Cloud-native, AI/ML-powered pharmacovigilance for end‑to‑end case management. Automates intake, coding, triage, narrative writing, QC, and regulatory submissions—reducing manual workload and tightening global PV compliance.
Transform Safety Vigilance with AI-Powered Automation
Discover how Datafoundry’s modular AI platform cuts manual effort by up to 70% while maintaining rigorous global regulatory compliance.
Datafoundry uses MediLP (medical NLP) and GxP-compliant AI to turn messy safety data into intelligence. We help pharma and biotech teams automate workflows, cut costs and improve health outcomes.
Key challenges we solve:
Regulatory Risks triggered by scattered data in legacy systems.
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$10BNPV penalties/year
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$7BNfaulty labels penalties
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$2Mper product per region
Ineffective Signal Detection & Management
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$43Mcost per major safety compliance failure
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$11.2Bpaid annually in global pharma non-compliance fines
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$20Mto remediate a single regulatory warning or consent decree
Inability to accurately predict future outcomes that can be trusted.
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$250Mper product recall
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$450BNin frauds
The Intelligence Behind Your Safety Team
AI-enabled signal management that ingests multi-source safety data, runs real-time disproportionality and trend analytics, and applies FMEA-based risk scoring. Supports active and passive surveillance, configurable clinical risk flags, and full lifecycle signal reporting.
Intelligent global literature surveillance for PV and medical teams. Automates retrieval from major databases, de-duplicates, applies NER/RE to detect drugs and events, ranks relevance, translates non-English articles, and exports cases in CIOMS and E2B (R2/R3) formats.
End-to-end cosmetovigilance and post-market safety for global cosmetic brands. Uses AI to capture and structure adverse events from consumer channels, automate seriousness and causality assessment, generate narratives, and maintain compliance with MoCRA, EU Cosmetics Regulation, NMPA, and other regional frameworks.