Biostatistics and Data Management in Global Drug Development

Abstract

Today, pharmaceutical companies want to enter all major markets of the world with their drugs as early as possible and, therefore, perform global development programs that consist of clinical studies conducted in a multinational setting almost all over the world. Usually, several subsidiaries contribute to such a program. International teams are established and assume responsibility for particular tasks within the clinical project. Biostatistics and data management would be handled by a project biometrical team consisting of project and study biostatisticians and data managers. Planning of biostatistics and data management for individual studies and project summaries, generation of standards, smooth and efficient conduct of related activities, and corresponding documentation are their business. As all this becomes increasingly complex and because time must be reduced to a minimum, standardization and workflow management are of great importance. This article will outline the respective steps involved and propose a model of how biostatistics and data management can be approached in global drug development.