Blind monitors or greedy sponsors? [GxP / QC / QA]

posted by Ohlbe – France, 2022-05-24 14:21 (44 d 04:20 ago) – Posting: # 23014
Views: 995

Dear Helmut,

» also interesting the list of medicines concerned by the procedure. You can read it ‘backwards’, i.e., look at the sponsors.

Well, marketing authorisation holders / applicants were not necessarily the sponsor of the study. Some of them just bought the dossier off the shelf, before or after the marketing authorisation was granted. Due diligence: generally, nil, especially if the marketing authorisation was already granted. EMA organised a workshop with representatives of the generic drug industry some years ago, after the first referrals of this type. Nothing came out of it. Industry's position: "we can't audit the study when we buy the dossier coz' we were not the sponsor". It went nowhere.

» Given that, were monitors of the other sponsors :blind: or just greedy?

Or just incompetent ? Or were some of the sponsors perfectly aware of the scam, and willing to use such CROs precisely because they were sure their study would pass ?


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