FDA Guidance on Clinical Systems

The FDA has drafted a new version of its Guidance for Industry – Computerized Systems Used in Clinical Trials. Explore Consulting has created a side-by-side comparison of the old and new versions with a summary of changes so that you can more clearly understand the changing FDA perspective on this topic.

 

Steve Griggs presented this paper at the October 2004 meeting of the Northwest Clinical Data Management Users Group.

 

Explore Consulting offers regulatory compliance consulting services for Life Science companies.

 

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