Auditor NDA/CDA [GxP / QC / QA]

posted by dshah – India, 2021-03-16 06:29 (31 d 23:38 ago) – Posting: # 22268
Views: 313

Hi ElMaestro!
So if we have a CDA with Sponsor and CRO, weather can we consider as independent auditor?
And then what is the purpose of monitoring if we can't share observation with even sponsor?
Why Sponsor wants to go ahead with such CRO only?
Can we raise a concern with Regulatory body about demand of CRO and its implications?
The CDA demand by CRO is totally unacceptable.

Complete thread:

 Admin contact
21,419 posts in 4,475 threads, 1,508 registered users;
online 13 (0 registered, 13 guests [including 5 identified bots]).
Forum time: Saturday 07:08 CEST (Europe/Vienna)

I never did anything worth doing by accident,
nor did any of my inventions come by accident;
they came by work.    Thomas Alva Edison

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