Conflicts of interest (COI) & CRO belong to the pharmaceutical Company (CRO b2Ph [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2022-07-08 12:23 (601 d 12:03 ago) – Posting: # 23115
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Dear Osama!

❝ But let us return to the main topic, should the regulatory authorities refuse the submission and acceptance of BE studies that have been performed in a CRO belonging to the sponsor? are there any references? or are there other opinions other than that?

Unless study trend/result is too much doubtful, regulatory bodies generally does not refuse for submission and acceptance. I believe as a sponsor, the submission of all the studies including failed one is important during such time as it gives impression that sponsor has appropriate formulation which are BE to RLD.

Regards,
Divyen

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