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Case Study (Non- CE) Hosted By Curavit: Build Regulatory-Grade by Deploying Prospective Linkage and Virtual Sites to Satisfy FDA Standards
Session Chair(s)
Dave Hanaman
President & Co-Founder, Curavit, United States
Retrospective real-world evidence often fails regulatory scrutiny due to data gaps, selection bias, and unresolvable data provenance. To overcome these structural limitations, life sciences organizations must shift to prospective, execution-driven evidence generation. This session presents an integrated blueprint combining virtual clinical sites, instant eligibility screening, and patient-authorized record linkage to capture audit-ready data continuously across multi-year horizons. Attendees will explore real-world case examples demonstrating how to generate defensible, regulatory-grade RWE that satisfies FDA mandates while accelerating trial timelines.
Learning Objective : At the conclusion of this session attendees should be able to:- Identify and overcome core flaws in traditional retrospective RWE, including missing data and selection bias
- Apply a framework combining decentralized execution, tokenized record linkage, and analytics to meet FDA standards
- Evaluate real-world implementations of automated screening and patient linkage to power External Control Arms
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