BIMO Inspections Yield 24% Violation Rate In FY 2004; Could QSR Help?
This article was originally published in The Silver Sheet
Executive SummaryCHRONIC COMPLIANCE PROBLEMS IN DEVICE CLINICAL TRIALS have led CDRH bioresearch monitoring chief Marcarelli to consider a new idea: apply the tried and true principles of the manufacturing Quality System Regulation to industry-sponsored clinical research activities. Marcarelli will develop informal recommendations for industry based on the concept, while continuing to crack down on violators through enforcement actions such as premarket review holds and investigator disqualifications. Industry experts offer feedback on using QSR-type tools in trial oversight, with most agreeing that monitoring by device firms could stand to be more rigorous
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