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Short Course: October 21
Conference: October 27-29

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 Critical Path Institute’s ePRO Consortium


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Highlights & Features

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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:
  • Identify operational challenges arising due to emergence and integration of technology in clinical trials
  • Describe related policy, legal, and regulatory concerns
  • Discuss current digital technology solutions that meet the needs of patients, site staff, and organizations in the conduct of clinical trials
  • Identify gaps where digital technology solutions could be developed to improve patient, clinician, and organizational experience, value, and outcomes
  • Examine use cases or case studies addressing challenges

Program Committee

  • Sonya  Eremenco, MA
    Sonya Eremenco, MA Executive Director, PRO Consortium
    Critical Path Institute, United States
  • Jennifer  Goldsack, MA, MBA, MS
    Jennifer Goldsack, MA, MBA, MS Chief Executive Officer
    Digital Medicine Society (DiMe), United States
  • Erin  Iturriaga, MSN
    Erin Iturriaga, MSN Clinical Trials Specialist
    National Heart, Lung, and Blood Institute (NHLBI), United States
  • Jonathan  Andrus, MS
    Jonathan Andrus, MS President & COO
    CRIO, United States
  • Lindsay Stiles Kehoe, MS
    Lindsay Stiles Kehoe, MS Senior Project Manager
    Clinical Trials Transformation Initiative (CTTI), United States
  • Bill  Byrom, PhD
    Bill Byrom, PhD Principal, eCOA Science
    Signant Health , United Kingdom
  • Megan  Doyle, JD, MPH
    Megan Doyle, JD, MPH Global Policy Lead, Digital Health, Diagnostics, Oncology
    Amgen, United States
  • Estelle  Haenel, DrSc, PharmD
    Estelle Haenel, DrSc, PharmD Medical Director
    Kayentis, France
  • Jules  Mitchel, PhD, MBA
    Jules Mitchel, PhD, MBA President and CEO
    THI Pharma Services, United States
  • Paul  O'Donohoe, MS, MSc
    Paul O'Donohoe, MS, MSc Senior Director, eCOA Product and Science
    Medidata Solutions, United States
  • Lauren  Oliva, PharmD, RPh
    Lauren Oliva, PharmD, RPh Director, Global Regulatory Policy & Digital Health Policy Lead
    Biogen, United States
  • Keith  Wenzel
    Keith Wenzel Volunteer
    DIA Study Endpoints Community, United States
  • Anindita  Saha
    Anindita Saha Assistant Director, Digital Health Center of Excellence, CDRH
    FDA, United States
  • Prem  Sreenivasan, PhD
    Prem Sreenivasan, PhD Director
    HITLAB, United States
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