Role of effective project management in reducing drug development cost

Abstract

Pharmaceuticals are passing through the difficult phase due to increasing numbers of patents expiry along with increasing cost of drug development. Protocol design, regulatory cycle time, site selection, patient enrollment and monitoring are some of the cost contributing elements for late phase clinical trials. This paper applies the principles of project management and suggests means to reduce the cost of late phase drug development. It also throws light on the critical role that a project manager can play in overall drug development process.