There have been promising developments to run clinical trials in India. To speed
up the time to obtain permission to run a clinical trial in India, new trial
applications are divided into categories:
- Category A: There is already an approved protocol in one
out of several countries on an approved list. The goal is to approve
category A trials in between 2 and 4 weeks.
- Category B: All other trials are placed in this category
(approval time 6 - 8 weeks).
The quality of the trials performed in India shall be improved
by inspections of the clinical sites, CROs and the pharmaceutical companies
As a result of theses developments, more and more phase 2 and 3 studies are
conducted in India and the respective local CROs expand their activities and
offer services like management of the trial and the data.
On behalf of the European Compliance Academy (ECA)