Gain the tools you need to develop a protocol that meets regulatory and marketing needs through inquiries, surveys, and discussions. Developing device protocols that maximize impact while minimizing costs is difficult, and often does not reach the goal of generating data for both. Developing protocols that either meet the needs of both regulatory and marketing, or setting up post market studies that answer these questions, requires both detective and analytic capabilities. Speakers will shed light on the steps required to determine what data needs to be collected to answer these questions, or support the post market surveillance to do so.
Determine what endpoints for Regulatory can do for Marketing
Developing strategies to collect data for marketing claims
Minimizing Sample size to answer both Regulatory and Marketing needs
Director, Clinical Affairs,
VP, Clinical and Regulatory Affairs,
Corindus Vascular Robotics, Inc.
Protocol Development for Device Studies: Optimizing Endpoint Selection for Maximizing Regulatory and Marketing Needs
1.00 - ACRP Credits
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