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BE/BA centers [Study As­sess­ment]

posted by Helmut Homepage - Vienna, Austria, 2018-07-16 18:51  - Posting: # 19070
Views: 327

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
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