The Co-Sponsor in the conduct of a Clinical Trial in Germany

The sponsor is highly relevant in the conduct of clinical trials, both from a financial point of view and in terms of responsibility for study management. Until now, only one sponsor was designated as the primary contact for the conduct of clinical trials. The new regulation (EU) No 536/2014 allows the use of multiple sponsors, so-called co-sponsors. But this also raises new problems and questions for existing contracts and new contracts between sponsors, especially regarding the liability of one or more co-sponsors in the external as well as the internal relationship. This article highlights the issues arising from this amendment and clarifies the differences between a sponsor and a co-sponsor.