Case Processing
Vigintake's AI agents ingest, triage, and classify adverse events in minutes. Reduce cycle times by 80%, minimise rework, and meet regulatory timelines consistently.
The Challenge
Safety teams at service providers and biotechs face growing pressure: higher case volumes, tighter timelines, increased regulatory scrutiny, and constrained resources.
Staff manually reading PDFs, emails, and faxes to extract case data. The process is time-consuming and susceptible to human error at every step.
QC rejections, MedDRA mis-coding, and incomplete narratives require multiple rounds of review before a case reaches submission readiness.
Case volumes are unpredictable, but 15-day SUSAR deadlines are not. Managing this gap introduces compliance risk and operational strain.
How It Works
Cases arrive from any channel: email, fax, e-commerce platforms, portals, and call centres. Vigintake consolidates every source into a single, structured intake queue.
NLP agents parse unstructured text, extract all ICSR fields, apply MedDRA coding, and perform regulatory triage classification in under 2 minutes.
AI drafts the full case narrative and populates the E2B(R3) XML structure, covering patient data and seriousness criteria, ready for medical review.
Structured export to Argus, ARISg, VigiFlow, or E2B XML, with a full audit trail, version control, and regulatory-ready documentation at every stage.
Core Capabilities
Trained on millions of case narratives, our models achieve 99.4% MedDRA PT accuracy, meeting or exceeding typical human reviewer benchmarks.
Adverse events are received in any language. Our models translate, extract, and code while preserving clinical nuance and regulatory context.
Structured, ICH E2B-compliant narratives generated in seconds. Consistent style, complete content, and significantly reduced time to authorisation.
AI-assisted causality classification using WHO-UMC criteria. Borderline cases are flagged for human review; clear-cut cases are routed automatically.
Probabilistic matching across sources ensures follow-up cases are correctly linked to the master case, preventing duplicate submissions.
Every decision, edit, and override is timestamped and immutable. Inspection readiness is embedded in the workflow, not added as an afterthought.
Who It's For
Managing case volumes across multiple clients, each with different databases, SLAs, and reporting requirements, requires exceptional operational discipline. Vigintake's multi-tenant architecture and configurable workflows support higher throughput per FTE.
Establishing a compliant pharmacovigilance operation from the ground up requires both regulatory expertise and scalable infrastructure. Vigintake accelerates GVP-compliance and reduces dependence on manual headcount through intelligent automation.
Integrations
Vigintake integrates with industry-standard safety databases via HL7 FHIR, E2B XML, and REST APIs, without requiring disruptive changes to your existing systems.
Get Started
See how Vigintake processes a real adverse event case from intake to E2B submission in under 3 minutes, using your own data.