An approach for managing clinical trial applications using semantic information models

Abstract

The management of clinical trial applications by public authorities is a complex process involving several regulations, actors, and IT systems. In this paper we present a modeling approach based on semantic information models that supports this process. In particular, the approach can be used for the generation of user-centric visualizations, performance and compliance analyses and the distribution of the contained knowledge within an organization and to third parties. The approach has been developed together with AGES PharmMed and applied to their core processes. © 2010 Springer-Verlag.