VigiHelp is a pharmacovigilance platform with two connected products: VigiHelp Database for structured safety case operations and VigiHelp QC for AI-assisted case quality control at enterprise scale.
Process ICSRs from source narratives, support MedDRA coding and causality assessment, manage structured case data, and prepare regulatory-ready workflows with traceable human validation.
Help big pharma and safety operations teams review processed case quality with configurable business rule templates, AI-generated QC reports, reviewer decisions, and inspection-ready traceability.
Generate consistent, reviewer-controlled causality assessment support from structured case evidence.
Extract adverse events from verbatim narratives and transform them into structured pharmacovigilance cases.
Review processed cases with configurable AI business rules, random QC sampling, and traceable reviewer decisions.
Monitor safety data with PRR, ROR, IC, EBGM, and time-trend views, then route signals through validation, prioritization, assessment, and action tracking.
Operational proof points for faster, reviewable pharmacovigilance case processing
Average treatment time reduced by 85% across 100 pharmacovigilance test cases.
Critical ICSR fields detected correctly before human review.
Business rule templates drive consistent AI-assisted QC checks before reviewer sign-off.
Missing safety information is flagged so reviewers can request follow-up earlier.
AI pharmacovigilance platform for event extraction, MedDRA coding, causality assessment, signal detection, configurable QC review, random sampling, and traceable human validation.
Automate statistical monitoring with PRR, ROR, IC, EBGM, and time-trend analysis for product-event combinations.
Summarize emerging safety patterns, surface relevant case evidence, and support reviewer-led signal interpretation.
Support expectedness and labeling review, manage literature evidence, and keep source material linked to signal records.
Manage validation, prioritization, assessment reports, action tracking, reports, settings, and audit trail in one workflow.
Capture verbatim source data, extract candidate adverse events, and structure reviewable ICSR data.
Store, retrieve, and manage safety cases in one structured database.
The VigiHelp QC AI engine reviews processed case data against configurable business rules for consistency, completeness, and procedure alignment.
Generate causality assessment support from timelines, product exposure, event data, and medical context.
Convert complex verbatim narratives into structured cases with MedDRA-coded adverse events.
Produce MedDRA-coded adverse event data for CIOMS generation, E2B(R3) workflows, and ESG authority submissions.
Adverse event extraction, MedDRA coding, causality assessment, signal detection, configurable VigiHelp QC, and random sampling powered by reviewer-controlled AI support
Generate detailed causality assessment support while keeping the final conclusion under reviewer control.
Validate processed case data, causality, coding, and source consistency against configurable QC business rules.
Extract adverse events from verbatim, code them in MedDRA, and turn them into structured safety cases.
Submit structured regulatory case outputs to authorities through the Electronic Submissions Gateway.
Track disproportionality and trend metrics such as PRR, ROR, IC, EBGM, and time trend across safety data.
Coordinate validation, prioritization, assessment reports, follow-up actions, reporting, settings, and audit trail.
Guides for E2B(R3), MedDRA coding, ICSR submission, and AI pharmacovigilance
A practical guide to E2B(R3), ICSR data structure, safety reporting workflows, and regulatory submission preparation.
How PV teams can handle verbatim review, LLT selection, automated MedDRA coding software, and coding quality control.
Steps for preparing Individual Case Safety Reports for ESG, EudraVigilance, E2B(R3), validation, and VigiHelp QC workflows.
How AI pharmacovigilance ICSR processing supports adverse event extraction, structured case data, and human review.
Frequently asked questions about AI pharmacovigilance workflows
Get in touch with VigiHelp for more information or support.
Paris
France
+33 6 27 31 37 47
contact@vigihelp.com
Monday - Friday
8:00AM - 06:00PM