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

posted by Ohlbe – France, 2020-02-28 15:23 (1490 d 17:03 ago) – Posting: # 21189
Views: 3,736

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:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
84 visitors (0 registered, 84 guests [including 5 identified bots]).
Forum time: 08:26 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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