AI-Native Drug Safety Operations

Your safety team does the science.
We handle the rest.

Cyntropic automates ICSR case processing end-to-end, intake through submission-ready documentation, with 96–98% first-pass validity and human-reviewed, audit-ready outputs.

Request a Pilot See how it works
91–96%
Extraction accuracy
3×
Faster than manual processing
100%
Audit Traceability
ICSR Processing - Live View ● Active
✓
Case Intake & Triage
Structured + unstructured sources
Done
AI
MedDRA Coding & Narrative
Auto-coded + narrative drafted
In Progress
QC
Human Review & Sign-off
Expert validation layer
Queued
→
E2B Submission Ready
FDA / EMA compliant output
Pending
3 mins
Avg cycle time
100%
Audit Traceability
GxP Validated
21 CFR Part 11 · ICH E2B(R3) · Audit-ready
21 CFR Part 11
GAMP 5
SOC 2
HIPAA
ISO 27001
GxP Validated
What We Do

End-to-End Case Processing

From intake to submission, our AI eliminates manual bottlenecks. Seamless API integration, low latency, and reliable outputs. Purpose-built for CROs and biopharma safety teams.

Intake
SAE Forms
Medical Notes
Emails
Cyntropic AI
Extraction
Coding
Triage
Narratives
Translation
Human Review
Integration
Safety DBArgus, Veeva
XMLE2B R3
CustomAPI
1
Intake

Source documents arrive via API, email, or upload in any format.

  • API-first integration
  • PDFs, emails, voice, scans
  • Sub-second latency
2
AI Processing

AI extracts, codes, triages, and generates narratives automatically.

  • Automated triage and coding
  • AI-generated narratives
  • Multi-language support
3
Review and Submit

Your team reviews finished cases. No manual data entry.

  • Confidence scores per field
  • Source citations built in
  • Export to any safety DB
Who We Serve

Built for life sciences
companies at every stage.

From first-in-human to post-market surveillance, Cyntropic scales with your safety obligations, not against them.

🧬
Emerging Biotech

Your pipeline is growing. Your PV team isn't. Cyntropic gives you enterprise-grade safety operations without hiring a department or signing a long-term CRO contract. Start processing cases within weeks of your first IND.

Phase 1-3 First NDA/BLA Lean teams Flexible scale
🏢
Mid-Size Pharma

High case volume, cost pressure from finance, and a safety team already stretched thin. Cyntropic handles your routine case load so your team focuses on signal detection, aggregate reporting, and regulatory strategy.

High volume Cost efficiency Surge capacity Quality control
🔬
CROs & PV Service Providers

Add AI-powered processing throughput to your existing PV operations. Cyntropic white-labels as your efficiency layer. Your clients get better outcomes, your team delivers more with the same headcount.

White-label Throughput Margin improvement Client retention
The Problem

PV operations weren’t
built for this complexity and volume.

Global adverse event reporting has grown 4× in a decade. Case complexity is rising with combination therapies, rare disease programs, and post-market requirements. The workforce hasn’t kept pace - and neither has the software.

“The question is no longer whether AI can process safety cases accurately. The question is which company is building it with the compliance layer that makes it actually usable.”

01 Noise and scale. Most high-volume post-marketing teams have AEs of low clinical value but require the same processing overhead.
02 Unstructured sources break legacy tools. Hospital forms, literature reports and narrative PDFs require manual processing that creates bottlenecks and quality risk.
03 Emerging biotechs face an impossible choice. Stand up a full PV team you can’t afford or sign a contract you can’t exit - before your first serious AE volume.
04 AI alone isn’t the answer. Most AI tools in PV generate outputs you can’t submit - no validation package, no audit trail, no human sign-off layer.
05 Quality vs. cost tradeoff. Higher quality requires higher cost. Service contracts are inflexible - 3–5 year lock-ins, $80–150 per case, and staffing that doesn’t scale.
How It Works

Submission-ready.
From day one.

Cyntropic combines AI-native automation with a validated human review layer. Every output is GxP-compliant, audit-ready, and submission-formatted - without requiring you to replace your existing safety database.

Start with a pilot →
1
Intelligent Case Intake

Cyntropic ingests ICSRs from every source type - structured E2B XML, unstructured narrative documents, handwritten forms, literature reports, and social media mentions - and normalizes them into a single processing pipeline.

