Auditor NDA/CDA [GxP / QC / QA]

posted by dshah  – India/United Kingdom, 2021-03-16 07:29 (629 d 14:25 ago) – Posting: # 22268
Views: 1,281

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
22,428 posts in 4,694 threads, 1,598 registered users;
20 visitors (0 registered, 20 guests [including 16 identified bots]).
Forum time: 21:54 CET (Europe/Vienna)

Statistics is the art of never having to say you’re wrong.
Variance is what any two statisticians are at.    C.J. Bradfield

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