Beyond recruiting and collecting data for your clinical trial, research teams will also need to manage multiple stakeholders, including investigators, clinical research coordinators, Clinical Research Associates (CRAs), sponsors, Contract Research Organizations (CROs), labs and study sites. When managing a trial with multiple hospitals or across multiple countries, this can become complex to ensure that everyone is on track to meet regulatory requirements.
A Clinical Trial Management System (CTMS) can help.
A Clinical Trial Management System is software designed to help manage the operational aspects of clinical research. It can allow you to monitor study sites, participant recruitment, monitoring visits, budgeting, timelines and regulatory documentation all in one place. Using this system will help avoid using multiple spreadsheets and emails and provide an overview of the study and any potential delays.
CTMS platforms can often be confused with Electronic Data Capture systems. While an EDC will be used to capture and manage clinical trial data, a CTMS will assist with managing activities for clinical research.
There are multiple platforms available. Below are 5 CTMS platforms:
This platform is designed for organizations running multi-site clinical trials. It provides a central overview of study milestones, site performance and participant recruitment for clinical operations teams.
One of the benefits of this platform is the integration with other Veeva products. This means that you can manage clinical trial management activities alongside key trial documents. For example, you can link monitoring visit information to the appropriate eTMF (Electronic Trial Master File).
This platform also has tools to help you manage issues and protocol deviations. It will help you to log issues, assign actions and track progression.
Best suited to: Pharmaceutical and biotech companies and CROs running complex multi-site studies.
Medidata (part of Dassault Systèmes) provides clinical trial management tools.
This platform can help manage site monitoring, study management, document tracking, issue management and reporting. Clinical Research Associates (CRAs) can manage monitoring activities and clinical operations teams can monitor participant recruitment, site performance and study milestones.
This platform integrates with other Medidata products. This means that you can have a central source of information by linking to products such as Rave EDC and Medidata eTMF. It helps you to easily access information throughout the trial.
This platform also provides reporting tools which can help provide a clear insight into your study and identify any sites which may need extra attention. Medidata has also been investing in AI capabilities across its clinical research technologies.
Best suited to: Sponsors and CROs looking for integrated tools to help manage clinical trial operations.
Oracle Life Sciences provides tools to help manage different areas of clinical research. This includes study planning, site management and trial monitoring.
This CTMS can help manage investigator and research site management, study tracking, site payments and study monitoring. This can be useful for large trials where multiple sites need to be coordinated.
This platform also provides reporting and alerting features to help clinical operations teams identify any issues.
Oracle also has other clinical research technologies available. This means you can manage other areas of clinical data management, randomization and trial supply. Having these systems integrated can help you manage different areas of research.
Best suited to: Large pharmaceutical companies, global sponsors and CROs running complex clinical research.
IQVIA’s Clinical Trial Management System is part of their Orchestrated Clinical Trials solution. This provides integration across clinical trial operations.
This platform can help manage studies, sites and participants. It can be tailored to suit your research requirements. This can be useful if you are running trials across multiple sites.
IQVIA has been investing in Artificial Intelligence and predictive analytics. This can help research teams identify any potential issues and make more informed decisions.
This platform also has a range of clinical research services and technologies which can be useful for sponsors and CROs.
Best suited to: Pharmaceutical and biotech companies, sponsors and CROs running multi-site studies.
Unlike many of the platforms listed above, which are focused on pharmaceutical sponsors and CROs, this platform is focused on academic and institutional research.
This web-based CTMS is used by academic medical centers, hospitals and research institutions. This can help manage protocol management, participant tracking, regulatory processes, study budgeting and reporting.
The budgeting features can be useful for institutions to track research budgets, study costs and sponsor invoicing. You can also manage participant visits, biospecimen and patient registries.
If you have a research office managing studies across multiple departments, this can help to manage activities in one place. This platform can also be useful for institutions running investigator initiated studies.
Best suited to: Academic medical centers, teaching hospitals, university research departments and institutions running multiple investigator-initiated studies.
Veeva, Medidata and Oracle provide comprehensive clinical operations capabilities.
IQVIA provides integration across trial management activities.
Advarra OnCore provides solutions for academic and institutional research.
Ultimately, you are looking for a CTMS that suits how you run your research.
The most feature rich CTMS may not be the best option for your organization. A pharmaceutical company managing international trials will have different requirements to a research department at a University.
When considering what platform to use, consider:
Does it provide the features you need for your study? Consider how many sites you have, participant tracking, study design and complexity.
Does it integrate with your systems? If it integrates with your EDC, eTMF, EHRs and other research applications, this will help reduce re-keying.
Does it have good regulatory controls? Can you audit, restrict access, have electronic signatures, ensure data integrity and validation?
Does it have good reporting? Can you monitor participant recruitment, site performance, milestone tracking and possible delays?
Is it scalable? Can you manage a larger research portfolio without making daily tasks too complicated?
Remember that just because you purchase a CTMS, it doesn’t mean you will be compliant. You will need to ensure that it is properly validated for your use, documented and that staff are trained.
OG/MF/MSM