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Audio conference highlights

A number of elements can influence decision-making when developing a global footprint within the clinical research environment. These elements include: knowledge of the regulatory framework and timelines, suitability of the healthcare setting, compatibility of standard of care, interest within the physician community, internal resource availability to train sites and monitor high quality data, and the competitive landscape.

In this presentation, Dr. Stansfield discusses these elements, with a primary focus on the ways that patient access can influence the successful outcome of clinical research for a new product. She also highlights the pros and cons of different approaches.

This audio conference covers:

• Quality – enhancing patient evaluability and data quality
• Time - maximizing site recruitment months
• Value– considerations of cost base vs. effort required
• Medical and cultural influences on expectations and opportunities for given geographic regions
• Getting the timing right with respect to growth

About the speaker:

Susan C. Stansfield, Ph.D., is Executive Vice President, Product Registration – Europe, Africa and Asia-Pacific with PRA International. Before joining PRA Dr. Stansfield served as Senior Vice President, Project Management and Clinical Operations, Europe with Pharmaceutical Product Development, Inc. (PPD). Under her leadership, the European operations achieved substantial increases in revenue, gross profit and operating margin.

Dr. Stansfield has also held senior management positions at Quintiles and Innovex, where she was responsible for business process improvement, leading the operational services across Europe and managing full-service clinical research projects. She began her career in clinical research in various positions with the Wellcome Research Foundation, the Janssen Research Foundation and Parke Davis

Dr. Stansfield earned a B.Sc. in Physiology and Biochemistry from Nottingham University, and a Ph.D. in Neuropharmacology from Reading University.

Who should attend?

• Heads of R&D
• VPs Clinical Development
• Directors of Clinical Operations
• Program and Clinical Study Managers
• Directors of Outsourcing and Procurement
• VPs Global Data Management

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.