What "BIMO information" does the sponsor need to include in the PMA filing? <o:p></o:p>
Information concerning Bioresearch Monitoring (BIMO) of a clinical study typically includes information how the Sponsor is conducting their own monitoring of the study including site monitoring, data monitoring (if applicable), regulatory adherence, etc. Typically this would include any planned monitoring which would be during different steps of the process including site qualification, site monitoring, adverse event evaluation, data analysis review, and even site close-out. This can also include references to any internal procedures which the company has (and should have) concerning clinical investigation monitoring for how this would be performed. In my experience when providing this information, I would try to mimic what would be expected by an FDA BIMO inspection: https://www.fda.gov/medical-devices/premarket-approval-pma/pma-clinical-studies#bioresearch. It does not necessarily need to be in great detail, but an overview. I have found the information about BIMO monitoring in the PMA submission is "well established" then it helps to minimise future BIMO inspections by FDA.
Regulatory Affairs Professionals Society (RAPS)5635 Fishers Lane, Suite 400Rockville, Maryland 20852
email@example.com+1 301 770 2920
JoinMy RAPS DashboardLearn More