Unified Intake
Social media, EMR systems, clinical trial databases, literature, and patient reports every adverse event source consolidated into a single structured pipeline.
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The Evolution of Safety Intelligence
Empower your Biotech and Pharma safety teams to handle global adverse event volume with clinical precision. Scale excellence across every signal, every language, every regulatory timeline without adding headcount.
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Languages processed
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Avg. AE cases / year at scale
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The Five Pillars of Autonomous PV
A fully automated pipeline that carries every case from multilingual intake to a regulatory-ready narrative, with your experts making the final call.
Social media, EMR systems, clinical trial databases, literature, and patient reports every adverse event source consolidated into a single structured pipeline.
Instantly process safety signals in over 100 languages with medical-grade translation, preserving clinical context, terminology, and regulatory nuance.
Automated MedDRA coding, causality assessment, and expectedness determination with deterministic AI that maps every data point to its regulatory classification.
Auto-generate structured, regulatory-ready patient narratives that maintain consistency across thousands of cases, from raw signal to clinical story.
Every output surfaces for clinical review before submission. Your safety scientists make the final call, supported by AI-prepared context and recommendations.
Live Execution
Real-time intake execution: Automated extraction, translation, and drafting in action.
The Killer Feature
The AI synthesizes clinical data into structured, regulatory ready narratives maintaining consistency across thousands of cases while reducing the burden on PV scientists. Every narrative is built for inspection readiness from day one.
Patient Information: A 62-year-old male with a medical history of type 2 diabetes mellitus, hypertension, and a prior cardiac event (2019).
Event Description: Approximately 3 days following administration of the second dose, the patient experienced nausea and vomiting. Onset date is estimated as 10–11 February.
Concomitant Medications: Metformin 500 mg (diabetes), Lisinopril (hypertension).
Reporter Assessment: Case reported by Dr. Müller via telephone. Additional follow-up required to determine seriousness criteria and dechallenge outcome.
MedDRA Coding: Nausea (PT: 10028813), Vomiting (PT: 10047700).
Regulatory Classification: Pending seriousness assessment. Flagged for expedited follow-up.
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Narrative consistency across cases
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Inspection-ready documentation
The Complexity Gap
You already live this: the queue never empties, and headcount can't keep pace. The only open question is how fast you close the gap.
30–50%
Annual growth in adverse-event reports across pharma sponsors.
~94%
Of adverse drug reactions are never reported. Today's systems only see the tip of the iceberg.
Hazell & Shakir, Drug Safety. Median under-reporting rate across 37 studies.
5–10%
Manual processing error rate on regulated AE intake.
100K+
U.S. deaths each year associated with adverse drug events.
No Rip-and-Replace
Vigintake is the intelligence layer between your intake sources and your safety database: platform agnostic on the way in, regulatory-structured on the way out.
Any source
Social · EMR · Literature · Trials
vigintake
Intake intelligence layer
Your safety database
Whichever one you run
Every processed case exports as a fully structured, gateway-ready E2B(R3) file. Nothing to re-key, no format gymnastics.
Vigintake sits upstream of whichever safety database or case management system you run today. No migration. No rip-and-replace.
AI prepares; your safety scientists approve. Every output surfaces for clinical review before it moves downstream.
Every extraction, translation, and draft is traceable end to end, with documentation built for audit day from day one.
Built for your team
Scale without limits
Handle 10x the case volume with zero compromise on quality. Deliver faster, more accurate results that make your clients wonder how you do it.
Outperform the competition
Stop drowning in journals. Our AI finds what manual screening misses, giving you complete coverage and happier pharma clients.
Take back control
Bring PV in-house. Cut contractor dependency, eliminate compliance gaps, and own your safety intelligence from end to end.
Let's Talk
Let's look at your current intake and drafting bottlenecks and see how we can orchestrate a more efficient future together. Start with a complimentary Workflow Audit.