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.
Discover how Datafoundry’s modular AI platform cuts manual effort by up to 70% while maintaining rigorous global regulatory compliance.
Key challenges we solve:
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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.
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.