Successful execution of any Phase IV study requires that study processes be streamlined enough to meet the often rapid and commercially-dependent timelines, but rigorous enough to produce data that is rooted in good science and able to stand up to peer review. This balance is often difficult to maintain in the face of changing regulatory and commercial environments.
In this audio conference presentation, the speaker utilizes case studies from recent Phase IV studies to explore what operational strategies worked, what was lacking, and how the CRO/Sponsor relationship was managed.
Executing Phase IV Studies: What Works, What Doesn't was presented by Peggy Schrammel, Vice President Clinical Research, with PharmaNet and aired on 2008-05-29. This conference is available for download at www.fxconferences.com
