AI-Native Drug Safety Platform

An AI-First, Unified Platform
Advancing Safer Medicines

One end-to-end platform with connected intelligence across the entire drug-safety lifecycle. Built AI-native from the ground up, not a layer bolted onto legacy systems.

"AI That Thinks With You, Not Just For You."

Discovery → Clinical → Post-Marketing Surveillance → Real-World Evidence
Our vision

Reimagining drug development with connected intelligence.

The pharmaceutical industry stands at a pivotal crossroads, pressed to break free from prolonged discovery cycles and fragmented, disconnected data. At TheragenX, we envision a transformative future where AI doesn't just automate tasks; it accelerates science itself.

"AI That Thinks With You, Not Just For You."

One connected data thread
Discovery
Early signals captured at the source
Clinical
Trial data linked to safety in real time
Post-Marketing Surveillance
Continuous monitoring across sources
Real-World Evidence
Insight that feeds back into the platform
Full data lineage, discovery to real-world evidence.
One Platform · Eight Modules

Everything you need across the drug-safety lifecycle

Eight AI-native modules on one connected data layer. Adopt what you need today; add the rest as you scale.

Why TheragenX

We're Building What's Next

Six ways TheragenX breaks from legacy, monolithic safety systems, built AI-native from the ground up.

How it works

Live in weeks, not months

A modular rollout that scales from local to global operations with no heavy IT lift.

1

Connect

Integrate your data sources, gateways and existing systems in days.

2

Configure

Set triage rules, workflows and role-based access to your SOPs.

3

Validate

Automated validation gives you an inspection-ready evidence trail.

4

Go Live

Run global operations with real-time intelligence from day one.

Compliance, built in

Inspection-ready at every layer

Compliance is embedded from the ground up, with automated audit trails and alignment to global standards, not bolted on at the end.

FDAEMAICHMHRA21 CFR Part 11GxP
  • Automated, tamper-evident audit trails on every action
  • Real-time consistency checks and error detection
  • Updatable triage rules that adapt to regulatory change
  • Standardized global workflows on medical standards (MedDRA)
  • Continuous, automated computer-system validation
Trust Center

Certified, compliant, and built on trusted AI

Security, data protection and regulatory compliance are engineered into the platform, validated against the standards that govern modern drug safety, not bolted on after the fact.

Recognized for AI innovation

TheragenX Joins the NVIDIA Inception Program

TheragenX accepted into NVIDIA Inception to advance AI-driven safety

Through NVIDIA's accelerated computing and AI expertise, we will further strengthen our ability to train, optimize, and deploy high-performance models across case intake, literature monitoring, signal detection, aggregate report authoring, and regulatory analytics.

NVIDIA
Inception
Program

Ready to advance safer medicines?

See how TheragenX unifies your drug-safety operations on one AI-native platform.