Integrating Wearable Remote Biosensor Technology into Decentralized Clinical Trials

How do you move from concept to reality? The idea of using wearables in clinical trials has many theoretical advantages.¹ But how does one successfully integrate this burgeoning technology into contemporary clinical research?

In this webinar, Medpace, a global CRO with a specialized remote biosensor team, and Vivalink, a provider of digital healthcare solutions for remote patient monitoring, will guide the audience past the concepts and into the reality of deploying remote biosensor technology to support decentralized and hybrid clinical trials. Join us as these experts share critical considerations and lessons learned in the integration and application of wearable devices into decentralized clinical trials (DCTs).

Endpoints are the starting point for selecting the appropriate wearable devices for a DCT. Device logistics, participant compliance and monitoring, present specific challenges for global trials using wearable devices. Online data capture using secure data streams with defined time periods for acquisition, review and possible safety alert notifications are also important. Visualization, analysis and harmonization of remote biosensor data streams with the clinical trial database are essential elements for successful integration of wearable devices into the DCT design. Finally, traceability and audit trials are just as critical in DCT as in conventional clinical trials designs.

These topics will be addressed and demonstrated in the context of case studies using continuous electrocardiogram (ECG) monitoring in a DCT for digital biomarkers in atrial fibrillation, continuous multi-vitals cardiopulmonary assessment in a DCT for pulmonary hypertension and multi-vital biomarker in a DCT for neutropenic fever.

Register for this webinar to learn best practices for using remote biosensor technology in DCTs.

1. Wearable Biosensor Technology: Transforming Clinical Trials with Remote Data Collection

Speakers

Richard Lee, MD, Senior Medical Director, Medical Department, Medpace

Dr. Richard S. Lee is a board-certified cardiothoracic surgeon with an extensive background in a full range of adult cardiac surgery, including valve repair and replacement, coronary artery bypass grafting, aortic aneurysm surgery, surgery for atrial fibrillation, and transcatheter aortic valve replacement. Dr. Lee graduated summa cum laude from Yale University with a degree in Molecular Biophysics and Biochemistry. After graduating, he earned his medical degree, cum laude, from Harvard Medical School in Boston Massachusetts. He completed a residency in general surgery at Massachusetts General Hospital as well as a residency in cardiothoracic surgery from Stanford University Medical Center in California. He has extensive research experience in transplantation immunology. Dr. Lee has been board certified in cardiothoracic surgery since 2007.

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Salvatore Zabbatino, MD, Senior Director, Core Laboratories, Medpace

Dr. Salvatore Zabbatino has over 30 years of experience in pharmaceutical and device clinical research. He has been a part of the Medpace leadership team since its founding in 1992, serving as Director in key departments. Dr. Zabbatino has held leadership roles across a number of areas, including clinical operations, regulatory, medical writing, biometrics/data management, IT, imaging, and cardiovascular services. He focuses on integrating and optimizing the clinical, operational and technical aspects needed to conduct multinational studies across multiple therapeutic indications. Dr. Zabbatino has extensive experience with imaging and other biomarkers of drug and device safety and efficacy in clinical trials, including DXA (BMD and TBC), Cardiac Echo, Cardiac SPECT, Ultrasound, MR, CT, endoscopy, photography, ECG, Holter and ABPM.

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Mariel Fabro, Head of Products, Vivalink

Mariel specializes in emerging medical technologies, disease management solutions, and accelerating first-generation products to market. Her product principles blend biomedical innovation with technology infrastructure to solve unmet needs in healthcare. Mariel’s previous leadership roles were in R&D, Clinical, and Clinical Marketing for early-stage medical device companies, including Ancora Heart (venture-backed clinical stage), and LumenR (acquired by Boston Scientific). She is a co-inventor on 39 issued patents, spanning cardiology, vascular surgery, neurosurgery, general surgery, and women’s health. Mariel holds BS and MS degrees in Biomechanical Engineering from Stanford University.

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