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Overview

Short Course: March 29
Conference: March 30-31

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?
February 26 | 12:00-1:00PM

This talk will give an overview of recent FDA efforts in the area of Complex Innovative Clinical Trial Designs (CID). Topics covered will include FDA’s final guidance on Adaptive Design Clinical Trials for Drugs and Biologics, FDA’s draft guidance on Interacting with FDA on Complex Innovative Trial Designs, and the FDA pilot review program for CID. The webinar will serve as a preview for the upcoming 3/2/20 – 3/3/20 DIA workshop “Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients".

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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

Program Committee

  • Paul  O'Donohoe, MS
    Paul O'Donohoe, MS Scientific Lead, eCOA and Mobile Health
    Medidata Solutions, United States
  • Sonya L. Eremenco, MA
    Sonya L. Eremenco, MA Associate Director, PRO Consortium, and Acting Director, ePRO Consortium
    Critical Path Institute, United States
  • Lauren  Oliva, PharmD, RPh
    Lauren Oliva, PharmD, RPh Global Regulatory Policy Lead, New Technologies
    Biogen, United States
  • Keith  Wenzel
    Keith Wenzel Senior Director, Scientific Data Organization
    Parexel, 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. Professor of Medicine and Director CORE
    Yale University, United States
  • Jonathan Raymond Andrus, PhD, MBA, MS
    Jonathan Raymond Andrus, PhD, MBA, MS Chief Business Officer
    Clinical Ink, United States
  • Doug  Peddicord, PhD
    Doug Peddicord, PhD Executive Director
    Association of Clinical Research Organizations (ACRO), United States
  • Casey  Orvin
    Casey Orvin President
    Society for Clinical Research Sites, United States
  • Jennifer  Goldsack, MA, MBA, MS
    Jennifer Goldsack, MA, MBA, MS Executive Director
    Digital Medicine Society (DiMe), United States
  • Jules T Mitchel, PhD, MBA
    Jules T Mitchel, PhD, MBA 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
  • Matthew  Diamond, MD, PhD
    Matthew Diamond, MD, PhD Medical Officer, Digital Health, Office of the Center Director, CDRH
    FDA, United States
  • Adria  Martig, PhD
    Adria Martig, PhD Senior Director, Research Programs
    Parkinson's Foundation, United States
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Contact us

Registration Questions?

Send Email
1.888.257.6457


Preconference Short Courses

A Primer on Digital Biomarkers and Measurement in the Connected Era

Short Course 1: eCOA 101: The What, Why, and How of eCOA to Reduce Barriers to Adoption in Clinical Studies


Additional Information

Digital Technology in Clinical Trials Resource Kit


On Demand Content Preview Webinar

So, My Fitbit is Clinical Trial Grade, Right?
February 26 | 12:00-1:00PM


Register Today!


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