Managing a Full Development Program for an Overseas Client

PPD worked with a Japanese client in the earliest stages of drug development to help bring a product to market. At the time, the client had no U.S. presence. PPD worked with the client to develop the critical clinical protocols and served as the liaison to regulatory authorities.

Over the course of four years, PPD monitored the clinical trials, performed the data management and statistical analyses of pivotal studies, integrated the safety data, set up and participated in FDA meetings and prepared and assembled the new drug application (NDA). Following the submission of the NDA, the product was approved and launched successfully in the U.S.