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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.

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