The VigiHelp platform contains two connected products: VigiHelp Database for structured pharmacovigilance case processing and VigiHelp QC for AI-assisted quality review of processed cases.
VigiHelp Database supports adverse event extraction from verbatim, MedDRA coding, causality assessment, regulatory-ready outputs, signal detection, and authority submission workflows. VigiHelp QC helps big pharma configure QC rules, generate AI QC reports, schedule random QC, and keep reviewer decisions traceable.
One platform, two products for pharmacovigilance operations: case processing in VigiHelp Database and quality oversight in VigiHelp QC.
Automate case intake from source narratives, support MedDRA coding and causality assessment, maintain structured safety data, and prepare regulatory outputs with human validation.
Review case quality with AI-assisted reports generated from configurable business rule templates, then document reviewer decisions, amendments, and audit trail.
Key modules across VigiHelp Database and VigiHelp QC
Manage cases in one structured database built for retrieval, review, and downstream reporting.
Extract adverse events from unstructured narratives and turn them into reviewable ICSR records.
Generate causality assessment support automatically to accelerate review workflows.
Code extracted adverse events in MedDRA for compliant terminology workflows.
Support compliance-ready outputs for reporting teams that need structured regulatory deliverables.
Submit prepared regulatory case outputs to authorities through the Electronic Submissions Gateway.
Monitor product-event combinations with PRR, ROR, IC, EBGM, and time-trend signal metrics.
Create configurable QC business rule templates and use AI to check processed cases against expected quality outcomes.
Program manual or scheduled random QC on processed cases by vendor, source, seriousness, dates, country, reviewer, and rule template.
Proof points for pilot evaluation and operational rollout
Average processing time reduced by 85% on 100 representative test cases.
Critical fields detected correctly before human review and final validation.
Configurable AI-assisted quality review across processed cases, amendments, vendors, and inspection-readiness checks.
Follow-up needs are detected from missing or incomplete safety information.
From configurable QC rules to random sampling, reviewer decisions, amendment checks, and quality dashboards
Define QC rules, expected results, severity, required status, and reviewer guidance for repeatable quality review.
Generate AI-assisted QC reports with findings, evidence, recommendations, confidence, and reviewer decision capture.
Run ad-hoc or scheduled random QC on eligible processed cases using configurable selection filters and case counts.
Track workload, failed rules, causality issues, amendment outcomes, vendor quality, inspection alerts, and recent QC activity.
Compare original and amended case data to confirm what was fixed, what remains open, and whether regressions were introduced.
Monitor vendor quality scores, failed rule trends, correction time, amendment rate, and regression rate.
Built for pharmacovigilance operations that need traceable, structured outputs
Keep links between source verbatim, extracted adverse events, MedDRA codes, and case outputs.
Prepare adverse event data for teams working with E2B(R3), MedDRA, CIOMS, and ESG submission processes.
Check processed case data, causality conclusions, documents, and source text against configurable QC review rules.
Move from validated case data to Electronic Submissions Gateway delivery within the same operational flow.