Site Technology
CTMS
Clinical Trial Management System (CTMS)
A 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. Acting as a hub for research operations, a CTMS simplifies study conduct and improves visibility throughout a site’s research portfolio.
Why Do Sites Need a CTMS?
Research Operations Management
A CTMS 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.
Financial Management
The CTMS 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 compliant billing processes.
Reporting and Analytics
A CTMS also enables sites to easily access data to confidently make strategic decisions. Site leadership can identify trends and problem areas, and leverage actionable insights related to accrual, study activation, and staff 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.
The Most Common CTMS Integrations Include:
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 electronic medical record (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 research and financial teams have access to consistent, up-to-date information on study-related invoice receivables.
Other systems
A CTMS can be linked with other systems throughout a site, including eRegulatory, electronic institutional review board (eIRB), electronic data capture (EDC), participant payments, and more. Some platforms can even be linked to social media platforms to facilitate patient recruitment. Where a CTMS may lack a native integration with these systems, they can sometimes be connected via an Application Programming Interface (API).
Leading the Industry in Clinical Trial Management
A CTMS for Every Organization
The industry’s leading clinical trial management systems, built through collaboration with world-class research sites.
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