Webinar
From two trials to one
Maximizing the opportunity with real-world data
The FDA’s acceptance of single pivotal trial pathways is reshaping how therapies reach patients, creating new opportunities to accelerate development while managing cost and risk. To succeed in this new one-trial paradigm, organizations must rethink how trials are designed and how evidence is generated.
Real-world data is emerging as a critical enabler, informing smarter trial design, supporting external comparators, and extending evidence beyond traditional trial endpoints. In this webinar, we will explore how these approaches can be applied across the clinical lifecycle, including feasibility, enrollment, and post-market follow-up, along with key regulatory use cases. Join us to learn how leading organizations are modernizing clinical development to move faster, make more confident decisions, and deliver therapies to improve patient lives sooner.
Learn how real-world data helps accelerate patient access to life-saving treatments in a one-trial paradigm by:
- Improving trial design using real-world data for eligibility criteria and event rates.
- Identifying patients and sites with real-time data to support enrollment and execution.
- Applying external comparators and real-world studies to support single trial designs.
- Generating longitudinal evidence for safety effectiveness and label expansion.
- Supporting regulatory submissions with audit-ready real-world data and documentation.
- Extending evidence beyond the trial through continuous post-market follow-up.
