This webinar is a forward-looking panel discussion featuring industry experts that will explore multiple perspectives for advancing electronic clinical outcome assessments (eCOA) adoption, including areas of increased regulatory consideration, evolving eCOA technology, functionality and the shift to mHealth.

The discussion will include:

  • eCOA trends and emerging capabilities
  • New technology that provides convenience and flexibility
  • Regulatory matters

Speakers

Kenneth Grice, eCOA Strategist, Data Acquisition Services, Bayer

Ken Grice is the eCOA Strategist at Bayer. Having spent 20 years of his career supporting various aspects of electronic data capture, Ken currently oversees strategy, implementation, and operational aspects of eCOA. As technology and processes evolve to collect additional data directly from patients, Ken is interested in leveraging the knowledge he has gained from eCOA implementation to successfully build infrastructure and processes for high quality patient engagement, direct data capture from wearables and sensors, and clinical trial support for patients.

Message Presenter

Jonathan Helfgott, Faculty/Coordinator, Regulatory Sciences and Food Safety Programs, Johns Hopkins University

Jonathan S. Helfgott is currently the Executive Director of Global Regulatory/Clinical Affairs & Market Access at Stage 2 Innovations and Faculty/Coordinator for the Regulatory Science & Food Safety Graduate Programs at Johns Hopkins University. Prior to joining Stage 2 Innovations in early 2015, Jonathan was the Associate Director for Risk Science, within the Office of Scientific Investigations at FDA’s Center for Drug Evaluation & Research (CDER).  Prior to joining CDER in 2010, Jonathan worked at the FDA’s Center for Devices and Radiological Health (CDRH) within the Division of Bioresearch Monitoring (BIMO). Jonathan received his M.S. in Bioscience Regulatory Affairs from Johns Hopkins University and his B.S. in Cell Biology and Molecular Genetics from the University of Maryland College Park.

Message Presenter

Donna Mongiello, RN, BSN, Vice President, Strategic Solutions, YPrime

Donna Mongiello is Vice President, Strategic Solutions for YPrime. Bringing twenty years of business development and operational leadership in eClinical and digital health solutions, she is a recognized expert in patient recruitment, retention and eCOA topics.

Donna’s nursing background and industry career supporting sponsors have instilled a strong desire to improve clinical research from the patient’s perspective, simplify study conduct and make study participation less burdensome for patients.

Message Presenter

Lisa Henderson, Editorial Director for Applied Clinical Trials and Pharmaceutical Executive

Lisa Henderson is Editorial Director for Applied Clinical Trials and Pharmaceutical Executive. She has over 20 years of experience in business-to-business publishing, covering a variety of industries including clinical trials, managed healthcare and information technology. In addition to her own educational and thought-provoking writing and speaking engagements, Henderson leads a team of experienced journalists in producing content that stimulates discussion about how to move beyond the status quo.

Message Presenter

Who Should Attend?

  • ePRO / ePRO Category / Data Managers
  • Clinical Trial / Clinical Study Leads
  • Therapeutic Strategy Leads
  • Clinical Operations Specialists
  • Clinical Operations Directors / VPs

What You Will Learn

The discussion will include:

  • eCOA trends and emerging capabilities
  • New technology that provides convenience and flexibility
  • Regulatory matters

Xtalks Partner

YPrime

YPrime offers more than a decade of focused work with eclinical systems to expedite and improve the quality of patient management, clinical supplies, drug accountability and clinical data. Cloud-based interactive response technology (IRT) and electronic clinical outcome assessment (eCOA) platforms offer sponsors greater speed, precision and integration in clinical trial management.

Our data services and tools help sponsors bring together fragmented clinical research data into contextual information they can act on. YPrime’s technology and service offerings enable sponsors to move faster and more efficiently to their next development milestone.

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