A Brief Overview of the FDA Bioresearch Monitoring (BIMO)

bimo 12At the start of preparing a BIMO data package, we collected and organized all necessary data and documentation required for the BIMO data package. We set up a checklist, which comprisedthe study team should discuss these items with FDA prior to starting BIMO programming activities. 2. In order to avoid any last-minute snags while preparing the BIMO package, it is