Structured · Unstructured · Handwritten · Literature
2
AI-Driven Processing

Our models perform triage, MedDRA coding, causality assessment, and narrative generation - achieving 91–96% extraction accuracy across all source types. Complex cases are flagged automatically for specialist review.

MedDRA · WHO-DD · ICH E2B(R3)
3
Human Review Layer

Every case passes through qualified PV specialists before submission. This is not optional - it’s the design. Your compliance team gets human-signed documentation with a complete AI + human audit trail.

Expert QC · Audit Trail · Accountability
4
Validated, Submission-Ready Output

Cases emerge formatted for FDA, EMA, and ICH-compliant submission. Pre-built validation packages (IQ/OQ/PQ) satisfy your compliance team on day one - no internal revalidation project required.

21 CFR Part 11 · IQ/OQ/PQ · GxP
5
Integrates With What You Have

Cyntropic connects to your existing safety database - Argus, Vault Safety, ARISg - as an intelligent processing layer. No replacement project. No 12-month implementation. Go live in weeks.

API-first · EHR · Argus · Vault Safety
Why It Works

Compliance is
the feature.

Most AI tools treat regulatory validation as an obstacle. We treat it as a competitive advantage. Every output Cyntropic produces is designed to survive an FDA inspection.

  • Silo model architecture - your data stays intact with the highest level of security and isolation
  • Complete AI + human audit trail on every case, timestamped and exportable
  • CSV validation built in - reduces your compliance team’s validation burden from day one
  • 21 CFR Part 11, ICH E2B(R3), MedDRA, and WHO-DD compliant from day one
  • Human expert sign-off on every submission-bound document - never AI-only output
91–96%
Extraction accuracy
across all source types
60–90%
Extraction accuracy
Industry avg
3×
Faster cycle time
vs. manual processing
<4wk
Time to go-live
vs. 6–12 month CRO
"Cyntropic is a game-changer. Accelerating the PV space with AI is a no-brainer, but Cyntropic is doing a phenomenal job bringing truly compliant AI to market. They've achieved the difficult balance of driving significant cost reduction while maintaining, and even enhancing, the accuracy required in our field. It's the structural efficiency we've been waiting for."
Testimonial
Head of Pharmacovigilance & Patient Safety / Top 10 Pharma
Performance

AI Benchmarks for Pharmacovigilance

Industry leaders are publishing how AI performs in PV. Here's where our system stands against published benchmarks.

95%+
Field-Level Accuracy

Across structured ICSR fields on real-world source documents

80%
Time Reduction

Case processing from hours to minutes per case

<2min
Average Processing

End-to-end from source document to completed case

100%
Audit Traceability

Every AI decision linked to source with confidence scores

ROI Calculator

See Your Savings

Enter your current numbers. See what Cyntropic delivers.

$0
Estimated Annual Savings
0
Hours Saved / Year
0
More Cases / Year (Same Team)

Based on 40% cost reduction and 95% field-level accuracy. Actual results may vary.

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Our Team

Pharma Expertise Meets Silicon Valley AI Innovation

Based in the San Francisco Bay Area, we are a team of pharmacovigilance veterans and AI professionals with over 30 years of combined experience dedicated to making drug safety faster and more accurate.

FAQ

Any Questions? Look Here

Common questions about our AI-powered pharmacovigilance solutions.

Our proprietary AI is built specifically for the life sciences industry, incorporating GxP principles and rigorous data privacy standards to ensure every automated step is audit-ready.

Yes, our advanced AI models are trained to extract structured fields from a wide variety of unstructured sources, including handwritten forms and low-resolution scans.

Absolutely. Cyntropic AI is designed to sit alongside your current infrastructure, automating the "heavy lifting" of data entry and narration before pushing validated data into your primary safety system.

Unlike generic LLMs, our AI models are trained on domain-specific pharma datasets and medical taxonomies, ensuring higher accuracy in AE extraction and medical coding.

We view AI as an accelerator, not a replacement. Our system provides a streamlined interface for PV staff to review, edit, and approve AI-generated outputs, maintaining full human oversight.

We work closely with your team to understand your unique SOPs. Most partners have our AI systems up and running with a customized implementation in weeks, not months.
Contact Us

Get in Touch

See how leading pharma and CRO teams are cutting costs and meeting deadlines with AI-powered case processing.

Email

hello@cyntropic.com

Location

San Francisco, USA

Schedule a Call

Book a demo