chapter  4
16 Pages

Risk Management Nermeen Varawalla,PRA International,UK

This chapter presents some of the key challenges and assumptions related to managing performance when working with contract research organisation (CROs). In the context of pharmaceutical outsourcing, performance management provides a framework by which both sponsor and CRO can assess performance against the above criteria, understand reasons for variance and trigger remedial action where needed. Performance management begins very early in the outsourcing process. Where a formal relationship has been or is being established for the first time, the performance management approach should be detailed in the relationship documents. One of the difficulties in managing performance is the selection of a performance management tool that is appropriate for the business context. Implementing a new performance management system is always a challenge. Implementation of a system or tool that needs to work across organisational boundaries causes additional issues that need to be fully understood and factored into the plan.