MassMEDIC MedDev Data Capture COVID-19 Webcast

Watch On Demand

Reconsidering Trial Design for Medical Device Companies to Ensure Data Capture in the Challenging COVID-19 Era

COVID-19 has forced a reckoning in how we conduct all aspects of our lives, and clinical trials are no exception. Patient safety is the foundational principle of any trial, and suddenly we have a situation where having patients come into clinical sites for their scheduled visits poses a significant risk to their health and well being.

Trials are having to rapidly adjust how they are structured and how data is being captured, sometimes in the middle of ongoing studies. This is accelerating conversations that have been ongoing in the industry for years, with the power of shifting study tasks into the safety of the patient’s own home becoming starkly evident.

This on demand webinar shares Medidata’s perspective on how clinical trials will be affected in the short term, as the industry rapidly attempts to manage the crisis caused by COVID-19, but also the long term view of how the landscape will be changed by the increased use of technology in trials and the move to trial virtualization.

The webinar covers:

  • Considerations for adjusting data collection strategies in the middle of ongoing studies
  • Trial virtualization and how the move to decentralization will only accelerate in a post COVID-19

Featured Speakers

Michael Tucker
Senior mHealth Product Specialist

Michael is a member of Medidata’s Mobile Health team and is a subject matter expert in electronic informed consent and virtual trials. Over the last six years, Michael has worked collaboratively with sponsors, CROs, regulators, ethics committees and researchers around the world to pioneer the use of electronic informed consent and virtual trials. His 30-year career in medical research includes 8 years with the US government conducting and supporting surgical research and 22 years working in the commercial sector to provide technology solutions that improve and support preclinical and clinical research. Michael has been a participant in two clinical trials…but had to consent on paper because eConsent had not been invented yet! Michael is a decorated veteran of the United States Navy and resides in Austin, Texas where he is an elected public official, serving his local community.

Paul O’Donohoe
Scientific Lead, eCOA and Mobile Health

Paul O’Donohoe is Scientific Lead, eCOA and Mobile Health at Medidata Solutions, a clinical software platform provider. He is responsible for developing the company’s scientific expertise for electronic clinical outcome assessments and mobile health, and is responsible for ensuring internal teams, partners and Sponsors are following industry, regulatory and scientific best practices when it comes to integrating technology into clinical trials. He is passionate about developing the field of eCOA and mobile health through research and active involvement in industry consortia, and is currently the Industry Vice-Director of the C-Path ePRO Consortium.

Previously, Paul worked as a research psychologist at a child and adolescent mental health clinic based in Dublin, Ireland. He moved into the health consulting field with United BioSource Corporation where he worked across the health outcomes, health economics and health data capture groups. Prior to Medidata, Paul was Director of Health Outcomes at CRF Health, an eCOA provider, where he led their health outcomes team. He has a MSc in Cognitive and Clinical Neuroscience.