James Gaiser, Associate Director, Statistical Programming, PROMETRIKA, LLC.
Quick – What is BIMO?
Is it a flying superhero? Is it an energy drink? Is it the next reality TV show? (Well, it is reality.) Here is a brief overview of BIMO and how it came to be.
Back in 1977, the FDA was granted the right to audit clinical research sites. To meet this new responsibility, the FDA established the Bioresearch Monitoring (BIMO) Program, which created guidelines for agency inspections of clinical trial sites. Gathering site-level data such as details about the investigator, IRB, subject data, and the site itself, to determine which locations to audit, is a time-consuming task for agency reviewers. As you can imagine, this slows the audit planning and completion process, which, ultimately, slows the review and approval of a new treatment. To improve efficiency, the FDA began to look to sponsors for review aids.Continue reading “Do you BIMO?”