Auditor NDA/CDA [GxP / QC / QA]

posted by dshah  – India, 2021-03-16 07:29 (1572 d 13:50 ago) – Posting: # 22268
Views: 3,868

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.
Regards,
Dshah

Complete thread:

UA Flag
Activity
 Admin contact
23,427 posts in 4,929 threads, 1,685 registered users;
37 visitors (0 registered, 37 guests [including 10 identified bots]).
Forum time: 22:20 CEST (Europe/Vienna)

In the field of observation,
chance favors only the mind that is prepared.    Louis Pasteur

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