Start-Up Strategies for Medical Device Trials

is being presented by Amy Wise, Clinical Research Manager, with PharmaNet Development Group and airs on Wednesday, June 16th, 2010. For more details or to register for this event, please visit our website at www.fxconferences.com

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.

Considering Human Factors in Designing Medical Device Trials

Increasingly, FDA is requiring that clinical evaluations take into account human factors and their effects on device design. It is becoming more important to address how these affect the safety, performance and reliability of medical device use to ensure appropriate device design. Evaluating the human interface in the user environment produces critical data for pre-market applications to FDA. However, medical device trials intending to collect these unique data must be carefully designed to bring the most valuable data to light.

In this audio conference the speaker looks at various human factors which must be taken into consideration when designing a medical device clinical trial, and uses a series of real-life examples to illustrate how best to incorporate them into the design process. In addition, all attendees will receive a copy of Pleiad's Human Factors Considerations checklist.

Considering Human Factors in Designing Medical Device Trials was presented by Annette Valles-Sukkar, Senior Manager, Clinical Operations, with Pleiad Devices and aired on 2009-05-07. For more details or to download this event, please visit our site at www.fxconferences.com