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  • 1.  PMA BIMO Information

    This message was posted by a user wishing to remain anonymous
    Posted 09-Aug-2023 14:14
    This message was posted by a user wishing to remain anonymous

    What "BIMO information" does the sponsor need to include in the PMA filing?

  • 2.  RE: PMA BIMO Information

    Posted 10-Aug-2023 04:13


    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: 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.

    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs