Updates on Preparing a BIMO Data Package

bimo 12 The FDA Bioresearch Monitoring Program (BIMO) develops guides for inspections of clinical investators, sponsors, and Institutional Review Boards (IRBs). The FDA Office of Scientific. BIMO data is indispensable for pivotal trials that profile the safety and efficacy of a marketing application. Typically, the structure of BIMO submissions remains consistent across

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