Questions about data manipulation [GxP / QC / QA]

posted by qualityassurance – 2024-04-30 15:55 (49 d 02:54 ago) – Posting: # 23969
Views: 3,277

Hello Helmut,

Thank you for your input.

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.
Of course there are system in place for CRO qualification, checking CRO accreditation (especially EU/USFDA) etc. and also monitoring done by sponsor to assure GCP/GLP and data integrity compliance in the BE study. But in nut shell it is not possible to identify profile duplication with such checkpoints and procedure.
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.

Regards,
QA

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