AI-driven adverse event detection for pharma companies, MAHs, CROs, and regulatory affairs teams. Scale case volume, accelerate signal detection, and keep your audit trail inspection-ready — while safety scientists focus on the analysis that matters.
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Automated case processing, continuous signal detection, and regulatory submission management — delivered by an AI platform built to the governance standards regulators now expect.
NLP extracts structured case data from patient narratives, physician letters, literature, and social media automatically. Cases triaged by seriousness, expectedness, and reporting timeline — 7-day expedited cases flagged immediately. MedDRA coding suggestions generated for human review.
ML signal detection runs continuously alongside traditional disproportionality analysis — catching subtle correlations before enough cases accumulate for statistical methods to fire. Literature monitoring and social media surveillance surface signals from sources manual review cannot cover at scale.
ICSRs auto-formatted to E2B(R3) standards, validated for completeness, and submitted across EudraVigilance, FDA FAERS, CDSCO, and others simultaneously. Status, acknowledgements, and follow-up requests tracked in a single workflow. Inspection-ready at all times.
Case volumes are growing every year. More products, more reporting channels, more international markets with local requirements. The team that managed last year's volume needs to be significantly larger to manage next year's — unless the process changes fundamentally.
See How We Fix ThisThe full PV operational workflow — case intake, MedDRA coding, safety narratives, signal detection, literature monitoring, and regulatory submission — automated from a single platform for MAHs, CROs, and regulatory affairs teams.
Five purpose-built workspaces for case processors, safety scientists, signal managers, and regulatory submission teams. AI handles the volume; your team handles the judgment.
Incoming cases from all sources in a single prioritised queue — triaged by seriousness, expectedness, and submission deadline. Pre-populated case fields from NLP extraction, MedDRA coding suggestions ready for review, and AI-drafted safety narrative attached. A case processor works through what would have taken four hours in ninety minutes.
Emerging patterns across your safety database displayed with clinical significance scores, novelty ratings, and supporting case evidence. ML-detected signals alongside traditional disproportionality analysis — the subtle correlations that statistical methods miss until a larger case series has accumulated. Every signal a safety scientist needs to evaluate, prioritised so the most important ones are never buried.
Continuous monitoring output across primary journals, pre-print servers, conference abstracts, and regional publications. Social media and patient forum signals from digital sources screened against your existing case data and flagged for assessment when they meet relevance criteria. Coverage that no manual monitoring programme can match at volume.
Every active submission across all regulatory databases — EudraVigilance, FDA FAERS, CDSCO, and others — with status, deadline, acknowledgement, and follow-up tracking in one view. E2B(R3) formatting and completeness validation automated per case. Submission preparation time reduced from hours to minutes. Your submission record complete and inspection-ready at all times.
Full audit trail for every AI output, human review decision, coding change, and submission event. GxP validation documentation for every model in regulatory-facing workflows. Performance monitoring dashboards demonstrating ongoing model fitness. Everything your quality assurance and regulatory affairs teams need for inspections — assembled continuously, not retroactively.
Each metric ties to a real operational outcome from AI-driven case processing, signal detection, or regulatory submission management.
Book a PV Automation DemoBuilt for every organisation with pharmacovigilance obligations — from post-marketing MAHs managing large ICSR volumes to clinical-stage biotechs building their PV infrastructure from scratch.
GVP obligations require systematic case processing, signal detection, and literature monitoring. AI meets them at lower cost and higher quality than manual processes at post-marketing volumes — with the audit trail and validation documentation inspectors expect built into every workflow.
PV service performance is measured on speed, accuracy, and compliance. AI delivers all three while absorbing higher case volumes without proportional headcount growth — a direct differentiator when sponsors are comparing CRO PV performance quantitatively.
Phase I/II safety surveillance carries the same regulatory rigour as post-marketing PV at lower volumes. Cost-effective AI tools make compliant surveillance accessible without a large in-house PV infrastructure — giving early-stage companies the operational standard of a much larger organisation.
CDSCO requirements have grown more rigorous. A cost-effective, compliant PV operation meeting both Indian and international standards — with regional language case intake in Hindi, Tamil, Telugu, Kannada, Marathi, and Bengali — is essential for companies with global ambitions.
Multi-product portfolios mean simultaneous obligations to EudraVigilance, FDA FAERS, CDSCO, and others — each with its own format, deadlines, and follow-up workflow. One platform manages all of it with a complete submission record that is inspection-ready at all times.
Pharmacovigilance Automation integrates with your existing safety database, case management, and regulatory submission infrastructure — validated to GxP standards, with full audit trail and inspection-ready documentation built into every workflow.
Connects to leading PV safety databases within your existing data governance and validation framework — no replacement of core safety infrastructure.
Submits to all major national and regional PV databases simultaneously — with unified tracking of status, acknowledgements, and follow-ups.
All standard medical coding terminologies used in PV case processing and regulatory reporting.
Every regulatory-facing AI model validated with a GxP-compliant documentation package. Built to meet PV compliance requirements across multiple jurisdictions.
All reporting channels — spontaneous, literature, digital, clinical trial — processed through a unified NLP intake layer.
NLP case intake in Indian regional languages — for consumer reports and literature monitoring from regional publications.
Every signal AI finds faster — or surfaces from previously unmonitored sources — is a real opportunity to protect patients and your product's future. Book a 30-minute demo to see how the platform handles your case volumes, submission obligations, and signal detection requirements.
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The platform is developed and validated under GxP principles — documented lifecycle, IQ, OQ, PQ, and ongoing performance monitoring. Every regulatory-facing AI model has a validation package demonstrating fitness for purpose. The joint FDA and EMA 2026 guiding principles on AI governance in PV are reflected throughout the platform's documentation and audit trail architecture.
Every AI output is reviewed by a qualified human before entering the safety database or reaching a regulator. The AI handles speed and consistency; the human handles final QA and complex judgment. Errors caught in review feed back into model improvement. The platform is a collaboration tool, not a replacement for qualified PV professionals.
Yes. NLP models for Hindi, Tamil, Telugu, Kannada, Marathi, Bengali, and other regional languages are available for case intake and literature monitoring — covering consumer reports from local channels and Indian medical publications. Required for CDSCO PvPI compliance as India's consumer reporting infrastructure expands.
Only publicly available information is processed. Posts are not linked to identifiable patient records without consent. The platform extracts aggregate safety signals from digital sources — not individual patient profiles. All monitoring operations are documented in the privacy impact assessment and data processing records.
EudraVigilance, FDA FAERS, CDSCO PvPI, and others are managed within a single interface. Each database's formatting requirements, deadlines, and follow-up workflow are handled automatically. Your regulatory team gets a unified view of all submission obligations and statuses across every market.
PubMed, Embase, conference abstracts, pre-print servers, and regional medical journals in supported languages are monitored continuously. Coverage is configured per product and indication. Relevant new papers are screened against existing case data automatically — those with potentially new safety information flagged within the defined review period.
