Bioequivalence and Bioavailability Forum • Sponsors and CRO selection

Sponsors and CRO selection [GxP / QC / QA]

posted by Ohlbe – France, 2022-05-25 12:53 (1117 d 14:15 ago) – Posting: # 23018
Views: 11,638

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:

if the sponsor selected the CRO precisely because it is doing "the switch" (be the decision to select that CRO or to make "the switch" made by the Man in the Penguin Armani Suit or by somebody not willing to bring bad news to this man), well...
if not: I agree with ElMaestro that "the switch" is extremely unlikely to be detected on-site during a monitoring visit or study-specific audit, and that looking into the data is most likely to be the only way to detect it. But I also agree with Helmut: CROs doing "the switch" are probably not the best on the market, and there are a number of "warning bells" which should have rung during a proper site selection audit or during monitoring visits. I once talked to a regulatory inspector who told me of inspections where he just wanted to run away after half a day, having just done a tour of the facilities and a couple of discussions with staff, and was wondering how anybody with a sane mind could have contracted such people.

—
Regards
Ohlbe

Complete thread:

Another two... Ohlbe 2021-09-16 23:41 [GxP / QC / QA]
- Another two... ElMaestro 2021-09-17 08:42
  - Dates Ohlbe 2021-09-17 10:15
  - Some more info Ohlbe 2021-09-17 20:28
    - EU Article 31 referral started Ohlbe 2022-01-24 17:47
- Cheating Helmut 2021-09-17 16:50
  - Increased variability Ohlbe 2021-09-17 17:56
    - Increased variability ElMaestro 2021-09-17 18:51
      - Visualization Helmut 2021-09-18 15:26
- Another two... jag009 2021-09-19 09:18
- Another two... ElMaestro 2022-05-24 12:00
  - Blind monitors or greedy sponsors? Helmut 2022-05-24 12:51
    - Blind monitors or greedy sponsors? Ohlbe 2022-05-24 14:21
      - Blind monitors or greedy sponsors? Helmut 2022-05-24 16:35
    - Blind monitors or greedy sponsors? ElMaestro 2022-05-25 08:11
      - (Cumulative) T/R-ratio vs. time Helmut 2022-05-25 09:19
        
        Sponsors and CRO selectionOhlbe 2022-05-25 10:53
        
        I still think that T/R-ratios are useful Helmut 2022-05-25 12:04
        
        T/R-ratios are useful Ohlbe 2022-05-25 14:40
        
        T/R-ratios are useful Helmut 2022-05-25 15:35
        Bust the Buster Helmut 2022-05-26 15:32
        
        complicate the assessor's life mittyri 2022-05-26 18:28
        
        complicate the assessor's life PharmCat 2022-05-27 09:57
        complicate the assessor's life Helmut 2022-05-27 10:11
        
        Thanks for Busting the Buster sameep 2022-05-31 08:34
        
        Thanks for Busting the Buster Helmut 2022-05-31 15:22
        
        A small point for the code sameep 2022-06-01 13:17
        
        A small point for the code Helmut 2022-06-01 14:11