The FDA’s Bioresearch Monitoring (BIMO) program is more than just inspections—it’s a regulatory safeguard for the rights and welfare of clinical trial participants and the integrity of data used to support FDA submissions. In this episode, we break down the scope and function of the BIMO program, explore common findings during inspections, and discuss practical strategies for maintaining continuous inspection readiness.
Learn how sponsors, CROs, investigators, IRBs, and testing labs can stay ahead of the curve with proper documentation, monitoring, and mock audits. Ignoring BIMO findings isn’t just risky—it can delay or derail product approval. Listen in for expert insights and actionable tips to help you navigate the BIMO landscape with confidence.
KGK Science has been delivering top-notch clinical research trials and expert regulatory support for the nutraceutical, cannabis, hemp, and psychedelic industries for over 27 years, aiding companies in bringing their products to global markets with custom trials and claim substantiation strategies.
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