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Session 6 Track A: Paperless Clinical Trials During the Time of COVID-19 and Beyond
Session Chair(s)
Jules Mitchel, PhD, MBA
President and CEO
THI Pharma Services, United States
Estelle Haenel, DrSc, PharmD
Medical Director
Kayentis, France
Direct data capture has been involved since decades now, and the COVID-19 pandemic acted as a catalyst to accelerate further digital developments in clinical trials. The session will investigate all aspects of the direct data capture paradigm, including the improvement of data quality, time to data review, time to database lock, and quality of life of all the ones involved (patients, sites, caregivers…).
The goal is also to interact with the session participants, have them share their experiences in modern-day approaches to clinical trials, explore added value for every clinical trial stakeholder, and start to address standards for direct data capture.
Learning Objective : At the conclusion of this session, participants should be able to:
- Learn how the paperless clinical trial can change the clinical trial paradigm
- Understand how direct data capture improves data quality
- Assess the value for all the ones engaged in the data capture
Speaker(s)
Introduction to the Paperless Trial & Regulatory Perspectives
Jules Mitchel, PhD, MBA
THI Pharma Services, United States
President and CEO
Telemedicine in Clinical Trials Paves the Way for Paperless Trials
Bryan McDowell, MBA, MSc
Clario, Switzerland
Vice President, eCOA Clinical Science and Consulting
Introducing Additional Perspectives to Paperless Clinical Trials
Estelle Haenel, DrSc, PharmD
Kayentis, France
Medical Director
How and Why do Paper-Removing Technologies Help Patients, Sites, Caregivers, Medical Experts and Others Running Clinical Trials
Sheila Khawaja, MA
World Alliance of Pituitary Organizations, Italy
Patient Engament Expert| EURORDIS Alumni; Board Chair