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Hyatt Regency Cambridge

Nov 14, 2019 7:30 AM - Nov 15, 2019 12:30 PM

575 Memorial Drive, Cambridge, MA 02139

Real World Evidence Conference

How Real World Evidence can be used for regulatory purposes

Session 4: Incorporating Mobile Technologies into Real World Evidence Studies

Session Chair(s)

Jacqueline A. Corrigan-Curay, JD, MD

Jacqueline A. Corrigan-Curay, JD, MD

Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER)

FDA, United States

Marni  Hall, PhD, MPH

Marni Hall, PhD, MPH

Vice President and General Manager, Global Regulatory Science and Strategy

IQVIA, United States

This session will explore the use of mobile technologies in generating RWE by examining the types of data that can be captured, e.g. patient reported data versus sensor data and trials designs used. Design features of the FDA MyStudies mobile app design and platform will be presented. Opportunities for integrating data from mobile technologies with other RWD sources, such as sensors, will be examined. Regulatory considerations for incorporating mobile technologies into clinical trials and how mobile technologies can facilitate decentralized trial designs and adherence will be discussed.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Define at least two different uses for mobile technology in RWE studies
  • Describe regulatory considerations for use of mobile technology data in RWE studies
  • Discuss at least one regulatory consideration for trial designs using mobile technology


David  Martin, MD, MPH

Incorporating Mobile Technologies into Real World Evidence Studies

David Martin, MD, MPH

Moderna, United States

Vice President, Global Head RWE

Christopher  Ceppi


Christopher Ceppi

Science 37, United States

Chief Product Manager

Pamela  Tenaerts, MD, MBA

Creating a Path for Decentralized Clinical Trials

Pamela Tenaerts, MD, MBA

Medable, United States

Chief Scientific Officer

Norman  Stockbridge, MD, PhD

Practical Experience

Norman Stockbridge, MD, PhD

FDA, United States

Director, Division of Cardiology and Nephrology, OND, CDER

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