Stata European Medicines Agency

[Dimi Arv]

Dear All,

I would like to ask for your help/experience.
I know that FDA accepts data analysis performed by Stata.
Do you have any experience with EMA ? I know that in ICH E9 no specific software is described. Is data analyzed by Stata being accepted ?

Thank you very much in advance,

Best regards,

Dimitris

[Leonardo Guizzetti]

As long as you can produce the data submission package in the prescribed format, and likewise the CSR, I don't see why you can't. R and SAS are accepted, but you will overwhelmingly find SAS used by force of momentum, rather than being prescribed.

[Dimi Arv]

Dear Leonardo,

Thank you very much for your response.

Best regards,

Dimitris