Bioequivalence and Bioavailability Forum

Hi all,

This is surely not my field of experience nor interest.

Nevertheless, I have been "colaborating" recently in centralized/risk-based monitoring for phase III trials, by providing the monitoring team with pre-defined reports for them to identify centers and forms to SDV. From my perspective, this approach will be more common and effective in the near future for this kind of trials. As regards to bioequivalence, I don't think this will be the case. I can't see how centralized monitoring can be used in this context. Only in the case of units that have eSource implemented and monitoring will be mostly performed on the data available on the eSource system. But in this case, what is the purpose of monitoring? Wouldn't the data management review and medical review "catch" every issue that a monitor could possibly identify?

Regards,
David