Overview
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 
Featured
Short Course or Primer
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Oct 21, 2021
Short Course 1: Approaches for Developing Novel Digital Endpoints for Medical Product Development
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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
- 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
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Sonya Eremenco, MA • Executive Director, PRO Consortium
Critical Path Institute, United States -
Jennifer Goldsack, MA, MBA, MS • Chief Executive Officer
Digital Medicine Society (DiMe), United States -
Erin Iturriaga, MSN • Clinical Trials Specialist
National Heart, Lung, and Blood Institute (NHLBI), United States -
Jonathan Andrus, MS • President and Chief Operating Officer
Clinical Research IO (CRIO), United States -
Lindsay Stiles Kehoe, MS • Senior Project Manager
Clinical Trials Transformation Initiative (CTTI), United States -
Bill Byrom, PhD • Vice President, Product Intelligence and Positioning
Signant Health , United Kingdom -
Megan Doyle, JD, MPH • Global Policy Lead, Digital Health, Diagnostics, Oncology
Amgen, United States -
Estelle Haenel, DrSc, PharmD • Medical Director
Kayentis, France -
Jules Mitchel, PhD, MBA • President and CEO
THI Pharma Services, United States -
Paul O'Donohoe, MS, MSc • Senior Director, eCOA Product and Science
Medidata Solutions, United States -
Lauren Oliva, PharmD, RPh • Director, Global Regulatory Policy & Digital Health Policy Lead
Biogen, United States -
Keith Wenzel • Senior Director, Scientific Data Organization
Parexel International, United States -
Anindita Saha • Assistant Director, Digital Health Center of Excellence, CDRH
FDA, United States -
Prem Sreenivasan, PhD • Director
HITLAB, United States
Contact us
Registration Questions?
Preconference Short Courses
Short Course 1: Approaches for Developing Novel Digital Endpoints for Medical Product Development
Additional Information
Sign up to be notified when registration opens for the DIA 2022 Events
Digital Technology in Clinical Trials Resource Kit
