Non-interventional studies (NIS)

Non-interventional studies ought to characterize the efficacy of a licensed medicinal product. With respect to the pharmacological characteristics on the one hand, and the increasingly distinct guidelines on the other hand, the appropriate conception is the critical factor for the significance of a NIS.

proinnovera provides planning, conduct and analysis of non-interventional studies on the basis of § 67 para. 6 of the German drug law (AMG).