1. Pink Sheet

FDA Compliance Office Wants To Find Clinical Trial Problems In Time To Correct Them

 
• By Cathy Dombrowski

The agency is seeking a quality-by-design approach to clinical trials so sponsors can identify potential risks to patient safety and trial implementation up-front and take steps to avoid them.

FDA is looking at shifting some of its compliance resources into real-time monitoring of clinical trial quality, both in terms of investigator activities and implementation of the trial plan.

The aim is a more proactive approach that finds deficiencies as they emerge, rather than after they occur, according to...

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