The biggest bottleneck in real-world evidence isn't the data. It's trust.

Hospitals sit on some of the most valuable clinical data in the world. Pharma and device companies desperately need it. But the legal, regulatory, and reputational risk of sharing patient records has made that exchange nearly impossible. Until now.

NexusRWE has built a patent-pending federated architecture that solves this at the infrastructure level. Instead of moving data to sponsors, we send queries to the data. Computations run locally inside hospital systems, results are encrypted and validated before release, and sponsors receive regulatory-grade evidence packages ready for FDA submission. All while hospitals retain full custody of their patient records. No data leaves. No risk is created. No compliance corners are cut.

The regulatory window is open. In December 2025, the FDA issued final guidance establishing a formal pathway for real-world evidence in device regulatory decisions, covering 510(k) clearances, post-market surveillance, and AI/ML model validation. NexusRWE is uniquely positioned to deliver on this moment.

We work with medical device and pharmaceutical companies that need compliant, scalable real-world evidence for post-market surveillance, comparative effectiveness, external control arms, label expansion, and safety signal detection. And we partner with health systems ready to unlock the value of their data assets without the legal or reputational exposure that comes with sharing them.

Founded by a team with 15+ years in FDA-regulated life sciences and 20+ in health data infrastructure, including federated networks spanning 100+ hospitals, 50+ published studies, and enterprise engineering leadership through a successful Oracle acquisition.

The data already exists. We make it usable.

NexusRWE

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