designed to help organizations design, manage, and monitor clinical trials through all phases of research.
Pros: Some key advantages of OpenClinica include:
– It is free and open source software, making it very cost effective for researchers on budgets
– It supports standard medical data formats like CDISC ODM which allows for easy sharing of data
– It has a large global user community providing peer support as well as opportunities for customization and collaboration
Cons: As free and open source software, OpenClinica does not offer the same level of commercial support or customization services that paid vendors provide. Researchers need to rely more on the user community for support.
Pricing: OpenClinica is free, open source software. There are no software license fees or ongoing subscription costs to use OpenClinica.
Some key stats about OpenClinica include:
– Used at over 500 sites globally including the US, Europe, and Asia
– Supports over 15 languages
– Maintains data standards compliance including CDISC standards
6. Clinc
Clinc is a leading clinical trial management software that provides modern, connected platforms for end-to-end trial management. Founded in 2010 and headquartered in Chicago, Illinois, Clinc has helped hundreds of companies and research organizations to manage their clinical trials and studies.
Pros: Some key advantages of Clinc include:
– Modern, connected platform for end-to-end trial management
– Integrates seamlessly with eClinical tools from various vendors
– Intelligent timeline view for quick visibility into study progress and milestones
Cons: One potential disadvantage is that it may require implementation support for larger clinical trials with complex workflows.
Pricing: Clinc offers flexible pricing plans including:
– Free 30 day trial
– Basic plan starting from $2,000/month
– Custom enterprise plans for larger trials and organizations
Some key stats about Clinc include:
– Over 200 customers in more than 40 countries globally
– Helped manage more than 2,000 clinical trials
– Integrates with 25+ other eClinical systems like EDC, CTMS, IWRS etc.
– Supports both interventional and observational study types
7. Bio-Optronics
Bio-Optronics offers Clinical Conductor, a robust clinical trial management system (CTMS) designed to streamline operations for research sites and networks. Clinical Conductor provides a single platform to manage trials from start to finish, helping organizations improve efficiency, collaboration and compliance.
Pros: Key advantages of Clinical Conductor include:
– Designed primarily for Phase I clinical trials
– Integrated safety and PK/PD modeling capabilities
– Tools for participant recruitment, retention, and engagement
Cons: A potential disadvantage is that some features are more tailored for Phase I trials, so it may not be as feature-rich for later phase trials.
Pricing: Pricing for Clinical Conductor is not publicly listed but is available upon request. Pricing is typically based on the number of studies, users and additional services required.
Some key stats about Clinical Conductor include:
– Used by over 200 sites and CROs worldwide
– Overseen more than 8,000 studies and 500,000 participants
– Integrated with over 40 electronic data capture (EDC) systems
8. Datatrak
Fountayn is a clinical trial management software company that offers a complete portfolio of clinical research software products including EDC, CTMS, DCT, RTMS and Trial Design. Founded in 2020, Fountayn is headquartered in Bengaluru, India and aims to accelerate the reporting of clinical research data from sites to sponsors and regulatory authorities.
Pros: Some key advantages of Fountayn include:
– Full-featured EDC and clinical data management platform
– Built-in features for ePRO, telemedicine and electronic consent
– Flexible platform that can support various study designs and indications
Cons: One potential disadvantage is that as a relatively new company, Fountayn may not have as extensive customer base or implementation experience as some larger, more established clinical trial software vendors.
Pricing: Fountayn offers flexible pricing plans including per site/user pricing as well as enterprise agreements for large clinical trial sponsors. Specific pricing is available upon request for qualified opportunities.
Some key stats about Fountayn include:
– More than 30 employees
– Supports studies across all phases from Phase I to Phase IV
– Over 10 years of experience in clinical trial data management
– Manages data for over 150 studies globally
Conclusion
clinical trials are crucial for developing new treatments and optimizing patient care. By leveraging the right CTMS, organizations can streamline operations, ensure compliance and gain insights to make more informed decisions. This guide highlights some of the most comprehensive and well-regarded CTMS platforms to consider that may help accelerate development timelines and better support sponsors, sites and participants.