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

posted by Helmut Homepage – Vienna, Austria, 2022-05-24 16:35 (44 d 03:00 ago) – Posting: # 23015
Views: 976

Dear Ohlbe,

» 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.

Good point!

» 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.

I was once hired by the potential buyer of a dossier to assess it. I asked for the language. Spanish. Told them that my knowledge goes hardly beyond ¡Hola! ¿Qué hay? Paella, Rioja, cerveza. Answer: Fair enough, that’s fine. OK, business class flight to Barcelona, locked (!) for hours in a room with twenty binders. Funny.

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

Another good point. However, it’s not rocket since, right?

» 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 ?

Possible. Shyte.

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