What Is E2B(R3)?
A practical guide to E2B(R3), ICSR data structure, safety reporting workflows, and regulatory submission preparation.
Features
A pharmacovigilance database built to extract adverse events from verbatim, code them in MedDRA, assess causality, control case quality, and support authority submissions while keeping reviewers in control.
AI-Assisted Causality Assessment
Generate consistent, reviewer-controlled causality assessment support from structured case evidence.
Verbatim-to-ICSR Data Entry
Extract adverse events from verbatim narratives and transform them into structured pharmacovigilance cases.
Existing Case Quality Control
Review existing case data and causality assessments for consistency and completeness.
Automated Signal Detection
Monitor safety data with PRR, ROR, IC, EBGM, and time-trend views, then route signals through validation, prioritization, assessment, and action tracking.
Field Evidence
Operational proof points for faster, reviewable pharmacovigilance case processing
85%
Shorter Processing Time
Average treatment time reduced by 85% across 100 pharmacovigilance test cases.
92%
Critical Field Detection
Critical ICSR fields detected correctly before human review.
QC
Structured Quality Review
Automated case quality review across structured checks before validation.
Follow-up
Missing Data Detection
Missing safety information is flagged so reviewers can request follow-up earlier.
Functionalities
AI pharmacovigilance database for event extraction, MedDRA coding, causality assessment, signal detection, quality review, and traceable human validation.
Centralized Pharmacovigilance Database
AI-Assisted Causality Assessment
Verbatim-to-ICSR Data Entry
Existing Case Quality Control
Adverse Event MedDRA Coding
Authority Submission via Electronic Submissions Gateway
Automated Signal Detection
Signal Management Workflow
Signal Detection and Management Module
Signal Detection Metrics
Automate statistical monitoring with PRR, ROR, IC, EBGM, and time-trend analysis for product-event combinations.
AI-Assisted Signal Intelligence
Summarize emerging safety patterns, surface relevant case evidence, and support reviewer-led signal interpretation.
Expectedness and Literature
Support expectedness and labeling review, manage literature evidence, and keep source material linked to signal records.
Signal Workflow Control
Manage validation, prioritization, assessment reports, action tracking, reports, settings, and audit trail in one workflow.
Advanced Technology for a Smarter Pharmacovigilance Database
Verbatim Intake and Structuring
Capture verbatim source data, extract candidate adverse events, and structure reviewable ICSR data.
Centralized Pharmacovigilance Database
Store, retrieve, and manage safety cases in one structured database.
Existing Case Quality Control
The VigiHelp AI engine reviews existing case data and causality conclusions for consistency and completeness.
AI-Assisted Causality Assessment
Generate causality assessment support from timelines, product exposure, event data, and medical context.
Verbatim-to-Case Data Entry
Convert complex verbatim narratives into structured cases with MedDRA-coded adverse events.
Compliance-Ready Outputs
Produce MedDRA-coded adverse event data for CIOMS generation, E2B(R3) workflows, and ESG authority submissions.
Services
Adverse event extraction, MedDRA coding, causality assessment, signal detection, and existing case quality control powered by reviewer-controlled AI support
AI-Assisted Causality Assessment
Generate detailed causality assessment support while keeping the final conclusion under reviewer control.
Case Database Validation
Validate structured case data, causality, and E2B R3 entries against the original verbatim.
Verbatim-to-ICSR Data Entry
Extract adverse events from verbatim, code them in MedDRA, and turn them into structured safety cases.
Authority Submission via ESG
Submit structured regulatory case outputs to authorities through the Electronic Submissions Gateway.
Automated Signal Detection
Track disproportionality and trend metrics such as PRR, ROR, IC, EBGM, and time trend across safety data.
Signal Management Workflow
Coordinate validation, prioritization, assessment reports, follow-up actions, reporting, settings, and audit trail.
Resources
Guides for E2B(R3), MedDRA coding, ICSR submission, and AI pharmacovigilance
MedDRA Coding Guide
How PV teams can handle verbatim review, LLT selection, automated MedDRA coding software, and coding quality control.
ICSR Submission Guide
Steps for preparing Individual Case Safety Reports for ESG, EudraVigilance, E2B(R3), validation, and case QC workflows.
AI ICSR Processing
How AI pharmacovigilance ICSR processing supports adverse event extraction, structured case data, and human review.
F.A.Q
Frequently asked questions about AI pharmacovigilance workflows
VigiHelp is an AI pharmacovigilance database for case intake automation and ICSR processing. It helps teams convert verbatim narratives into structured cases, support verbatim-to-MedDRA coding, document automated causality assessment support, review existing cases, and prepare E2B(R3), CIOMS, ESG, and EudraVigilance-related workflows.
The VigiHelp AI engine reviews source narratives and proposes structured fields such as adverse events, dates, products, patient details, seriousness indicators, and follow-up points. Reviewers keep control of the final case before downstream reporting.
Yes. VigiHelp supports automated MedDRA coding workflows by suggesting coding outputs from extracted adverse event information. Final coding remains reviewable by qualified users.
E2B(R3) is the ICH standard for electronic transmission of Individual Case Safety Reports. It defines how ICSR data is structured for exchange between companies, partners, and health authorities.
VigiHelp organizes case evidence relevant to causality assessment, including timing, product exposure, event information, medical context, and structured case data. Final conclusions remain under reviewer control.
VigiHelp can review existing case data for consistency, completeness, and alignment with the source narrative. It helps identify missing fields, inconsistent dates, coding issues, and causality conclusions needing reviewer attention.
Contact Us
Get in touch with VigiHelp for more information or support.
Address
Paris
France
Call Us
+33 6 27 31 37 47
Email Us
contact@vigihelp.com
Open Hours
Monday - Friday
8:00AM - 06:00PM