Digital Documents for Clinical Trials
March 18, 2014 | Terry Sharrer
It’s worth knowing that before long the FDA will require drug makers to submit their clinical trial documents electronically. This, too, means that researchers and clinical providers will have to do likewise following FDA protocols. The typical Trail Master File contains 25,000 documents and electronic files and cloud access means that regulatory review will be possible any time, any place, any reason. This piece discusses some of the problems that are yet to be overcome with digital documentation, but there’s little doubt this way of doing business will prevail. MORE
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