BE/BA centers [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2018-07-16 18:51  – Posting: # 19070
Views: 1,402

Salut Jean-Luc,

» […] i saw in different Agencies that they publish a list of approved CRO for BA/BE.

Where? As ElMaestro wrote, the WHO maintains a list of inspected sites.
On the other hand, navigate to the FDA’s Clinical Investigator Inspection Search and select Country IND (India). Gives me 61 hits and none of the well-known CROs.
“Approved CRO” is a term often misunderstood. There are a few countries certifying CROs (e.g., Brazil, Turkey, Russia). You can only hope that a CRO (generally a study / studies) was inspected by a reputable* agency. This means that on the date of inspection these studies were performed according to the rules of GCP. Doesn’t mean that all are or will be in the future (yes, yours!)…
Another story is GLP. Under its rules the site is inspected and the certificate is valid for 2–3 years (depending on the issuing authority).



Cheers,
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,514 posts in 4,141 threads, 1,336 registered users;
online 9 (0 registered, 9 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 21:11 CEST

I have not failed 700 times. I have not failed once.
I have succeeded in proving
that those 700 ways will not work.    Thomas Alva Edison

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5