Bioequivalence and Bioavailability Forum

Dear Dshah,

The bioanalytical part of the study is just as important as the clinical part and should deserve just as much QC and QA efforts from the sponsor as the clinical part. Therefore having the sponsor monitor or audit bioanalysis is, in itself, not a problem and I would actually encourage a better sponsor oversight.

What could be discussed is whether the monitoring or audit could take place in-process or only once activities are completed. However if you have processes in place with robust SOPs and stick to them, and make clear to the sponsor representatives in advance that they shall not try and influence in any way e.g. the acceptance of analytical runs or the re-analysis of certain samples, but only check compliance with GCP, GLP and your SOPs, it should be feasible. Still, I would recommend never to leave the sponsor representative alone with junior staff and to ensure there is always somebody there with enough authority to resist undue sponsor pressure.