NeutrinoTech Systems
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Pharma·May 2025

Pharmacovigilance

AE capture, signal detection, and case management automation for global pharmacovigilance operations.

Global
PV operations
FDA / EMA
Aligned
Pharmacovigilance
Challenge

The problem

A global pharmacovigilance operation needed to capture adverse events from multiple sources, detect signals, and manage cases — with audit-grade evidence and regulatory readiness.

Approach

How we engineered it

  • 1Built AE capture across email, voice, and digital channels with document AI for unstructured input
  • 2Implemented signal-detection workflows aligned to FDA and EMA expectations
  • 3Engineered the case-management workflow with reviewer queues and SLA monitoring
  • 4Provided audit-ready evidence for every case state transition
Outcomes

What shipped

Measured outcomes from the program — not promises.

Global
PV operations
FDA / EMA
Aligned
Technology

What we built it on

Nimbledox.AIWorkflow orchestration
Full case study

The complete case study, including detailed timelines and additional context, is published on the Neutrino site.

Read on neutrinotechsystems.com →
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