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One Global AI-native suite. Five validated platforms.

Pharmacovigilance, clinical data capture, quality, medical info, and trial budgeting — built to interoperate, validated to ship.

One Global AI-native suite. Five validated platforms.

Pharmacovigilance, clinical data capture, quality, medical info, and trial budgeting — built to interoperate, validated to ship.

PV.app

All-in-one safety platform

Medical liaisons, doctors, pharmacists, patients & caregivers send safety reports directly to pharma and regulators — coded, deduped, and submitted by AI.

  • AI-driven case intake from MedWatch, Literature, Spontaneous sources
  • Automated MedDRA coding with 60% faster case processing
  • Automated expectedness assessment for consistent evaluation
21 CFR Part 11GAMP 5GVPEU Annex 11

eQMS

Stay compliant

AI-powered quality management: document control, CAPA, eLMS, risk matrix, and external signing — deployed in days, not quarters.

  • AI-powered document drafting for rapid QMS deployment
  • Smart approval routing with Outlook calendar integration
  • Automated CAPA with evidence attachment and workflows
21 CFR Part 11GAMP 5ISO 9001ISO 27001

EDC + ePRO

Convenient eCRF Collection

Cost-effective EDC + ePRO for decentralized and hybrid trials. Collect data directly from patients, validated in real time, with budget control wired in.

  • ePRO-to-EDC integration eliminates data duplication
  • Real-time data validation prevents errors and ensures compliance
  • Intuitive ePRO forms with patient direct data entry
21 CFR Part 11GAMP 5GCPEU Annex 11

MICC

Medical Information Call Center

Omnichannel medical information with AI copilot, speech-to-text, automatic adverse event capture, and direct PV handoff.

  • AI copilot handles routine inquiries, 35% workload reduction
  • Multi-channel support: phone, email, web forms, and live chat
  • Automatic speech-to-text conversion for conversation capture
21 CFR Part 11GAMP 5ISO 9001GDPR

AI Governance Hub

Explainable AI for medical coding & adverse event classification

The control plane for every AI decision in your safety and clinical workflow — explainable, validated, audit-ready.

  • Per-decision explainability and model lineage
  • Human-in-the-loop override and revalidation
  • Drift monitoring and retraining triggers
21 CFR Part 11GAMP 5GVP

Regulatory-grade by design.

21 CFR Part 11
GAMP 5
GVP
GCP
ISO 9001
ISO 27001

Ready to consolidate your eClinical stack?

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