Custom Search

Wednesday, September 10, 2014

Now one can compare regulatory data of requirements for clinical research in different countries

If you are working in clinical research organization and are involved in conducting planning application and approvals for clinical trials here is some good information for you, if you are required to conduct clinical trials are at more than one place or more than one country simultaneously or in break you might be wasting lot of your time in comparing and finding regulations governing clinical trials in those different countries , there are lot of hurdles faced by CRO for registering their clinical trial for approval and so on, as the regulations and rules for clinical trials in different countries are different.

National Institute of Health USA have come up with a very useful portal ClinRegs in order to help in getting such date in one place, where one can compare rules and regulations of two different countries and plan for application and so on.

For example to in USA to file an application for investigation of a new drug through a clinical trial investigator and sponsorer are required to submit investigational new drug application ( INDA ), USFDA reviews the same, while in India Drug controller general review the application, the process at two countries during life cycle of trial and safety reporting, adverse reactions reporting procedures are provided in comparison, which you might find it very useful.
The website in discussion is here http://clinregs.niaid.nih.gov/index.php 

No comments:

Post a Comment

Enter your email address:

Enter your email address: