Questions about data manipulation [GxP / QC / QA]

posted by Helmut Homepage – Vienna, Austria, 2024-04-30 16:52 (20 d 12:58 ago) – Posting: # 23970
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Hi QA,

❝ In this case there is always Sword of Damocles hanging over the sponsor head for their dossier because it can be affected by manipulation in another sponsor's BE study.

Correct. This was the case in the Synapse story. AFAIK, some companies tried to support their arguments by software. None was accepted and they remained on the hook. Only one sponsor succeeded to get off the list. No idea how they did it. There were also cases where the reference is no more on the market and therefore, it’s no possible to repeat a study. Bad luck.

❝ […] But in nut shell it is not possible to identify profile duplication with such checkpoints and procedure.

Correct. The only possibility I can think of is that the sponsor hires a team (‼) of monitors which is 24/7 at the site. Yep, get camp beds and sleeping bags. Be present at all phases of the study (clinical, analytical, data transfer, statistics). :-D
Don’t think that this was ever done.

❝ There should be availability of some robust system (may be regulators should come forward) which prevents the risk of sponsor (often pharma companies) and common man (using the approved medicines) and at the same time CROs not involved in such practices would be benefited.

You’re an optimist. Regulators will never share such information (i.e., tell who are the bad and good guys).

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