Clinical Trial Management System
A clinical trial management system (CTMS) is responsible for managing all operational aspects of a clinical trial, from study startup to closeout. Research sites, site networks, health systems, academic medical centers, and cancer centers use a CTMS to centralize information related to protocols, subjects, staff, financials and billing, and much more. A CTMS acts as the hub for research operations, simplifying study conduct and improving visibility throughout a site’s research portfolio.
Why Do Sites Need a CTMS?
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Research Operations Management
Allows a site to manage all aspects of research from study activation through closeout, including protocol and accrual information, subject screening and activation, study calendars, and more.
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Financial Management
Provides a site with full visibility into the financial performance of studies across their research portfolio, streamlines the budgeting process, and centralizes billing designation information to ensure billing compliance.
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Reporting and Analytics
Enables a site to easily access data to confidently make strategic decisions. Sites leadership can identify trends and problem areas, and leverage actionable insights related to accrual, study activation, and effort.
Integrating Throughout the Enterprise
By itself, a CTMS serves a critical purpose in clinical research management. Building on that foundation, sites often integrate their CTMS with other enterprise systems, resulting in improvements to staff efficiency, data quality, and even patient safety.
Here are a few of the most common CTMS integrations:
Protocol and Subject Information: Typically leveraging the IHE HL7 Retrieve Process for Execution (RPE) protocol, this integration sends protocol number, title and principal investigator to an EMR system. Also, subject data can be sent from the CTMS to the EMR so a patient can be flagged within the EMR as an enrolled research participant.
Demographics: A patient demographics interface is used to transfer demographic data such as contact information, patient identifiers, and date of birth from the site’s EMR system to a CTMS. This saves the research organization staff time and reduces room for error when manually entering data.
Protocol Billing Grid: This interface allows study team members to indicate procedure billing designations at the protocol level within the CTMS, which then provides this information to an EMR for use in determining how to route charges. The ultimate goal of this interface is to support billing compliance while centralizing and streamlining communication among study and financial teams.
General Ledger: This receivables interface allows a site to manage the payment of the CTMS-initiated invoice in the general ledger system, and then reconcile the payment for those research activities in the CTMS. Connecting these systems ensures that research and financial teams have access to consistent, up-to-date information on study-related invoice receivables.
Other Research Systems: A CTMS can be linked with other systems throughout a site, including eRegulatory, eIRB, EDC, participant payments, and more. Where a CTMS may lack a native integration with these systems, they can sometimes be connected via an Application Programming Interface (API).
Industry-Leading Clinical Trial Management Systems from Advarra
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Read our Related Resources
Beginner’s Guide to Clinical Trial Management Systems
A clinical trial management system (CTMS) can bring powerful efficiencies, insights, and compliance to sites' day-to-day operations.
Driving Site Efficiency and Visibility Using a CTMS
As clinical trials grow more complex, this eBook reviews how a CTMS may help your organization address challenges as you conduct research.
