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Clinical Trial Management Systems (CTMSs) are software platforms that provide clinical research sites and research study staff with the ability to manage all operational aspects of a clinical trial, both at the study protocol level and participant level. A CTMS platform can help streamline study start-up processes, provide real-time visibility into the status of a study, improve collaboration through automated workflows, and optimize financial management processes.
Effectively leveraging a CTMS platform can allow study sites to manage the complex administrative and logistical challenges of conducting clinical research, but it is important to note that these systems require consistent management and oversight to be utilized efficiently.
Some of the benefits of utilizing a CTMS as a single source of truth for clinical trial operations include:
- Optimized operations by facilitating seamless communication between study sites, clinical research organizations, site solutions services (like WCG), sponsors, and intra-site teams.
- Streamlined study start-up by providing real-time insights into the progress of a trial by tracking study activation milestones, identifying potential bottlenecks during trial start-up, and taking proactive measures to address those delays.
- Tracking and reporting capabilities that promote timely intervention and decision-making when a compliance issue or financial deficit is discovered.
- Comprehensive revenue tracking of completed work on each trial.
Furthermore, CTMS processes for tracking financial workflows reinforce regulatory compliance by ensuring appropriate parties are invoiced properly. The importance of maintaining compliance in clinical research cannot be understated. The potential consequences of noncompliance—including hefty fines, exclusion of a site from receiving payments from the Centers for Medicare and Medicaid Services, and disqualification from access to federal funding for clinical research—are very real and can be devastating.
So, what’s the catch? Like any software system, the data available from the CTMS platform are only as good as the data entered. Education, training, standardization, and communication are essential to a site obtaining the most out of its CTMS platform. Disjointed workflows can degrade the effectiveness of the CTMS platform and result in extended study activation timelines. Proper infrastructure and training are needed to capitalize on the full functionality of the system.
Equipping CTMS Administrators for Success
CTMS administrators should be equipped with the detailed knowledge in the platform’s general capabilities, how the platform will integrate with other required site systems, and the context in which the platform will be used within the operations of the clinical trial. Additionally, CTMS administrators should be well-versed in:
- Study start-up and activation workflows.
- Building calendars and billing grids according to each protocol that are customized to fit within the site-specific study activation workflows.
- Financial data entry for Medicare Coverage Analysis and sponsor budgets associated with each protocol.
- Complex amendment changes that may impact the calendar build and financial entry.
Is it worth the effort to configure the CTMS platform for maximum utilization and optimal data capture? Yes! CTMS platforms are designed to manage, process, and audit the dynamic data generated by clinical research. With the appropriate support team, CTMS functionality can be harnessed to produce improved clinical trial metrics in all areas, especially in the most daunting challenge to every study: study activation. Securing the assistance of experts in CTMS best practices during the critical and often overwhelming study start-up process will accelerate study activation timelines and allow the study teams to focus on recruitment and enrollment activities.
How Can Sites Maximize CTMS Effectiveness?
To leverage CTMS platforms effectively, the site infrastructure should be available to support the utilization of the CTMS platform. The CTMS team should be a group of experts available to troubleshoot any issues, customize the system to create reports that extract meaningful data, train research staff in the usage of the CTMS platform, and develop guides and workflows defining the roles of each study team member and how the different roles affect one another.
Additionally, the time and effort required to set up the protocol within the CTMS should be considered in study timelines and study budgeting, particularly at study start-up. Sufficient time and resources are needed to enter a study into the CTMS platform in a way that primes it for success. Interpreting the protocol into a calendar, entering the Medicare Coverage Analysis, and inputting the Clinical Trial Agreement budget take time, but are necessary to initiate tracking of the trial and its financials in the platform. Assembling a team designated for that task or enlisting the help of specialists is a good strategy to ensure prompt and proficient study management.
Conclusion
CTMS platforms play a vital role in ensuring the integrity and efficiency of clinical trials by providing a robust platform to manage all aspects of the research process, from study design to subject enrollment and reporting. A plan should be formulated to build infrastructure and education around the CTMS platform in cases of underutilization or new implementation. Investing time and resources into a CTMS platform will make it an asset that furnishes revenue to expand research by decreasing study start-up times, optimizing operations, and maximizing revenue recovery from sponsors while minimizing noncompliance risks.
If your site is challenged with the administrative burden of time-consuming and complex CTMS calendar builds, financial entry, and invoice management, WCG is here to help. Get the support your site needs to accelerate your study activation timelines and simplify CTMS management complexities with WCG’s CTMS Study Build & Support Solutions.
Authors: Briana McGinness and Nisio Mercado
