Clinical Research

One of our law firm’s specialist fields is compliance with the statutory requirements when pharmaceuticals and medical devices are tested on human beings. We have many years of experience in the implementation of clinical trials with pharmaceuticals and medical devices and with the realisation of other biomedical research projects involving human beings.

There are ethical, medical and legal boundaries, which must be observed (in particular, good clinical practice – GCP), checked and approved by competent authorities and ethics committees. Our expertise encompasses all forms of cooperation within the framework of clinical research in academic institutions and with investigators and study centres, sponsors, contract manufacturers and contract research organisations (CROs).

One focal point of our advisory activities concerns contract management between the respective cooperation partners (investigator contracts, CRO contracts, manufacturing contracts, subsidy and cooperation agreements) in German and English.