Large multinational, multicenter trials are increasingly being performed during Phase III of the clinical development of a psychotropic drug to demonstrate the efficacy of the new therapeutic agent in the shortest possible time. The testing of the new drug therapy under a common protocol, foreseeing the combination of clinical data collected across countries for a joint evaluation, is becoming more frequent in drug development. Usually, Sponsors use the services of Contract Research Organisations (CROs) to undertake and manage such large multinational, multicenter trials.

The Sponsor who is setting up large definitive CRO-managed studies with psychotropics may anticipate to encounter issues along the following lines: Psychiatric Practice, Organization and Logistics, Data Integration and Manpower.