“Structured safety narratives from raw case data, in minutes.”

NarrativeIQ reads incoming adverse event data — spontaneous reports, clinical trial SAE forms, literature case reports, and patient complaint records — and generates complete, audit-ready pharmacovigilance case narratives and Individual Case Safety Reports formatted to ICH E2B(R3) standards. MedDRA coding and WHO Drug Dictionary terminology are applied automatically to every case, producing reports ready for expedited submission to FDA, EMA, and PMDA without manual coding steps.

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Agent Details

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IndustryPharma · Life Sciences

Output typeICH E2B ICSRs and case narratives

Data isolation✓ 6 layers

Audit trail✓ Immutable

This agent produces finished work ready for your team’s review and approval. It completes entire workflows — not just suggestions or partial answers.

Features

What NarrativeIQ does.

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Complete ICSR narrative generation

Generates complete Individual Case Safety Report narratives — patient demographics, relevant medical history, event description, suspect and concomitant drug details, causality assessment, and outcome — structured to the ICH E2B(R3) format required by FDA, EMA, and PMDA for expedited and periodic safety reporting.

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Automated MedDRA coding

Applies Medical Dictionary for Regulatory Activities preferred terms, Lowest Level Terms, and System Organ Class codes to adverse event descriptions automatically — eliminating the manual coding step, reducing inter-coder inconsistency, and ensuring MedDRA version currency across your entire case volume.

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WHO Drug Dictionary standardisation

Matches all reported drug names — including trade names, regional brand names, and informal descriptions — to WHO Drug Dictionary preferred names and ATC codes, standardising medicinal product data across all narratives for signal detection and aggregate report consistency.

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Aggregate safety report support

Aggregates individual case data and coding across your case database into structured input for Periodic Safety Update Reports, Periodic Benefit-Risk Evaluation Reports, and Development Safety Update Reports — providing a consistent coded foundation for benefit-risk analysis.

Advantages

Why it matters to your team.

The real operational benefits your team will experience — described in terms of the work you will no longer have to do, and the outcomes you will achieve instead.

Case processing volume scaled without additional headcount

Pharmacovigilance teams face unpredictable case volume surges during product launches, clinical trial reporting periods, and safety signal investigations. NarrativeIQ handles high-volume periods without requiring additional trained PV staff or contractor support.

Consistent narrative quality across all cases and case types

Manual narrative writing introduces quality variation across writers, experience levels, and time pressure. NarrativeIQ applies the same structured, ICH-compliant approach to every case regardless of volume — eliminating the inconsistencies that generate regulatory questions about narrative completeness.

Fifteen-day expedited reporting deadlines met reliably

For serious unexpected adverse reactions requiring 15-day expedited reporting to FDA and EMA, NarrativeIQ generates a compliant, coded ICSR within hours of case receipt — giving your pharmacovigilance team time for clinical review rather than data entry and coding under deadline pressure.

MedDRA coding accuracy and consistency improved

AI-assisted coding applies MedDRA terminology consistently across the full MedDRA hierarchy — reducing miscoding that creates signal detection blind spots and generates regulatory queries about coding inconsistencies in periodic safety reports.