In this free webinar, learn how adaptive protocols can enable medical device sponsors to merge Phase II and Phase III objectives into a single trial, saving precious time and budget. Attendees will learn how to rigorously screen patients and successfully train them remotely on device use and data collection. The featured speakers will discuss how virtual site teams can keep participants engaged while also ensuring electronic patient-reported outcome compliance.
TORONTO, March 6, 2024 /PRNewswire-PRWeb/ -- Why test a medical device in-clinic when patients will have to manage its use on their own from home?
This question directed Mi-Helper, Inc. Founder and CEO, Steve Schaefer, toward a digital clinical trial design for his migraine medical device. The resulting trial journey, which he assumed would be relatively linear, was anything but that. He had to figure out how to keep his participants engaged during a long run-in period and ensure they used his device properly at home. Resolving this complexity was essential for him to feel confident he would get the pristine data needed for regulatory submissions.
This webinar will focus on the design and deployment of a remote medical device trial. The trial's sponsor, members of the study's clinical operations team and an expert neurologist will provide a 360° view of the challenges associated with conducting medical device clinical trials. Panelists will also reveal how collaboration and iteration helped to identify and mitigate many of the study's risks from the outset.
The attendees will get to learn more about the fundamentals of this clinical trial's success: i) meticulous study design, ii) a comprehensive patient training program and iii) a real-human virtual site team that supported patients and kept them on track throughout their clinical trial journey.
Register for this webinar today to gain insights into designing digital clinical trials for medical devices and related challenges.
Join moderator Florence Mowlem, PhD, VP of Science, ObvioHealth; and panelists Steve Schaefer, Chief Executive Officer, Mi-Helper, Inc.; Matty Lynch, Chief Operations Officer, ObvioHealth; and Larry Charleston IV, MD MSc FAHS, Professor, Department of Neurology, Michigan State University, and Co-Founder, Chief Consultant, and CEO, Charleston Health Neurology & Head Pain Consultants, PLLC, for the live webinar on Monday, March 25, 2024, at 10am EDT (3pm CET/EU-Central).
For more information, or to register for this event, visit Digital Clinical Trials: Avoiding Pitfalls with Intelligent Study Design.
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