Use Case 1: 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.