Risk management is an essential part of electronic clinical outcomes assessment (eCOA) planning, especially when it comes to backup and recovery. Although uncommon, device failures can happen. Ensuring data integrity during clinical trials requires viable backup data collection strategies for use in the rare event that assessments can’t be completed with the primary eCOA device.
This free webinar focuses on viable backup solutions that are recognized as industry best practices. Topics include electronic patient-reported outcomes (ePRO) data contingency planning and regulatory considerations. The featured speakers will also discuss web-based data collection processes for site-based and home-based scenarios.
Celeste A. Elash, Director, eCOA Sciences, YPrime
Celeste A. Elash is an eCOA industry expert with deep expertise in instrument development and eCOA solution development and implementation. Throughout her 25-year industry career, Celeste has served as a clinical research scientist, with a variety of contributions for the advancement of patient-focused drug development and eCOA adoption. Prior to joining YPrime, Celeste served as an independent consultant to biopharmaceutical companies and clinical science advisor for two eCOA providers. She currently represents YPrime on the Critical Path Institute’s ePRO Consortium and has contributed to the development of industry best practices for faithful migration of COAs to an electronic platform. In her current position as Director of eCOA Sciences, Celeste is responsible for developing YPrime’s scientific expertise for eCOA and advises biopharmaceutical clients on the implementation of industry and regulatory best practices in studies using eCOA.
Aubrey Llanes, eCOA Product Director, YPrime
Aubrey Llanes guides eCOA product development, using all stakeholder-informed insights across sponsors, sites and patients and evolving industry needs. Her recent experience includes management of global eCOA programs and oversight of the teams responsible for implementation. Drawing from experience across nearly 100 studies, Aubrey brings focused expertise in CNS indications and advanced know-how in all phases of the project lifecycle.
Who Should Attend?
This webinar will appeal to eCOA/ePRO specialists, plus senior professionals working within:
- Clinical Operations
- Data Management
- eClinical Technologies
- Regulatory Affairs
- Outsourcing & Procurement
What You Will Learn
Webinar attendees will learn about:
- Trends in clinical outcome assessments: eCOA
- Data integrity considerations for eCOA contingency planning
- How a web-platform works as a back-up mode of data collection
- Findings and recommendations from the C-Path ePRO Consortium
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.