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.

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CDMS and EDC Design Highlights

Over the years Mousley Consulting has published a number of articles with EDC-related topics. This was done as a founding partner of EDC Management. We believe that it makes sense to periodically revisit some of these topics and update our thinking when necessary. One of the topics we wrote about was CDMS Design Highlights. A CDMS is a Clinical Data Management System which is used by data management departments in Biopharma to collect, clean and store clinical trial data.

CDMS and Electronic Data Capture (EDC) applications suffer when the underlying repository (i.e., database) doesn’t offer data types that support the convenient storage of clinical trials-specific data. Clearly Data Capture Form Developers and Programmers spend much time developing code (and much of it redundant nature) to support the different clinical data types such as "Partial Dates". If this support were built into the repository, form developers and programmers would have a much easier time providing necessary clinical trial-specific functionality, and could more quickly make data entry forms available for users saving both time and money.

We believe that future versions of CDMS and EDC software should include the "clinical data types" that are discussed in our article. However, we understand that the design and implementation of these data types will be a challenging exercise for vendors. Certainly, there will be different ways the support for these data types can be developed and introduced. The best implementations will balance ease of programming with the required functionality.

Readers are encouraged to share recommendations that they may have for how vendors can improve their products. We would also like to encourage feedback and suggestions regarding this article, and welcome suggestions of topics.

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