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

posted by Ohlbe – France, 2020-02-28 15:23 (1510 d 02:02 ago) – Posting: # 21189
Views: 3,810

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
22,985 posts in 4,823 threads, 1,655 registered users;
43 visitors (0 registered, 43 guests [including 6 identified bots]).
Forum time: 18:25 CEST (Europe/Vienna)

Complex, statistically improbable things are by their nature
more difficult to explain than
simple, statistically probable things.    Richard Dawkins

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