FAQ
Pharmacovigilance FAQ for Case Intake Automation, MedDRA, E2B(R3), and ESG Workflows
Long-tail answers for pharmacovigilance teams evaluating automated case intake, verbatim-to-case processing, verbatim-to-MedDRA coding, automated causality assessment, case quality control, and regulatory submission preparation
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 regulatory workflows such as E2B(R3), CIOMS, ESG, and EudraVigilance-related processes. Signal detection and signal management are also available as platform capabilities.
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: they can confirm, edit, reject, or complete every suggested field before downstream reporting.
An ICSR is a structured safety case describing a suspected adverse event or reaction in an individual patient. It connects source information, reporter and patient details, suspect products, adverse events, seriousness criteria, outcomes, narrative text, coding, and assessment data.
VigiHelp identifies candidate adverse events in unstructured source text, keeps the original verbatim available for traceability, and converts the relevant information into reviewable case fields. This helps teams reduce manual transcription while preserving the evidence needed for pharmacovigilance review.
Yes. VigiHelp supports automated MedDRA coding workflows by suggesting coding outputs from extracted adverse event information. Final coding should remain reviewable by qualified users, especially for serious cases, ambiguous verbatim, complex medical histories, or terms that affect regulatory reporting.
Teams should compare each suggested term with the source phrase, review the selected LLT and resulting PT, confirm that no diagnosis was inferred without support, and apply documented coding conventions. VigiHelp is designed to support that review rather than hide the coding rationale.
Yes. VigiHelp includes an automated signal detection module that helps teams screen product-event combinations, review statistical signal metrics, inspect time trends, and keep the final interpretation under qualified human control.
The signal detection module can surface PRR, ROR, IC, EBGM, and time-trend views. These metrics support prioritization and review; they should be interpreted with clinical context, case quality, expectedness, labeling, and literature evidence.
VigiHelp supports signal validation, prioritization, assessment report preparation, action tracking, AI-assisted signal intelligence, expectedness and labeling review, literature evidence management, reports, settings, and audit trail.
E2B(R3) is the ICH standard for electronic transmission of Individual Case Safety Reports. It matters because it defines how ICSR data is structured for exchange between companies, partners, and health authorities, reducing ambiguity during validation and submission workflows.
VigiHelp supports structured case preparation for E2B(R3), ESG, and EudraVigilance-related workflows. Teams still need to manage authority-specific configuration, validation, testing, acknowledgements, and final submission responsibilities according to their regulatory procedures.
No. VigiHelp is designed as review support for pharmacovigilance teams. Human reviewers remain responsible for case validity, medical judgment, MedDRA coding approval, causality interpretation, follow-up decisions, and final submission readiness.
VigiHelp organizes case evidence relevant to causality assessment, including timing, product exposure, event information, medical context, and structured case data. The VigiHelp AI engine can draft assessment support, but final conclusions should be reviewed and approved by qualified users.
VigiHelp can review existing case data for consistency, completeness, and alignment with the source narrative. It helps identify missing fields, inconsistent dates, duplicated information, unresolved coding issues, and causality conclusions that require reviewer attention.
VigiHelp supports CIOMS-oriented workflows by structuring adverse event, patient, product, narrative, and assessment data needed for case documentation. The exact output and review process should be aligned with each organization's reporting procedure.
VigiHelp is designed for privacy-conscious pharmacovigilance operations with tenant separation, controlled access, encrypted database storage, and a policy that customer data is not used to train the VigiHelp AI engine.
Yes. VigiHelp can support quality control for existing cases by comparing structured data and causality conclusions against source information and review rules. This is useful for case migration, reconciliation, backlog review, and pre-submission cleanup.
VigiHelp is intended for pharmacovigilance teams, drug safety operations, biotech and pharmaceutical companies, service providers, and organizations that need structured safety case processing with AI-assisted intake, coding support, case QC, and regulatory workflow preparation.
A practical evaluation should use representative narratives, serious and non-serious cases, follow-up cases, ambiguous reports, legacy case samples, and target regulatory workflows. Teams should measure extraction accuracy, coding review effort, quality findings, traceability, reviewer acceptance, and time saved per case.