# NovigaAI - AI-Native Pharmacovigilance & Safety Intelligence Platform

## Overview
NovigaAI is an AI-native pharmacovigilance and safety intelligence platform that connects adverse-event reports, scientific literature, real-world data, and social channels into a unified platform for case processing, signal detection, and regulatory reporting.

## Core Capabilities

### Signal Detection
- Statistical signal detection using PRR, ROR, Information Component (IC), and EBGM
- Sequential testing with alpha-spending boundaries to prevent false positives
- Multi-dimensional scoring combining statistical strength, clinical seriousness, novelty, and cross-source concordance
- Cross-source concordance analysis across FAERS, JADER, literature, and social media

### Signal Investigation
- Expert-led signal assessment with Bradford Hill causality framework
- Evidence dossier compilation from statistical, literature, clinical, and mechanistic sources
- Cluster analysis by drug class, mechanism, reaction SOC, and patient population
- Regulatory action tracking from validation through label updates and RMP modifications

### Case Management
- End-to-end ICSR processing with AI-assisted extraction, MedDRA coding, and duplicate detection
- E2B(R2/R3) import/export with full round-trip fidelity
- Deterministic fingerprint and semantic similarity duplicate detection
- CIOMS-style narrative generation with reviewer editing
- 21 CFR Part 11 aligned electronic signatures and audit trails

### Literature Intelligence
- Automated screening of PubMed, OpenAlex, ClinicalTrials.gov, and FDA sources
- Multi-stage AI filtering: fast filter → deep relevance → regulatory potential scoring
- ICSR 4-criteria validation (identifiable patient, suspect product, adverse event, source)
- Day-zero timeline with 15-day expedited reporting deadline tracking
- GVP Module VI aligned literature screening SLA compliance dashboards

### AI Investigation Agents
- Literature Agent: Multi-source scanning with AI relevance scoring and ICSR eligibility checks
- Case Agent: AI-assisted extraction, MedDRA coding, duplicate detection, narrative generation
- Signal Agent: Statistical detection, Bradford Hill assessment, cross-source concordance
- Compliance Agent: Deadline tracking, report versioning, audit trail generation, regulatory validation
- Safety Intelligence Agent: Executive briefings, portfolio heatmaps, usage and efficiency analytics

### Evidence Graph
- Knowledge graph connecting drugs, targets, genes, proteins, diseases, and phenotypes
- Provenance tracking for all relationships
- Mechanism-based safety hypothesis generation
- Graph traversal for target safety intelligence

### Safety Analytics
- Executive command center with portfolio overview, signal counts, critical priorities
- AI-generated safety briefings grounded in tenant data with evidence citations
- Drug-reaction heatmaps (PRR trends) and emerging cluster detection
- Usage and efficiency analytics for processing throughput

### Regulatory Reporting
- PSUR/PBRER aggregate report authoring with version control
- CIOMS form generation
- Risk Management Plan (RMP) authoring
- Expedited reporting deadline tracking with automated alerts
- Electronic signatures and audit trails

### Platform Architecture
- Domain-driven design: independent services for Case, Signal, Literature, Ingestion, Reporting, Portfolio, Notification, AI Retrieval
- Polyglot persistence: PostgreSQL (OLTP), ClickHouse (OLAP), Qdrant (Vector), Memgraph (Graph), S3/MinIO (Artifacts)
- NATS event backbone with idempotent consumers for reliable processing
- Container-native, Kubernetes-orchestrated, multi-region deployment ready
- Open REST/GraphQL APIs with E2B(R2/R3) import/export and HL7 FHIR alignment

## Regulatory Alignment
- GVP Module VI (Case Processing)
- GVP Module IX (Signal Management)
- ICH E2A, E2B(R3), E2C(R2)
- 21 CFR Part 11 (Electronic Records/Signatures)
- CIOMS I, VI, VIII
- ISO 27001 aligned controls and a SOC 2 Type II programme

## Target Audiences
- Pharmaceutical & biotechnology safety teams
- Pharmacovigilance service providers (CROs)
- Regulatory affairs and quality functions
- Medical safety reviewers and signal investigators
- Leadership requiring portfolio oversight

## Contact
- Website: https://www.novigaai.com/
- Demo Request: https://www.novigaai.com/contact/#demo
- LinkedIn: https://www.linkedin.com/company/noviga-ai/