Pivotal and pilot BE Study [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2017-07-07 14:05 (2916 d 13:51 ago) – Posting: # 17518
Views: 10,603

Hi K Vishal,

there could be a ton of reasons.

But the one thing I'd check first and above all in exactly this situation is if the right randomization code was applied in the pilot (i.e. was the (single) generated code used for dispensing? Was the code used for stats?

Go onsite to check it yourself. Don't ask the CRO to send you the documentation.

Pass or fail!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,425 posts in 4,928 threads, 1,677 registered users;
40 visitors (0 registered, 40 guests [including 11 identified bots]).
Forum time: 03:56 CEST (Europe/Vienna)

No problem can stand the assault of sustained thinking.    Voltaire

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