Site Challenges & Solutions

With the trials IMARC has monitored, our experience has been that the FDA has begun inspecting clinical sites after the Sponsor submits their Premarket Approval Application (PMA), the application submitted to the FDA for approval of a Class III device.

In this case, however, the FDA contacted one of the sites for a routine inspection months before the PMA was to be submitted. The site inspected was among the top enrollers in this particular study, and was an academic medical center. We've recorded some of the challenges from this case study in the download provided.