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.
The Five Pillars of Autonomous PV
A fully automated pipeline that handles every stage of pharmacovigilance from multilingual intake through regulatory ready narratives.
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.
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.
99%+
Narrative consistency across cases
60%+
Reduction in drafting time
Always
Inspection-ready documentation
The Complexity Gap
The sheer volume of global safety data, especially from digital and social channels, has outpaced traditional manual workflows. The question is no longer whether to adopt intelligent automation, but how quickly you can bridge the gap to sustainable compliance.
30–50%
Annual AE Growth
Adverse Event reports are growing 30–50% annually from diverse sources, overwhelming manual processes and causing backlogs.
5–10%
Manual Error Rate
Manual processing is slow, costly, and error-prone. Mid-to-large pharma companies averaging 700,000 AE cases per year face mounting operational costs and compliance risks.
Limited
Skilled Personnel
Extracting quality patient AE data from noisy, unstructured social media is challenging. Limited skilled personnel are strained, hindering timely signal detection.
Built for your team
Handle 10x the case volume with zero compromise on quality. Deliver faster, more accurate results that make your clients wonder how you do it.
Stop drowning in journals. Our AI finds what manual screening misses, giving you complete coverage and happier pharma clients.
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.