The Association of Clinical Research Professionals

Protocol Development for Device Studies: Optimizing Endpoint Selection for Maximizing Regulatory and Marketing Needs

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.


This program is a recorded session from ACRP 2018