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PREPARING FOR A BIMO FDA INSPECTION


How to Answer The Call With Confidence

The BIMO investigator’s role is to determine if the sponsor, contract research organization or monitor’s practices and procedures comply with regulations, NOT to attempt to scientifically evaluate the study data or protocol.

To help research sites prepare for BIMO inspections, the FDA provides standard guidance to review, as well as BIMO Inspection Metrics detailing the most common findings by fiscal year. 

Get the whitepaper to learn how sponsors should prepare for BIMO Inspections.

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