Project Management in Pharmaceutical Biometry and Data Management: Conception,Implementation,and Operations

Abstract

Biostatistics and data management are becoming increasingly complex. Patient numbers per study grow larger, authority requirements increase, preclinical activities need increased support, and new technologies need attention and effort. On the other hand, reengineering and improvement programs aimed at cutting costs and accelerating the research and development (R&D) processes are started. In parallel, the number of staff as well as the desired time frame for projects is reduced. To cope with that situation, an attempt is made to increase productivity through new computer technology and organizational measures such as standardization and resource or workflow management. Professional project management provides the instruments to achieve the desired productivity. Once the decision is made to implement project management, special attention should be focused on the selection and education of the project managers, a precise definition of tasks and desired results, and careful implementation in the interdisciplinary R&D environment. This article will outline the respective steps involved and will discuss examples for effective operations.