Return on Investment of a Compliant Clinical Data Repository

An accelerating pipeline of drug candidates is emerging from discovery, waiting for efficient and fast evaluation of their pharmacokinetics before they can be pushed through to the next stages of drug development. The ever increasing cost of clinical studies is forcing more elaborate and intensive evaluations of pharmacokinetic (PK) and pharmacodynamic (PD) characteristics at earlier and earlier stages of development. The FDA Critical Path Initiative has called for more use of PK/PD modeling. As a result, leading companies are turning to technology to improve productivity and leverage scarce scientific talent in PK/PD analysis and reporting. This document highlights the return on investment (ROI) of an online PK/PD study data repository.

Typically, companies without PK/PD data repositories operate in a mixed environment, copying Microsoft® Excel® files into Phoenix WinNonlin and storing data and derived parameters on some file system. This makes later archival, retrieval and integration difficult and cooperation with external partners inefficient because data cannot be shared easily. Creating compliant final reports requires extensive manual intervention.