Bioresearch Monitoring (BIMO)

Bioresearch Monitoring (BIMO) is a process used by regulatory agencies, like the FDA, to ensure clinical trials for new drugs and medical devices are conducted properly. It involves overseeing research activities to verify they follow legal and scientific standards, protect participants, and generate reliable data. BIMO includes inspections, audits, and reviews of study sites and records to confirm compliance with regulations. This helps ensure that the study results are trustworthy, safe for participants, and meet the necessary quality standards before new medicines or devices are approved for public use.