Integrated Clinical Trial Management Systems

Several years ago Mousley Consulting wrote an article describing some of the key functions of a Clinical Trial Management System (CTMS). Our premise was that many of the people involved with Clinical Trials knew that Electronic Data Capture (EDC) and Clinical Data Management Systems (CDMSs) are computer systems designed to capture, store, and manage clinical trials data.

However, much less familiar to many people, is the integrated CTMS. In the past, the business requirements expressed as functionalities, found in a CTMS were typically “home-grown”, stand-alone or at best loosely-coupled systems. Systems that hopefully helped clinical project managers and others create, manage and conduct their trials.

With EDC being used in more and more clinical studies, and with the increasing emphasis on the use of portals and dashboards, we are seeing some of the functions of the CTMS tightly integrated with the EDC application. Obviously the conduct and management aspects of trial management lend themselves nicely to being part of a portal or a dashboard.

The planning and resourcing aspects of a CTMS, however, do not lend themselves so readily to the portal environment. Consequently, we feel that much of what we wrote earlier is still very much relevant to trial management of today.

Please click on the icon to see the complete article (PDF).