Dear Prasoon,
The answers to your questions for Europe:
1) A CRO does not need to be approved. However, they will be subject
to GCP inspection by the European national competent authorities.
2) The type of study and number of patients needs to be determined on
a case by case basis. This may need to be evaluated by a statistician
and it may also be prudent to seek scientific advice from the
appropriate European regulatory bodies.
3) The study will be approved by each national competent authority
where the study will be conducted as well as appropriate ethics
committees.
4) The use of data from studies in India will be dependent on the
quality of the study and any pertinent issues, such as
pharmacogenomics, and should be looked at on a case by case basis.
Best regards,
Tim Felgate
Managing Director
Applied Regulatory Consulting Ltd
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