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

posted by Helmut Homepage – Vienna, Austria, 2022-05-24 12:51 (82 d 19:29 ago) – Posting: # 23013
Views: 1,235

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 :blind: 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.

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Helmut Schütz

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