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/ ICSR
ICSR Case Processing
From triage to submission — every case, every regulation, on time.
Salvus ICSR is a full-featured safety database and case processing system covering the complete ICSR lifecycle: intake, data entry, medical review, MedDRA coding, narrative generation, causality assessment, and E2B(R3)/R2 submission to regulatory authorities worldwide.
< 15 days
Expedited case SLA
100+
Regulatory authority gateways
E2B(R3) & R2
Submission formats
MedDRA 27.x
Current dictionary
Key capabilities
End-to-end Case Processing
MedDRA Coding
Narrative Generation
Causality Assessment
E2B(R3) / R2 Submission
Follow-up Management
What it does
All the capability, none of the complexity.
Salvus ICSR is a full-featured safety database and case processing system covering the complete ICSR lifecycle: intake, data entry, medical review, MedDRA coding, narrative generation, causality assessment, and E2B(R3)/R2 submission to regulatory authorities worldwide.
01
End-to-end Case Processing
Structured case data entry across all ICH E2B fields. Configurable workflows per case type. Parallel processing with section locking.
02
MedDRA Coding
Integrated coding with AI-suggested preferred terms for verbatims. Coder adjudication required for non-exact matches. Recoding impact report on dictionary upgrades.
03
Narrative Generation
AI-drafted case narratives in ICH-recommended structure, with evidence citations. Medical reviewer accepts, edits or regenerates — every change tracked.
04
Causality Assessment
Configurable causality algorithms (WHO, Naranjo, Bradford-Hill) with structured documentation of rationale for each drug-event combination.
05
E2B(R3) / R2 Submission
Direct electronic submission to EudraVigilance, FDA FAERS, PMDA, Health Canada and 80+ authorities. Transmission receipts and ACK handling.
06
Follow-up Management
Structured follow-up request generation, response tracking and case update management. Follow-up narrative automatically integrates new information.
07
Periodic Safety Reports
Aggregate case data exports for PSUR, PBRER and DSUR preparation, with line listings and summary tabulations.
08
Regulatory Dashboard
Real-time submission status per authority, case age distribution, SLA adherence and expedited-case pipeline — per product and portfolio.
How it works
From day one to every day after.
A typical journey through ICSR Case Processing — from onboarding to steady-state operations.
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Intake & triage
Case arrives from Salvus Intake with receipt timestamp. Data entry begins immediately; regulatory clock confirmed.
Medical review
Medical officer reviews narrative, coding and causality. AI-drafted narrative sections reviewed and accepted or modified.
Quality check
QA reviewer applies configured checklists. Open findings block submission; closed findings retained as quality records.
Submission
E2B(R3) payload transmitted to appropriate authorities. Receipt and acknowledgement stored. Follow-up cycle managed to closure.
See It in Action
Watch Clinical Trial Management System in action.
A guided walkthrough of the key workflows — built for Pharmacovigilance teams who need to see it to believe it.
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How to add your demo video
1. Upload the ICSR Case Processing demo to YouTube.
2. Copy the video ID from the URL — the part after watch?v=
3. In the HTML above, find: data-vid="PASTE_VIDEO_ID_HERE"
4. Replace PASTE_VIDEO_ID_HERE with your actual video ID.
5. Save & deploy — the play button handles the rest automatically.
Integrations
Connects where you need it to.
ICSR Case Processing is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.
Intake
Multi-source case receipt
Crypta
Literature-sourced case creation
Signum
Case data feeds signal detection
RMP
Safety concerns from validated cases
Compliant with
ICH E2B(R3)
GVP Module VI
21 CFR §312.32
EudraVigilance specs
21 CFR Part 11
MedDRA 27.x
See ICSR Case Processing in a live demo.
Walk through a real workflow with a Tesserblu subject-matter expert.
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