Digital Technology in Clinical Trials

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Overview

As a direct and sole result of the outbreak of the coronavirus disease (COVID-19) and due to circumstances beyond our control, DIA announced that it has decided to change the format of the upcoming Digitial Technology in Clinical Trials meeting from “face-to-face” (in-person) to entirely virtual.

For more information, please review the list of Frequently Asked Questions.

NEW CONFERENCE

Digital technology is transforming the drug development process. The rise of wearable and mobile technologies along with cloud technology, Artificial Intelligence and related platforms, now enable the collection of frequent, specific, and multidimensional data throughout the length of trials. These technologies have the potential to enable innovative trial designs, improve the patient experience, act as recruitment and retention tools, and establish novel end points in clinical studies.

With these technologies, large amounts of data are collected. How to best address evaluating fit-for-purpose, standardization, ethical concerns, and regulatory approaches, are key issues to address in the digital era.

DIA’s Digital Technology in Clinical Trials Conference will bring together thought leaders from regulatory agencies, biotech, pharma, patients, and academia to discuss the latest advances, challenges, and forward-thinking approaches for implementing digital technology to improve clinical trials. While the conference will focus on the impact of digitalization in clinical trials today, we will make time to explore future applications and how they may enable the clinical trials of tomorrow.

Co-Sponsored with ePRO Consortium – Critical Path Institute

On Demand Content Preview Webinar:

So, My Fitbit is Clinical Trial Grade, Right?

The promise of wearables and sensor data includes collecting data that demonstrates new investigational products are safe and efficacious and/or that fewer site visits are required; thus, making clinical trials more efficient, less intrusive, and less expensive. This presentation will break down the elements of wearables selection, evaluation, and inclusion in clinical trials, allowing you to better understand the support structure required for wearable sensor use. This presentation will also touch on integration touch points between wearables and other eClinical systems.

Learn More

The program has been released! Preview all session descriptions, speakers, and more all in one place!

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Who should attend?

Executive, Leadership, and Management Professionals from Biotechnology, Pharmaceutical, Device, CRO, Regulatory Agency, and Academic Research Sponsors involved in:

Business Development
Clinical Trial Design and Development
Study Endpoint Development
Clinical Research, Operations, Site Selection, and Management
Research and Development
Clinical Monitoring and Oversight
Quality Management
Contracts Management
Clinical Data Management
Data and Biostatistical Sciences
Health Economics and Outcomes Research
eClinical Technology and Solutions
Digital Strategies and Technologies
Data Analytics, Strategy, and Technology
Information Technology, Systems, and Programming
Regulatory Affairs
Patient Engagement, Recruitment, and Retention
Patient Advocacy, Partnerships, and Services
Legal and Compliance
Ethics, IRBs
Medical Affairs and Communications

Learning objectives

At the end of this conference participants should be able to:

Articulate and evaluate applications of digital technologies in clinical trials to: improve patient experience, ensure that trial endpoints are clinically meaningful and represent improved patient outcomes, improve trial design, facilitate the conduct and operation of clinical trials, and facilitate the collection and use of quality data for clinical study and regulatory decision-making
Describe related policy, legal, scientific, and regulatory concerns
Discuss the evolving roles, skills, and qualifications of medical product professionals in the application and use of these technologies in clinical trials

Program Committee

Paul O'Donohoe, MS, MSc • Scientific Lead, eCOA and Mobile Health
Medidata Solutions, United States
Sonya Eremenco, MA • Associate Director, PRO Consortium, and Acting Director, ePRO Consortium
Critical Path Institute, United States
Lauren Oliva, PharmD, RPh • New Technologies Global Regulatory Policy Lead
Biogen, United States
Keith Wenzel • Senior Director, Scientific Data Organization
Parexel International, United States
Julie Dietrich, MS • Vice President, Clinical Operations
Genfit Corp, United States
Harlan M. Krumholz, MD • Harold H. Hines, Jr. Prof of Medicine and Director, Center for Outcomes Research
Yale University, United States
Jonathan Raymond Andrus, MS • Chief Business Officer
Clinical Ink, United States
Jennifer Goldsack, MA, MBA, MS • Executive Director
Digital Medicine Society (DiMe), United States
Jules T Mitchel • President
Target Health LLC, United States
J. Jason Lundy, PhD • Principal
Outcometrix, United States
Paul Upham • Head, Smart Devices
Genentech, A Member of the Roche Group, United States
Kristen Valdes • Founder and Chief Executive Officer
B.Well Connected Health, United States
Dan Tierno, MA, MBA • Associate Director, Project and Portfolio Management
Daiichi Sankyo, Inc, United States