BE/BA centers [Study Assessment]
Salut Jean-Luc,
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, Chile, 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).
2018-10-16: 1,399
2019-10-05: 1,461
❝ […] 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, Chile, 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).
- As of today 1,386 (!) “medical institutions entitled to conduct clinical trials of medicinal products for medical use” are accredited in Russia (click on and navigate to the last page). Gimme a break.
2018-10-16: 1,399
2019-10-05: 1,461
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- BE/BA centers JLpiccard 2018-07-13 20:35 [Study Assessment]
- BE/BA centers Helmut 2018-07-13 22:42
- BE/BA centers JLpiccard 2018-07-16 18:16
- BE/BA centersHelmut 2018-07-16 18:51
- BE/BA centers JLpiccard 2018-07-16 18:16
- BE/BA centers ElMaestro 2018-07-13 22:42
- BE/BA centers JLpiccard 2018-07-16 18:17
- BE/BA centers Helmut 2018-07-13 22:42