The U.S. Food and Drug Administration's Bioresearch Monitoring (BIMO) program is a comprehensive portfolio of mechanisms designed to assess and monitor all aspects of the conduct of FDA-regulated research to assure human subject protections and the quality and integrity of data submitted to FDA. Despite the Trump Administration's emphasis on deregulatory themes in its messaging to the public and industry, BIMO activity continues to demonstrate steady enforcement, particularly in the Good Clinical Practice (GCP) space. Sponsors, contract research organizations (CROs), and investigators should remain vigilant as inspection expectations evolve and FDA continues its scrutiny of GCP compliance fundamentals.

FDA's BIMO program encompasses onsite inspections, data audits, and remote regulatory assessments to monitor the activities of clinical investigators, sponsors, CROs, Institutional Review Boards (IRBs), nonclinical laboratories, and postmarketing reporting systems.

The total number of BIMO inspections conducted has rebounded since 2020, rising from around 650 in FY-2021 to over 1,000 in FY-2024 and FY-2025 to date. Notwithstanding the change in administrations, FDA's enforcement activity continued unabated in 2025. As in prior years, clinical investigator inspections have traditionally made up the bulk of BIMO inspections compared to inspections of sponsors, CROs, IRBs, and nonclinical testing facilities governed by FDA's Good Laboratory Practice (GLP) regulations.

Consistent with historical patterns, clinical investigators remain the most frequent targets of BIMO warning letters, with all 10 letters issued in 2025 directed at investigators. FDA continues to cite investigators for protocol deviations, poor recordkeeping and documentation activities, informed consent deficiencies, and monitoring and oversight failures.

FDA has not signaled any intention of reducing its GCP and GLP inspection or enforcement emphasis in the near term, and sponsors should expect BIMO inspections to remain an active part of regulatory oversight in 2026 and beyond. These trends continue to highlight the necessity of sponsors taking all appropriate steps to ensure high levels of quality and compliance in their clinical and preclinical studies, including robust monitoring and auditing programs to identify potential GCP and GLP compliance risks as early as possible. Maintaining inspection readiness also remains critical to protecting marketing applications from preventable delays.