Thursday, May 8, 2025 | 12:00-1:00PM EST
As drug development becomes more complex and personalized, traditional randomized controlled trials (RCTs) are no longer sufficient to answer every research question—particularly in rare diseases, and situations lacking head-to-head comparisons. Regulators, payers and other stakeholders are increasingly turning to real-world evidence (RWE) to address the gaps, but concerns around data quality, fit-for-purpose study design, and regulatory acceptance remain.
This webinar will explore the challenges of using real-world data (RWD) in observational studies, and show how life sciences teams are leveraging automation and AI to accelerate development timelines, reduce burden on sites and patients, and generate high-quality, regulatory-ready insights. Learn how these innovations are unlocking more efficient, scalable, and fit-for-purpose approaches to evidence generation.
Featured Topics:
- Designing fit-for-purpose RWE studies for regulatory and clinical impact
- Data collection models that reduce burden on sites and patients
- Using AI and unstructured data to derive new endpoints
- Real-world case examples of successful observational programs
Speakers:
- Nancy Dreyer, MPH, PhD, FISPE
Chief, Scientific Advisory Board, OM1
- Eric Schrock
Chief Technology Officer and Head of Evidence Generation Solutions, OM1
Who Should Attend?
- Clinical development and clinical operations
- Regulatory affairs and regulatory strategy
- Real-world evidence (RWE) and health economics & outcomes research (HEOR)
- Rare disease program leadership
- Medical affairs and post-marketing strategy
- Payers