Making the right decision about where to conduct Phase I of a clinical trial is crucial. As long as basic EU regulatory requirements are fulfilled, the investigational site may be located anywhere in the world. This paper will walk you through the three key essential considerations for clinical trials intended to support registration in the EU. (We’ve focused on bioequivalence studies, but most of the considerations discussed apply to other Phase I trials as well.) Areas covered include ethical standards and good clinical practice, trial design and conduct, and local requirements.