Bioanalysis monitoring by sponsor [Bioanalytics]

posted by dshah  – India/United Kingdom, 2021-03-02 17:19 (1085 d 08:29 ago) – Posting: # 22238
Views: 2,193

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
22,899 posts in 4,806 threads, 1,652 registered users;
30 visitors (0 registered, 30 guests [including 7 identified bots]).
Forum time: 01:49 CET (Europe/Vienna)

Statistics is, or should be, about scientific investigation
and how to do it better, but many statisticians believe
it is a branch of mathematics.    George E.P. Box

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