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As clinical trial sponsors find increased opportunities for decentralized and hybrid trials, Digital Health Technologies and Connected Devices are taking on a larger and more critical role and helping to drive the ability to collect remote data directly from patients.
In this webinar, IQVIA Connected Devices leaders Jen Ohme and Jessica Ekey discuss the framework of the new FDA Guidance on Digital Health Technologies and how to practically apply it to your clinical trial device selection. In addition to reviewing the key takeaways in the draft guidance, they also highlight important and practical considerations needed to identify suitable devices that meet your clinical endpoint requirements and validation approach.
Watch now to explore this pressing topic and discover how you can expertly navigate the important decision of device and technology selection for your clinical trial. Discover the role expert guidance and support can play in ensuring your remote patient data drives better decisions and trial execution.
Key points covered include:
• Review of FDA draft Guidance on Digital Health Technologies
• Key considerations when making device selections
• Practical examples of device and health technology solutions and the impact on clinical endpoints
Director, Connected Devices Strategic Solutions
Jessica has over 15 years’ experience in the clinical trial industry, including 10+ years at IQVIA. As the Connected Devices Strategic Solutions Lead for Cardiology and Respiratory Solutions at IQVIA, Jessica Ekey is responsible for selecting and onboarding new device technologies as part of IQVIA’s device portfolio and building custom solutions for clients’ unique trial needs.
Prior to working with IQVIA’s Connected Devices, Jessica worked with Phase I sites specializing in onboarding eSource technology and device integrations to enable cleaner and quicker trial data directly from the source. She holds a Bachelor of Science in Biology from Washburn University, and a Master of Business Administration from the University of Kansas.
Strategy Solutions Lead
As a Strategic Solutions Lead within the Connected Devices team at IQVIA Jen Ohme is responsible for developing the strategy and design requirements for device driven data collection. She is focused on actigraphy, vitals and blood pressure devices. Jen has supported the medical, pharmaceutical and CRO industry over the past 19+ years. Her previous roles have included working in product management, project management and client services.
Prior to joining IQVIA in 2019, Jen worked at a CRO leading their IRT Services department and has 16+ years in the eClinical Healthcare Technology arena. She holds a Bachelor of Arts from the University of Minnesota and a Masters of Business Administration from Augsburg College (Minnesota).
Managing Editor, Content Writer
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