Questions about data manipulation [GxP / QC / QA]

posted by qualityassurance – 2024-04-30 15:55 (20 d 14:46 ago) – Posting: # 23969
Views: 1,845

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

Complete thread:

UA Flag
Activity
 Admin contact
23,033 posts in 4,835 threads, 1,647 registered users;
48 visitors (0 registered, 48 guests [including 5 identified bots]).
Forum time: 06:41 CEST (Europe/Vienna)

Give me a fruitful error any time, full of seeds, bursting with its own corrections.
You can keep your sterile truth for yourself.    Vilfredo Pareto

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5