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Clinical Trial Suite · 4 Modules
The whole safety lifecycle, governed end to end.
Seven integrated modules — from case intake through signal detection, regulatory intelligence and quality management. Governed AI accelerates triage, coding and drafting; qualified reviewers own every regulated decision; every action is audit-trailed.
13
Modules
1
Safety database
12+
Authorities tracked
100%
Audit-trailed
PV-01
Intake
Case intake
PV-02
ICSR
Case processing
PV-03
Crypta
Literature monitoring
PV-02
Signum
Signal detection
PV-05
Reg Intel
Regulatory intelligence
PV-06
RMP
Risk management
PV-07
Materiovigilance
Device adverse-event surveillance
PV-08
Qualitus · QMS
Quality management underpinning every module
One safety database · one design system · one audit trail
128k
ICSRs processed
340k
Articles screened
12
Authorities monitored
99.4%
On-time submissions
The modules
Eight modules. One safety system of record.
Adopt one module or the whole suite. Everything shares a common safety database, design system, audit trail and governed-AI framework.
PV-01
Intake
Case Intake
The front door for your entire PV system.
Ingests adverse events from every channel — spontaneous, literature, clinical trial, social media, partner companies and health authorities — then de-duplicates, triages and routes them into a structured queue ready for processing.
Multi-channel Intake
Duplicate Detection
Triage & Routing
E2B Import
PV-02
ICSR
ICSR Case Processing
A full-featured safety database for the complete case lifecycle.
Covers intake, data entry, medical review, MedDRA coding, narrative generation and E2B(R3) submission — with AI drafting narratives and proposing codes, and qualified reviewers accepting every regulated step.
MedDRA Coding
Medical Review
Narrative Generation
E2B(R3)
PV-03
Crypta
Literature Review & Monitoring
Automated systematic literature monitoring for GVP Module VI.
Structured searches across PubMed, Embase and proprietary databases, AI-powered relevance screening, and a defensible, audit-trailed record of every decision — so weekly and periodic literature obligations stop being a manual grind.
PubMed / Embase
Relevance Screening
GVP Module VI
Audit Trail
PV-04
Signum
Signal Detection & Management
Quantitative signal detection, with a lifecycle that holds.
Disproportionality analysis (PRR, ROR, EBGM) across your safety database, combined with a structured signal-validation and lifecycle-management workflow — from detection through assessment, decision and closure.
PRR / ROR / EBGM
Disproportionality
Signal Validation
Lifecycle Tracking
PV-05
Reg Intel
Regulatory Intelligence
Global regulatory change, translated into action.
Monitors authorities continuously — EMA, FDA, CDSCO, PMDA, TGA, Health Canada, Swissmedic and more — and turns each update into an impact assessment and a tracked, owned task instead of an email nobody reads.
Authority Monitoring
Impact Assessment
Actionable Tasks
Change Control
PV-06
RMP
Case Intake
Risk management as structured data, not a document.
Replaces the document-centric model with governed data objects: safety concerns, pharmacovigilance activities and risk-minimisation measures are versioned, linked and reportable — so the RMP writes itself from the data.
Safety Concerns
PV Activities
Risk Minimisation
Structured Data
PV-07
Qualitus
Quality Management System
A purpose-built QMS underpinning the whole suite.
Audits, CAPA, training, the local-PV (LPV) network, messaging, time tracking and analytics — built for pharmacovigilance and life-sciences organisations, with per-tenant configuration and a complete quality record.
Audits
CAPA
Training
LPV Network
PV-08
Materiovigilance
MEDICAL DEVICE VIGILANCE
A purpose-built QMS underpinning the whole suite.
Medical-device vigilance: multi-channel incident intake, Al data extraction, UDI validation, seriousness & reportability rules (MDR Art 87/88, 21 CFR 803), IMDRF report generation, EUDAMED/MedWatch submission, duplicate detection, FSCA linkage, device signal detection and SLA monitoring.
IMDRF / MedWatch
CAPA
UDI Validation
Device Signals
See it in action
Watch each module work.
From case intake to signal closure — short, guided walkthroughs of the workflows your safety and quality teams face every day. Click any card to play.
PV-01 · Demo
Case Intake
PV-02 · Demo
ICSR Case Processing
PV-03 · Demo
Literature Review & Monitoring
PV-04 · Demo
Signal Detection & Management
PV-05 · Demo
Regulatory Intelligence
PV-06 · Demo
Risk Management Module
PV-07 · Demo
Materiovigilance
PV-08 · Demo
Qualitus · QMS
Why one platform
GenAI that accelerates. Governance that protects.
Salvus applies AI where it saves the most time — triage, extraction, coding, drafting — while keeping every regulated safety decision in qualified human hands.
01
Human-in-the-loop by design
AI proposes; qualified reviewers accept. Coding, data changes and milestone actions all pass a human gate — with the AI's contribution logged.
02
Audit-trailed by default
Every action, every AI suggestion and every override is captured in an immutable, 21 CFR Part 11-ready trail — inspection export in one click.
03
One data model
Modules share a common data model, so protocol, supply, capture and lock data flow across the trial without re-keying or reconciliation gaps.
04
Deploy one or all
Adopt a single module standalone, or run the whole suite. Each stands on its own — and gets stronger when connected to the rest.
Built for inspection
Compliant with the frameworks
your auditors expect.
EU EMA / GVP
US FDA
ICH E2B(R3)
MedDRA
21 CFR Part 11
EU Annex 11
GVP Module VI
GAMP 5
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