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Tuesday, June 25 • 2:00pm - 3:15pm
#256: Wearables and Patient Technologies Utilized in Clinical Trials

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-623-L04-P; CME 1.25; IACET 1.25; RN 1.25

Explore an initiative which seeks to facilitate and accelerate progression towards a future where patients have access to innovative technologies that enhance the patient experience and reduce their burden in clinical trials. Describe lessons learned from 3 "smart" trials executed for top 5 pharma companies. Explore the use of technology, devices, and virtual visits in a pediatric clinical trial setting and help to alleviate some of the questions and concerns sponsors and regulators have when endpoints or key outcome measures come from personal devices, wearables, or other patient controlled technology.

Learning Objectives

Define opportunities and challenges with use of patient-facing technology in clinical trials; Discuss how to complement eClinical platform with new technologies; Demonstrate how technology and virtual visits are being utilized to ease burden of participation and increase compliance.


Margareth Dimitrov-Kuhl, MA


Patient-Driven Digital Platform: The Need to Integrate eClinical Technologies, Wearables, RPA, and AI/Machine Learning
Isabelle M de Zegher, DrMed, MD, MS, MSc

Making Pediatric Clinical Trials Fun (and Easy?): Virtualization, Wearables, and Other Technologies Utilized in Clinical Trials
Gina Calarco, BSN, MPH

Implementing Patient-Facing Technology in Clinical Trials: How to Overcome the Industry’s Greatest Challenges
Margareth Dimitrov-Kuhl, MA

avatar for Gina Calarco

Gina Calarco

Director of Pediatric Strategy and Planning, Covance
Gina Calarco is Director of Operational Strategy and Planning for the Rare Disease and Pediatric Team at Covance. She is a nurse and received her MPH from the University of Kansas. She is an affiliate member of the American Academy of Pediatrics Section on Advances in Therapeutics... Read More →

Margareth Dimitrov-Kuhl

Clinical Development Function Head, Novartis Pharmaceutical
Margareth Dimitrov-Kuhl is a Clinical Director Function Head at Novartis Pharmaceuticals. She is also a Sponsor-company representative serving on TransCelerate BioPharma’s Patient Technology Initiative focused on developing tools for study teams utilizing patient-facing technologies... Read More →
avatar for Isabelle de Zegher

Isabelle de Zegher

Vice President, PAREXEL Informatics
Isabelle de Zegher is Vice President, Integrated Solutions at PAREXEL Informatics where she is responsible for engineering strategy around Big Data, BI and Advanced Analytics. She has 25 years’ experience in Life Sciences, including extensive work on cross-industry forum on integration... Read More →

Tuesday June 25, 2019 2:00pm - 3:15pm
Room 10 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA