Tuesday, on February 13 in Orlando, Florida, FSR’s Executive Director Ginger Spitzer will be presenting again at the Summit for Clinical Ops Executives (SCOPE) with one of FSR’s industry partners. Focusing on non-interventional studies are an integral part of product development plans, and Ginger will be discussing FSR’s involvement in these types of studies and projects. Her presentation with occur within SCOPE’s Cambridge Healthtech Institute’s 7th Annual Late Stage Research and Observational Studies: Novel Approaches and Data Sources for Post-Approval Research conference designed to facilitate knowledge exchange around all aspects of observational research from the designing and managing of post-approval studies, to applying the obtained data to pivotal business and medical decisions.
The presentation by Ginger and her co-host Winne Nelson from Mallinckrodt will focus on the valuable role of non-profit disease research foundations in securing and managing real world data and collaboration with industry to access the data. The two-part presentation will include review of methods such as patient registries, clinical site networks, collaboration, wearables, and other techniques, and will feature the perspective of industry partners as both collaborators and first-line collectors of data. The “neutral third party” status of the non-profit organizations can enable industry to navigate more easily the issues in logistics to get direct real world data. Spitzer’s presentation revolved around the Foundation for Sarcoidosis Research’s Sarcoidosis Advanced Registry for Cures (FSR-SARC) Patient Registry.
About the Event
The 9th Annual SCOPE Summit, taking place February 12-15, 2018 in Orlando, FL, will offer four stimulating days of in-depth discussions in 18 different conferences, 3 plenary keynote sessions, and the ever-popular interactive breakout discussions focused on advances and innovative solutions in all aspects of clinical trial planning, management and operations: Site Selection and Management, Patient Engagement, Recruitment and Retention, Protocol Optimization, Feasibility, Data Strategy & Analytics, Sensors and Wearables, Project Management, Outsourcing, Forecasting, Resource Management and Capacity Planning, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Artificial Intelligence (AI), Post-Marketing Studies, Observational Research, Clinical Supply Chain, and Precision Medicine.