Part 5: Important Considerations when Shopping for EDC

July 20, 2016

In the fifth part of our series entitled important considerations when shopping for EDC, we will discuss how to confirm that the EDC System can integrate with other systems such as CTMS thereby adding many useful features.

Electronic Data Capture (EDC) has been a big focus for more than a decade. But Electronic Data Capture (EDC) is only one piece of the puzzle.  Many times unresolved problems in clinical trials cause delays, wasted resources, team frustration, and even safety issues. Thus, the industry is turning more of its attention to other systems which can be integrated into EDC that provide additional benefits.  For example, one very important system is called the Clinical Trial Management Systems or (CTMS).  Clinical Trial Management Systems (CTMS) help address issues inherent in the operational side of research, including site performance tracking and management, patient recruitment, resource management, supply chain management and regulatory document management.  Many Biopharma organizations are now starting to realize the potential opportunities that exist with EDC-CTMS integration.  By creating simpler, more value added trip reports in CTMS and having access to real-time data (EDC), CRA’s are able to focus more of their attention on site relationship management activities.  CTMS Systems provide tools for visualizing and solving operational problems on a real-time basis.  When selecting an integrated solution with EDC, it’s important to address how and why a system such as CTMS should be integrated with the EDC System.  Look for formats required by the potential system for the loading of data into the application.  Examine the protocols that are required for data transfer to make sure they are compatible with your other clinical technology.

Next week, we will examine allowing enough time to complete the validation testing.

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