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.
This audio conference covers:
- Key drivers of the recent explosion of Phase IV growth
- Why Phase III data is not appealing to the Phase IV audience
- Practical advice for successfully executing Phase IV studies of all size and scope
- Case studies of recent Phase IV studies; what went wrong and why
- How the CRO/pharma relationship should be managed to bring out the best in both parties
About the speakers:
Peggy Schrammel is the Vice President of PharmaNet's Phase IV Development Division, where she oversees a dedicated group of nearly 100 professionals involved in the design and execution of Phase IIIB, Phase IV and patient registry studies. Peggy also has responsibility for PharmaNet's dedicated Endpoint Processing Group and leads a corporate-wide Medical Device initiative.
Prior to her tenure at PharmaNet, Peggy was a Vice President at another major CRO, where she oversaw a late-phase operational group and was later responsible for late-phase study design and business development. Peggy received both her BA and MPA from the University of Pittsburgh and spent several years at Pitt Medical Center conducting community-based mental health research. She is a frequent speaker on various late-phase topics at industry meetings and symposia.
Who should attend?
- Managers & Directors of Medical Affairs
- Outsourcing Manager, Medical Affairs
- Clinical Research Associate, Clinical / Medical Affairs
- Product Managers
- Marketing Managers
- Outcomes Research Professionals
This audio conference is rated General Interest.