Legal/authorized representation

KCRI is fully set up to act, and has been providing the service of legal/authorised representation to out-of-EU Sponsors for their clinical trials on the entire EEA territory.

Sponsors from outside European Union  (e. g. from USA, Israel, Japan, China, India) wishing to conduct clinical trials in the European Economic Area (EEA) are obliged by the EU Clinical Trial Directive 2001/20/EC to be represented by a legal entity with a place of business in European Union. For any given clinical study, there must be only one representative for one sponsor in one clinical trial. As a representative, KCRI is ensuring the compliance of the trial with the Directive and acts as an agent of the sponsor in any legal proceedings.