Clinical Trials with drugs

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

Legal Background: The Clinical Trials Directive (2001/20/EC) 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. The various EU member states have implemented this Directive into laws that apply within each territory separately.

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. This change applies to all clinical trials with medicinal products (i.e. drugs), or any other intervention with the exception of medical devices.

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.