The start-up phase of any clinical trial is a hectic time, but there are several areas that require additional consideration and planning for medical device trials. The primary goals of the start-up phase are to distribute and collect documentation to approve each site for the initiation visit so enrollment can begin. However, additonal support and planning is needed by sponsors/CROs for device trials to assist sites with specific tasks such as medicare approval; device shipment, storage, and accountability; planning for maintenance of a blind; and documentation of staff training on the investigational device.

This audio conference discusses how proactive planning and timely responsiveness to site requests can help make the start-up phase for medical device studies more efficient, and can lay the foundation for a positive relationship with the sites that will continue through the life of the study.

This audio conference covers:

• Additional issues to consider with start-up of medical device studies
• Medicare approval overview
• Medical device shipment, storage, and accountability considerations
• Blind planning and maintenance
• Device training requirements for study staff

About the speaker:

Amy Wise, PhD. received her doctorate from Baylor College of Medicine in Houston, TX in 1998 in Molecular and Human Genetics. She has been involved in the conduct of clinical trials for over nine years with a strong focus in medical device project management and clinical monitoring. She has served as the project manager on over 17 medical device studies, including cardiac stents, electrocardiology devices, spinal implants for degenerative disc disease, auto immune diseases, gastroparesis, and peripheral vascular stents.

Who should attend?

• Clinical Operations Directors
• Clinical Project Managers & Project Leaders
• Clinical Research Associates
• Regulatory Affairs