Clinical Trials with drugs

For Clinical Trials in the EU please contact FGK-RS B.V.  

Legal Background: Article 74 (1) of Regulation (EU) 536/2014 on Clinical Trials requires that for all clinical drug trials in the EU a sponsor or a legal representative of the sponsor must be legally registered within the European Economic Area: “Such legal representative shall be responsible for ensuring compliance with the sponsor's obligations pursuant to this Regulation, and shall be the addressee for all communications with the sponsor provided for in this Regulation”.

For Clinical Trials in Switzerland please contact FGK-RS AG

Legal Background: Article 2 (d) of the “Ordinance on clinical trials with the exception of clinical investigation with medical devices” demands that a sponsor not established in Switzerland has to assign a representative based in Switzerland.
The official explanation document to the above-mentioned ordinance asks for the representative of the sponsor for a clinical trial to be the contact point for the Swiss authorities and ethics committees when communicating with the sponsor.

In addition, the “Ordinance on human research with the exception of clinical trials” requests for cases in which the sponsor (and not the investigator) is responsible for the organization of the human research projects which are not clinical trials, for the sponsor to be established in Switzerland or to nominate a Swiss representative.