Beginner’s Guide to Clinical Trial Management Systems

The days of using spreadsheets to painstakingly track patient enrollment and visits, financial metrics, regulatory documents, and other aspects of a clinical trial are thankfully over for most sites. From the largest research centers to the smallest, sites now recognize that a clinical trial management system (CTMS) can be configured to their needs and can bring powerful efficiencies insights, and compliance to their day-to-day operations.

What is a CTMS?

While other products exist to assist with specific trial activities like data capture, a CTMS centralizes and streamlines the way a trial is conducted, providing an end-to-end solution for managing all aspects of a clinical trial. A CTMS can assist with:

• Managing protocols and tracking/reporting any amendments or deviations
• Communicating with patients to remind them of upcoming visits or procedures
• Managing staff scheduling so that effort is aligned with needs, and downtime/overbookings are minimized
• Promote staff training and compliance with study protocols
• Evaluating financial needs, tracking payments to vendors and participants, and providing billing summaries that identify which costs are routine and which are part of research operations
• Tracking and analyzing patient outreach methods
• Streamlining recruitment tasks and providing real-time updates on participant enrollment
• Managing the supply chain for biospecimens, devices, or other products that will be used in the course of the trial
• Supporting regulatory compliance

Almost all CTMS products include a comprehensive dashboard that enables sites to quickly and easily delve into any of these aspects of trial management, and promptly find the answers they need.

Who needs a CTMS?

As clinical trials become increasingly complex, any site, health system, or network can benefit from the capabilities a CTMS provides.

For example, Yale University’s Center for Clinical Investigation was already using an electronic medical record (EMR) to support daily patient care. When the team learned that their CTMS could strengthen billing and patient-safety compliance, while also streamlining research operations, they chose to leverage an integration between the two technologies. Now, when a medical center patient enrolls in a clinical trial, the CTMS flags that patient and sends information about the study to the EMR. If the participant visits the ER or is admitted to the hospital, the team is alerted. The integration also sends billing designations (routine vs. research) to the EMR, as well as a timeline of protocol procedures, tolerance windows for visits, and more. The research center staff report considerable time savings because now they only have to enter relevant data once; and managing billing compliance also has improved substantially.

Similarly, Velocity Clinical Research (formerly New Horizons), a site network based in Cincinnati, found that by implementing a CTMS, the team was better able to zero in on which recruitment efforts had the biggest payoff. In the end, they were able to recoup 50 percent of what they previously spent on TV advertising and funnel the savings into more efficient strategies. They have also found that the CTMS’s built-in communication tools have reduced patient no-shows by 10 percent.

Any site that is seeking to improve enrollment diversity, upgrade billing accuracy, increase profitability, improve budget forecasting, improve communication with patients or team members, or boost participant engagement can benefit from a CTMS. Not only can a CTMS simplify routine tasks and eliminate redundancy for teams, but all of these advantages can demonstrate to sponsors and CROs that your site is an efficient and organized research partner.

What to look for in a CTMS

Ideally, a CTMS should help your staff to visualize and optimize every aspect of your research portfolio. What are some other ways an efficient and effective CTMS should function? It should:

• Include site-centric standardized workflows. These help streamline and simplify common tasks for staff — which in turn enables them to spend more time with patients and key trial activities. Such shared resources also allow sites to learn and benefit from each other’s experiences, and create a sense of community.
• Integrate with other technology that sites already use, like EMRs, general ledger systems, and eIRBs, eRegulatory management systems, and more. This interoperability helps reduce duplication of tasks and maximizes data quality.
• Release frequent software updates — at least three to four per year — to ensure that sites can nimbly adapt to changing industry requirements, and that PHI and other protected data remains secure
• Employ robust customer support teams to empower sites to do their best work with a minimum of frustration or downtime.
• Demonstrate a high customer retention rate. This indicates that sites are not just using the latest technology, but are realizing significant improvements in recruitment, operations, finances, and regulatory compliance over time.
• Provide two-way communication tools that make it easy to schedule and remind patients of upcoming appointments, increasing their engagement, confidence, and retention.

Advarra has two CTMS systems to assist any type of site in centralizing and optimizing their research operations. OnCore Enterprise Research System best serves academic medical centers and cancer centers that support a large research volume. Clinical Conductor is best suited for health systems, research sites, and site networks.

As your site conducts clinical trials to develop safe and effective treatments, it’s important to operate in a way to maximize time and resources. With so many research studies becoming more complex, using a centralized system to improve clinical trial management is pivotal to your site’s success. Download our eBook to examine several challenges you may face as you conduct research, and how a clinical trial management system (CMTS) can address them.

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