Data Management Team-Driven Approach to Handling International Clinical Data

Abstract

Wellcome manages clinical research programs through two administrative centers: Beckenham, UK, and Research Triangle Park, NC, USA. Clinical trials within a drug development program may be conducted solely through a single administrative center or internationally in support of regulatory submissions. We have developed an approach to managing clinical trial data that facilitates the exchange and merging of international data bases for regulatory submissions. Our data management team approach focuses on an intensive up-front review and agreement of data collection goals for a clinical program. This focus is sustained throughout the life of the program. Our approach facilitates data pooling across protocols for analysis and reporting and reduces the magnitude of that effort without regard to the systems that are used. This paper reviews the features of our approach.