Turn unstructured EMR data into regulatory-grade evidence — faster, cheaper, and fully traceable.
Why download this whitepaper:
- ⚖️ Stay compliant — Understand how the FDA’s 2024 guidance and EMA’s DARWIN EU expansion are redefining standards for RWE quality, provenance, and validation.
- ⚙️ See what’s broken — Learn why manual abstraction and point solutions fail under today’s regulatory expectations, costing up to 25% of trial budgets.
- 🤖 Discover the solution — Explore automated evidence generation using AI, NLP, and Human-in-the-Loop review to deliver validated, CDISC-compliant data directly from patient-consented sources.
- 🔍 Go beyond benchmarks — See how to avoid the “AI Benchmark Fallacy” with visual audit trails and expert review workflows that regulators can trust.
- 📈 Proven results — Real-world examples show 5x faster extraction and 80% cost reduction across oncology, GLP-1, and rare disease studies.
Download now to see how automated evidence generation can help you meet evolving FDA and EMA standards—while accelerating study timelines and reducing cost.