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Virtual

Nov 19, 2024 12:00 PM - Nov 19, 2024 1:00 PM

Inclusivity as a Part of Feasibility: Making Trials More Representative with RWD

The RWD that optimizes study design and fuels feasibility can also support diversity. Discover how RWD can support new FDA draft guidance for Diversity Action Plans.

Presenters

Tracy Lou Ohrt, MS, PMP

Tracy Lou Ohrt, MS, PMP

Director, Clinical Operations, Digital Research Network, Optum Life Sciences, Clinical Trial Solutions, United States

Tracy Ohrt oversees clinical operations and research projects within the DRN, liaising with life science customers and healthcare organizations to support study feasibility, site identification, and data acquisition. She collaborates with clinical data teams to develop feasibility results, patient-finding lists, and study databases. Tracy ensures research projects align with clinical strategy, budget, and regulations while proactively managing study risks. Before joining DRN in 2019, she oversaw clinical trials at the University of Wisconsin, Madison. Tracy holds a BS in biology and psychology, an MS in biomedical sciences, and certifications in project management and clinical research.

Jenny  Higley, MS

Jenny Higley, MS

Director, Head of Feasibility CoE, Biogen, United States

Jenny Higley is an accomplished professional with 18 years of experience in clinical research and strategy development. Currently serving as the Director and Head of the Feasibility Center of Excellence at Biogen, Jenny excels in leading early planning feasibility processes and ensuring alignment of roles and responsibilities across internal and external partners. With a strong focus on innovative approaches and data-driven strategies, Jenny has significantly enhanced operational efficiencies and optimized clinical trial protocols throughout the drug development process.

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