Novel Applications of Project Management Software to Support the Clinical Development Process in the Pharmaceutical Industry

Abstract

Utilization of computerized project management scheduling systems to plan, monitor and manage the drug development process has become an accepted practice among the majority of pharmaceutical companies. This article discusses a specific application of project management scheduling capabilities within clinical investigation. the concepts are used to monitor individual patients or alternatively to track monthly patient entry numbers within pivotal Phase 111 studies. Report flexibility allows for generating documents for investigator site visits. summarizing patient numbers based on protocol design and projecting available patient numbers for interim statistical analyses.