A modern, GxP-aligned,
AI-assistedAI-assisted pharmacovigilance
platform
Enterprise-grade capability for the end-to-end ICSR workflow — on modern, cloud-native technology, fully hosted with zero client-side IT setup, and AI-assisted with people in control of every regulated decision.
Data Sources
Automatic Ingestion
AI Processing
Intelligent Analysis
Validation
Smart Classification
Data Output
Structured Export
Aligned with the world's regulatory authorities
PVgenix is built around the standards, formats, and reporting obligations of the major pharmacovigilance regulators worldwide.
ICH
Standardizing global pharmacovigilance processes.
EMA
Ensuring EU compliance for drug safety & risk management.
FDA
Meeting stringent U.S. PV & regulatory guidelines.
MHRA
Compliant with UK drug safety regulations.
CDSCO
Supporting Indian regulatory requirements for ADR monitoring.
Everything the core ICSR workflow needs
Six capability areas, one connected case record — from multi-channel intake through regulatory submission, with qualified people approving every regulated step.
Multi-channel intake with automated extraction and case creation — reviewed and approved by qualified people before a case proceeds.
Disproportionality methods (PRR, ROR, BCPNN/IC, EBGM), masking detection, and configurable thresholds across the signal lifecycle.
Scheduled searches with automated screening and AI-assisted ICSR identification — confirmed by a qualified reviewer.
Regulatory clock and rules engine, E2B(R2)/E2B(R3) generation, and a built-in AS2 gateway with submission-compliance tracking.
DSUR and PBRER/PSUR support, line listings, and summary tabulations — with data reuse across reporting outputs.
Integrated QMS with CAPA, deviation, and change-control tracking — tied to case processing and inspection support.
Equivalent core capability, modern delivery
Many existing safety systems run on older technology and cost models. PVgenix delivers the same regulated capability on current-generation, cloud-native technology — without the long cycles or heavy licensing.
Multi-month professional-services engagement
Guided onboarding in weeks, not quarters
Heavy per-seat licensing, locked into long terms
Transparent subscription that scales with you
On-prem servers maintained by your own IT team
Fully managed, cloud-native hosting by Bright Infonet
Scheduled, disruptive upgrade windows
Continuous delivery with zero downtime
Evidence gathered manually for every audit
GxP-aligned and audit-ready by design
Two deployment models,
one codebase.
Run PVgenix as a fully hosted multi-tenant SaaS or as a dedicated single-tenant deployment — both built from a single product codebase for complete feature consistency.
models
codebase
for SaaS
Multi-tenant SaaS
Fully hosted and managed by Bright Infonet with logically isolated tenants, provisioned from the portal with no client-side IT setup.
Dedicated single-tenant
Isolated application and database per client, deployable in the client's preferred environment with full control over the hosting stack.
Surface real signals, not noise
Run quantitative disproportionality across the safety database, apply masking detection, and tune thresholds for each stage of the signal lifecycle — every flagged signal routed to a qualified assessor.
PRR, ROR, BCPNN/IC and EBGM computed continuously, with confidence intervals and case-count gating.
Identify where a high-frequency event hides emerging signals, and re-stratify automatically.
Set method-specific cut-offs per product, per lifecycle stage, with a full audit trail of every change.
One pipeline, every case in view
Track each ICSR from intake through submission in a single live console — every stage time-stamped, AI-assisted, and gated by qualified review, with operational metrics updating in real time.
See PVgenix on your own cases
Book a walkthrough of multi-channel intake, AI-assisted extraction, and the compliance documentation package.