Sponsors and CRO selection [GxP / QC / QA]

posted by Ohlbe – France, 2022-05-25 12:53 (758 d 12:51 ago) – Posting: # 23018
Views: 4,338

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

Complete thread:

UA Flag
Activity
 Admin contact
23,059 posts in 4,841 threads, 1,663 registered users;
39 visitors (0 registered, 39 guests [including 7 identified bots]).
Forum time: 01:45 CEST (Europe/Vienna)

[…] an inappropriate study design is incapable of answering
a research question, no matter how careful the subsequent
methodology, conduct, analysis, and interpretation:
Flawless execution of a flawed design achieves nothing worthwhile.    J. Rick Turner

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5