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Overview

Short Course | October 11

Conference | October 13-14

The DIA’s Digital Technology in Clinical Trials Conference discovers how digital technology is transforming the drug, device, and diagnostics development process in clinical trials.

Join thought leaders from regulatory agencies, biotech, pharma, patients, and academia to discuss the latest advances, challenges, and forward-thinking approaches in the field.

Registered attendees will receive access to all session recordings for 2 full months post-conference! This allows you to remain flexible with your schedule and not worry if you need to miss a session. Have a conflict with the dates of the conference? Register anyway and you will receive access to the recordings!

This Program is Co-Sponsored with Critical Path Institute’s eCOA Consortium

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Members of the Electronic Clinical Outcome Assessment (eCOA) Consortium are firms that provide electronic data collection technologies and services for capturing COA data in clinical trials. The eCOA Consortium provides a pre-competitive environment in which a critical mass of experts can collaborate to generate measurement equivalence data, develop specification documents and data standards, and provide guidance on methodological considerations related to eCOA applications. All of these activities are aimed at enhancing the quality, practicality and acceptability of electronic capture of clinical trial endpoint data.



  • Event Goals and Offerings

    • Discuss digitalization in clinical trials of today
    • Explore future applications enabling clinical trials of tomorrow
    • Strategize implementation methods to innovate trial designs, improve patient experience, utilize recruitment/retention tools, and establish end points
    • Address industry changes created by the introduction of:
      • Wearable and mobile technologies along with cloud technology
      • Artificial intelligence and related platforms enabling timely data collection and analysis
      • Potential of multidimensional data throughout the length of trials

      View Agenda



  • Why You Can’t Miss It

    • Identify traditional and technological approaches to clinical trials and acknowledge their advantages and disadvantages
    • Discuss how advanced analytics are transforming the ability to understand and utilize data
    • Examine regulatory needs and roadblocks of digital technology
    • Explore how wearables and other digital modalities are allowing for diversity in trials and research
    • Recognize ethical issues in integrating digital technology to clinical trials
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  • Learning Objectives

    At the conclusion of this activity, participants should be able to:

    • Identify best practices in planning and executing decentralized trials and assess the challenges that remain for broad scale decentralized trial adoption
    • Discuss the role of regulators in addressing DHT during the review process and describe how to bridge modern technology with current and past regulations
    • Discuss how relationships with sites and trial participants are integral to digital health technology implementation success
    • Explain the main gaps in current regulatory expectations in the United States (US) and European Union (EU) as of today and evaluate different resources that can supplement existing regulatory guidance and help to inform globally harmonized guidelines
    • Describe the regulatory concerns or requirements for using AI and ML in clinical trials
    • Identify opportunities and constraints in improving the patient experience using digital health technology in clinical trials and recognize the value of patient input by prioritizing patient preferences and priorities in the development and design of study protocols, deploying DHTs, and collecting data


  • Meeting Designed For

    • Digital Strategies and Technologies
    • (e)Clinical Technology and Solutions
    • Clinical Site Management and Operations
    • Business & Data Development, Strategy, and Analysis
    • Patient Advocacy, Engagement, and Recruitment
    • Compliance & Regulatory Affairs
    • Ethics, Health Economics & Endpoint Development
    • Security, IT, Systems, and Programming
    • Medical Affairs & Communications
    • R&D and Quality Management
    • Register Now



Participant Testimonials

If you are working with digitalization in the clinical trial area I found it very interesting to explore and gain more insights, trends and best practice sharing which will help me to improve our digital strategy

Program Committee

  • Megan  Doyle, JD, MPH
    Megan Doyle, JD, MPH Global Policy Lead, Digital Health, Diagnostics, Oncology, & Combination Product
    Amgen, United States
  • Jonathan  Andrus, MS
    Jonathan Andrus, MS President and Chief Operating Officer
    Clinical Research IO (CRIO), United States
  • Rachel  Chasse, MS
    Rachel Chasse, MS Digital Operations Lead
    AbbVie, United States
  • Elena  Izmailova, PhD
    Elena Izmailova, PhD Chief Scientific Officer
    Koneksa, United States
  • Scottie  Kern
    Scottie Kern Executive Director, eCOA Consortium
    Critical Path Institute, United Kingdom
  • Sarah  Krug, MS
    Sarah Krug, MS Chief Executive Officer
    CANCER101, United States
  • Jules  Mitchel, PhD, MBA
    Jules Mitchel, PhD, MBA President and CEO
    THI Pharma Services, United States
  • Steven  Murray, PhD
    Steven Murray, PhD Group Vice President and Principal Engineer, Electrical and Data Sciences
    Exponent, United States
  • Lauren  Oliva, PharmD, RPh
    Lauren Oliva, PharmD, RPh Director, Global Regulatory Policy & Digital Health Policy Lead
    Biogen, United States
  • Shelly  Steele
    Shelly Steele Senior Scientific Advisor, eCOA
    WCG Clinical Endpoint Solutions, United States
  • Keith  Wenzel
    Keith Wenzel Senior Director, Scientific Data Organization
    Parexel International, United States
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