Bioanalysis monitoring by sponsor [Bioanalytics]

posted by dshah  – India/United Kingdom, 2021-03-02 17:19 (706 d 21:47 ago) – Posting: # 22238
Views: 1,889

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:

UA Flag
Activity
 Admin contact
22,485 posts in 4,710 threads, 1,603 registered users;
23 visitors (0 registered, 23 guests [including 7 identified bots]).
Forum time: 15:07 CET (Europe/Vienna)

The difference between a surrogate and a true endpoint
is like the difference between a cheque and cash.
You can get the cheque earlier but then,
of course, it might bounce.    Stephen Senn

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