Bioanalysis monitoring by sponsor [Bioanalytics]

posted by dshah – India, 2021-03-02 16:19 (45 d 13:24 ago) – Posting: # 22238
Views: 629

Greetings All!
Generally sponsors does monitoring for clinical phase, but up to how much extent sponsor can monitor ongoing bioanalysis? As per WHO- QA of CRO can decide up to which extent the data can be shared during ongoing analysis, but can sponsor completely monitor the bioanalysis?
In my opinion, sponsor shall not monitor the BA phase as they can influence the analysis and ultimately the study outcome. They may assign thir party for monitoring of BA phase.
Regards,
Dshah

Complete thread:

Activity
 Admin contact
21,419 posts in 4,475 threads, 1,508 registered users;
online 13 (0 registered, 13 guests [including 3 identified bots]).
Forum time: Saturday 06:43 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
HTML5