Bioequivalence and Bioavailability Forum • clinical trial mangement tools

martin
★★

Austria,
2015-08-26 17:14
(3158 d 08:23 ago)

Posting: # 15340
Views: 5,698

clinical trial mangement tools [Off Topic]

Dear all,

I would happy to get the opinion from the forum members regarding clinical trial management tools enabling to showing patient information (e.g. example tool).

I think that there is the possibility of unintentional unblinding by using such tools.

For this reason, I would be happy to get your thoughts and experiences (if any) with such tools and ideas how to prevent to bring bias to a study.

Best regards & thank you

Martin

Dr_Dan
★★

Germany,
2015-08-27 17:45
(3157 d 07:52 ago)

@ martin
Posting: # 15360
Views: 4,458

clinical trial mangement tools

Post reply

Dear Martin
I do not think that the members of the forum are the right addressees for your question since such tools were not developed for the generic industry and IMHO these tools provide no advantage in BE/BA. For a solid oral IR formulation you conduct just one BE study and in other cases you may need some more studies but I know nobody in the generic industry who uses such a clinical trial management tool.
Kind regards
Dr_Dan

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Kind regards and have a nice day
Dr_Dan