Auditor NDA/CDA [GxP / QC / QA]

posted by dshah  – India/United Kingdom, 2021-03-16 07:29 (1130 d 15:14 ago) – Posting: # 22268
Views: 2,020

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
22,988 posts in 4,825 threads, 1,657 registered users;
106 visitors (0 registered, 106 guests [including 4 identified bots]).
Forum time: 23:44 CEST (Europe/Vienna)

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity.    Voltaire

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