Lexology November 18, 2022
Ankura Consulting Group, LLC

In David Fogel’s published review of 30 years of clinical trial research operations, he sums up the likelihood of study success by saying:

“Clinical trials for pharmaceuticals and medical devices offer many opportunities for failure.”1

In recent years, technological advances are helping streamline clinical trial management processes using clinical trial management systems (CTMSs). The opportunities for failure in research are being minimized by centralized electronic systems ensuring study integrity and subject safety. However, to validate and maintain these E-Systems for clinical research takes a concerted regulatory guidance effort by numerous governing bodies that are currently a project in fluidity as the electronic market continues to blossom and change.

This article will briefly cover regulations that touch on CTMSs...

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