Bioequivalence and Bioavailability Forum • Blind monitors or greedy sponsors?

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

posted by Helmut – Vienna, Austria, 2022-05-24 14:51 (1048 d 04:32 ago) – Posting: # 23013
Views: 8,403

Hi ElMaestro,

also interesting the list of medicines concerned by the procedure. You can read it ‘backwards’, i.e., look at the sponsors. No pre-study vendor audit, sloppy monitoring? Yeah, on-site monitoring generally covers only the clinical part but still…

Once we were there for a monitoring. The analytical part was performed somewhere else and hence, mix-up of samples not an issue. Luckily it was only a pilot study for a couple of new formulations to be used in a line-extension. The reference performed exactly as expected but the others terrible → waste container.
However, during the monitoring we felt uncomfortable. No smoking gun but dried blood on tissue paper in the phlebotomy room (before the study started!), contradicting statements about handling the IMPs, etc.
I recommended my clients to avoid this CRO.

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

Edit: Discovered a goody.

Successful Completion of Surprise Joint Audit by USFDA & WHO – 18 – 22 November 2019

Another proof of our impeccable regulatory track record. We are pleased to announce the successful completion of Surprise Joint Audit by USFDA & WHO. The Audit lasted for 1 week. A Huge Thank You and Congratulations to our wonderful dedicated teams for their commitment and continual focus on quality. Without them this would not have been possible.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

Another two... Ohlbe 2021-09-16 23:41
- 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 selection Ohlbe 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