Tag: IRB oversight FDA inspections

FDA Bioresearch Monitoring (BIMO) Inspections in U.S. Clinical Trials: What Sponsors Should Expect Navigating FDA BIMO Inspections in U.S. Clinical Trials: Expectations and Best Practices Introduction The Bioresearch Monitoring Program (BIMO) is the cornerstone of the FDA’s oversight of clinical trials in the United States. Designed to ensure the protection of human subjects and the…

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