New Art. 31 referral: suspected data manipulation again [GxP / QC / QA]

posted by Ohlbe – France, 2020-02-28 14:23  – Posting: # 21189
Views: 1,025

Dear all,

A new Article 31 referral has been announced on the EMA web site. It looks like another CRO has been caught manipulating data to make a failing study pass. More details in the referral notification.

Regards
Ohlbe

Complete thread:

Activity
 Admin contact
20,458 posts in 4,296 threads, 1,414 registered users;
online 5 (0 registered, 5 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 19:09 CEST

Genius is that which forces
the inertia of humanity to learn.    Henri Bergson

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