Bioresearch Monitoring (BIMO) inspections verify the integrity of clinical trial data supporting your regulatory submissions. FDA scrutinizes every aspect—from informed consent and protocol compliance to data accuracy and investigator conduct. A single BIMO finding can invalidate crucial studies, delay approvals, or trigger broader investigations across your development programs.
BIMO readiness spans multiple stakeholders—sponsors, CROs, clinical sites, laboratories, and IRBs. Each must demonstrate compliant systems, accurate data, and proper oversight. The complexity multiplies with global trials, multiple protocols, and extended timelines where personnel and systems change.
Our BIMO specialists include former FDA investigators who understand both the inspection process and clinical trial operations. We prepare all stakeholders for successful inspections while identifying and remediating vulnerabilities.
BIMO inspection types we prepare you for:
Bioresearch Monitoring inspections focus on verifying the quality and integrity of data submitted to the FDA and confirming proper protection of human subjects. Our approach to mock BIMO inspections recreates the methodical, data-focused nature of these regulatory reviews, examining source documentation, informed consent processes, protocol adherence, and regulatory submissions. We help you identify and address compliance gaps that could impact both inspection outcomes and the credibility of your clinical data.
