FDA Issues Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products and Devices

Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or all of the trial-related activities occur at locations other than traditional in-person clinical trial sites, along with the technologies and other offerings that typically support them. Because DCTs enable subjects to participate at locations and through methods that may be more convenient for them, DCTs have the…
By: McDermott Will & Emery
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