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).