Production · 66 Sprints · 350+ Endpoints

The AI-Native
Pharmacovigilance
Platform

SafetySignal AI automates adverse event detection, causality assessment, regulatory reporting, and benefit-risk evaluation — powered by a 7.6B parameter PV model trained on real-world safety data.

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3K+

Cases Processed

94%

CIOMS XIV Compliant

Causality Assessment

Live Signal Queue

● 3 Active Alerts

🚨

Amoxicillin → Anaphylaxis

10 cases · 15-day expedited required

CRITICAL 92

⚠️

XARELTO → Death

7 cases · HIGH priority

HIGH 68

📊

JAKAFI → Thrombocytopenia

PRR 16.1 · 3 methods detecting

MED 46

✅

E2B(R3) XML Generated

FDA FAERS · 3,585 chars · 0.02s

READY

✓ ICH E2B(R3)

✓ GVP Module VI/IX

✓ 21 CFR Part 11

✓ CIOMS XIV

✓ FDA FAERS

✓ EMA EudraVigilance

Platform Capabilities

Every PV Workflow,
Powered by AI

From case intake to regulatory submission — SafetySignal AI replaces manual workflows with AI-native automation in seconds, not days.

🧠

AI Causality Assessment

Three-algorithm consensus using Naranjo, WHO-UMC, and Kramer — powered by SafetySignal-PV-7B v3, a 7.6B parameter model fine-tuned on real adverse event data. 80% agreement with Claude Sonnet 4.

SafetySignal-PV-7B v3

📊

Signal Prioritization Scoring

Composite priority score combining PRR/ROR/IC/EBGM, causality strength, clinical severity, case volume, and novelty. A ranked queue that Oracle Empirica cannot produce alone.

BRAT Framework · Sprint 60

⚖️

Benefit-Risk Assessment

World's first AI-native BRAT benefit-risk evaluation engine. ICH E2C(R2)-aligned assessments from case data in under 50ms — a capability no legacy PV platform offers.

First-in-Class · Sprint 66

🏷️

Labeling Gap Detection

Automated listedness determination — cross-references signals against product labeling to flag unlisted AEs requiring 15-day expedited reporting per ICH E2B(R3).

ICH E2B(R3) · Sprint 62

📋

E2B(R3) XML Generator

Submission-ready ICH E2B(R3) ICSRs with all required fields generated in milliseconds. Patient demographics, drug details, causality assessment, narrative — FDA and EMA formats.

FDA · EMA · Sprint 65

📚

Literature Surveillance

Automated PubMed portfolio surveillance — extracts AE signals from abstracts, cross-references against case DB, and flags literature-only signals not yet in FAERS data.

PubMed API · Sprint 61

📈

Signal Trending Over Time

Week-over-week signal emergence tracking across 344+ drug-AE pairs. Identifies NEW, RISING, DECLINING, and STABLE signals with WoW% changes for regulatory intelligence.

Portfolio Level · Sprint 63

📄

ICH Narrative Generation

ICH E2B-compliant individual case narratives auto-generated from structured data with completeness scoring and quality grading A–D. Eliminates manual PV authoring.

ICH E2B · Sprint 59

🏥

Regulatory Intelligence Dashboard

Consolidated compliance status, KPI tracking, deadline alerts, signal queue, and risk heatmap — aggregated from 130+ CIOMS XIV tables. Platform health score included.

CIOMS XIV · Sprint 64

Integrations

Native Oracle
Argus Integration

SafetySignal AI connects directly to Oracle's PV ecosystem — augmenting Argus Safety, Empirica Signal, and Argus Mart without replacing your existing infrastructure.

🔗

Argus Safety Bidirectional Sync

Real-time case data exchange with Oracle Argus Safety via REST API and E2B messaging. SafetySignal enriches Argus cases with AI-generated causality assessments and narratives.

📡

Empirica Topics SOAP API

Connect to Oracle Empirica Topics Web Service to import signal detection results and augment with SafetySignal's composite priority scoring and benefit-risk assessment.

🗄️

Argus Mart Data Connector

Direct read access to Argus Mart analytical data warehouse. Pull aggregate safety data and case listings into SafetySignal's regulatory intelligence dashboard.

☁️

OCI Kubernetes Deployment

Deploy SafetySignal AI alongside Oracle Cloud Infrastructure using validated Terraform and Kubernetes manifests for GxP-compliant enterprise deployments.

Ora

Oracle PV Ecosystem

SafetySignal AI Integration Matrix

Oracle Argus Safety (Cloud)