Bioequivalence and Bioavailability Forum

❝ Can sponsor be present at CRO site to support or guide the CRO while sponsor's study is getting inspected by USFDA auditors at CRO site?

• the FDA may inspect several studies, and the others may be sponsored by other companies. This would raise confidentiality issues;
  
• it is the sponsor's study which is being inspected, but it is also the CRO. Consequences: the sponsor can only be present if the CRO accepts, and cannot force the CRO to accept, unless there are specific provisions in the contract. The CRO may ask the sponsor representative to leave if questions are more general, for instance relating to business or organisational aspects which are not trial-specific;
  
• as far as I know the FDA investigator will usually tolerate the sponsor's presence at the opening and closing meeting of the inspection, as long as they shut up unless specifically talked to, but may kick them out at any time in between, especially if he feels that the sponsor is interfering in any way with the inspection process, or is trying to influence the responses from the CRO.