Sponsors and CRO selection [GxP / QC / QA]

posted by Ohlbe – France, 2022-05-25 12:53 (648 d 14:46 ago) – Posting: # 23018
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Dear Helmut and ElMaestro,

❝ Remember GVK Bio back in the day? Doable in a spreadshit.


❝ The data are available to the sponsor and potential buyers of the dossier as well.


Well, remember GVK ? According to the ANSM inspection report (document A3, page 3), the whistleblower said that "the switch", as ElMaestro calls it, was done only for some sponsors, who paid the head of the bioanalytical lab to do it. The report does not mention any evidence being found to support this allegation, but that's indeed a possibility.

Overall:

Regards
Ohlbe

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