For Pharma & Device

The evidence you need already exists. The problem is getting to it.

Every day, hospitals generate outcomes data, safety signals, and real-world performance records that could support your submissions. That evidence sits behind firewalls. Not because it does not exist, but because the infrastructure to reach it safely did not exist. Until now.

Note: The December 2025 guidance applies to medical devices. On December 15, 2025, FDA also issued a press release stating it will accept RWE without requiring identifiable patient data for drugs and biologics as well.

Regulatory-grade evidence. A fraction of the timeline.

Traditional data licensing takes six months to two years or more and still leaves exposure around data provenance and patient consent. NexusRWE generates the same quality of evidence with a cleaner legal footprint and a built-in audit trail formatted for submission.

Where NexusRWE creates value for sponsors:

Post-market safety surveillance - Continuous monitoring across a live hospital network, without waiting for periodic data pulls or registry updates.
External control arms - Generate a comparison population from real-world data to support device submissions where a randomized trial is impractical.
Natural history studies - Characterize disease progression across distributed patient populations without moving a single record.
Label expansion - Generate evidence to support new indications using real-world data without centralizing patient records.
AI/ML model validation - Validate algorithms across geographically distributed patient populations without centralizing any data.
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See it in action

Use Case 1 · Built for ICH M14

A Post-Market Safety Study

What this looks like in practice

A pharma sponsor has a cardiovascular drug on the market. Spontaneous reports suggest elevated stroke risk in patients over 75. Under ICH M14, they need a structured pharmacoepidemiological study across multiple health systems - fast, defensible, and submission-ready.

The old way

Negotiate data use agreements with five hospital systems. Sign HIPAA agreements. Wait for IRB approvals. Export patient records to a central server. Run the analysis. Reformat everything manually for submission. That's six months to two years or more and seven figures spent - with patient data sitting outside the hospitals where it was generated.

With NexusRWE

The sponsor submits a locked study protocol. Each hospital approves it through their own governance process. The analysis runs locally inside each hospital - patient data never moves. When the privacy budget is spent, the system stops automatically. Encrypted results are returned - each one traceable to its source. The platform generates a submission-ready evidence package automatically.

The outcome

Months, not years. No data ever leaves the hospital. Every step is auditable and traceable.