ICSR case processing and assessment on one audit trail
Move every case through triage, data entry, quality review, and medical review with duplicate detection, follow-up versioning, and assessment logic built in — while the regulated judgments stay with your qualified PV personnel.
Six stages, two human decision gates, one case record
A case does not restart at each stage — it accumulates. Duplicate checks, coded terms, follow-up versions, assessment outcomes, and reviewer sign-offs all attach to the same record, so the history an inspector asks for is already there.
Intake & duplicate check
Inbound reports are matched against the existing case population before anything enters the queue, so the same event is never processed twice.
duplicate detectionTriage & prioritization
Risk-based triage sorts the queue — serious, fatal, and expedited-clock cases surface ahead of routine follow-ups.
risk-basedData entry & coding
Case data is captured across patient, product, event, and reporter domains, with MedDRA and WHO Drug Dictionary auto-coding and manual override.
MedDRA · WHO-DDAssessment
Seriousness logic, causality, and expectedness against the reference safety information are resolved — and recorded with attribution.
human decisionQuality & medical review
A quality review checks completeness and coding consistency; medical review confirms the clinical picture before the case is released.
human decisionRelease to submission
The approved case version is handed to the reporting rules engine, which resolves destination, format, and deadline.
rules engineUnlisted + serious resolves to an expedited obligation. The reporting rules engine picks up the deadline the moment the case is released.
The platform supplies the logic. Your PV personnel make the call.
Seriousness criteria are auto-flagged, causality algorithms are applied, and expectedness is resolved against the version-controlled reference safety information — but every outcome is presented to a qualified assessor to confirm, with the rationale and attribution recorded alongside it.
Deaths, life-threatening events, hospitalisations, and the remaining ICH seriousness criteria are flagged as the case is built.
WHO-UMC and/or a company algorithm, with the reporter's own assessment captured as reported rather than overwritten.
CCDS/CCSI, SmPC, and USPI are held under version control, so a listedness call can always be traced to the datasheet version in force.
Coded consistently, whichever source the case came from
Post-marketing and clinical-trial cases share one platform, one dictionary set, and one audit trail — with study-specific rules, blinding controls, and SUSAR handling applied where they belong.
MedDRA and WHO-DD, under admin control
MedDRA and WHO Drug Dictionary versions are managed centrally by an admin, so every case is coded against a known dictionary version.
Terms are proposed automatically and every one can be overridden by a coder — the override, and who made it, is recorded.
Picklists and dropdown values are configured per tenant from the admin console — no code change to add a market or a study.
SUSARs, blinding, and study-specific rules
Suspected unexpected serious adverse reactions are identified from study cases and routed to expedited handling.
Treatment assignment stays blinded to the processing team until a controlled unblinding step is performed and logged.
Study-specific reporting rules, reference safety information, and expedited criteria are configured per protocol.
What case processing and assessment covers
The full capability set for the processing and assessment stages of the ICSR lifecycle.
Case lifecycle management
- Intake → triage → data entry → quality review → medical review → submission, as one connected workflow
- Duplicate detection before a case enters the queue
- Follow-up tracking and case versioning across every amendment
- Workflow state management with a full audit trail of who changed what, when, and from which value
- Risk-based triage and queue prioritization
Case assessment
- Seriousness and severity logic — auto-flagging of serious cases, deaths, life-threatening events, and other ICH seriousness criteria
- Causality assessment using WHO-UMC and/or a company algorithm, with company and reporter causality captured separately per case
- Expectedness / listedness assessment against the reference safety information (CCDS/CCSI, SmPC, USPI) to drive expedited reporting
- Version-controlled reference safety information management for listedness determination
- Assessment outcomes recorded with attribution and rationale for inspection readiness
Coding & terminology
- MedDRA coding with admin-controlled version management and updates
- WHO Drug Dictionary setup and maintenance from the admin console
- Auto-coding with manual override on every term
- Centralized dictionary and version control through the admin dashboard
- Configurable code lists and admin-managed picklists per tenant
Clinical trial safety
- SUSAR identification and expedited handling
- Blinding / unblinding workflow for clinical cases
- Study and protocol configuration with study-specific reporting rules
- Support for both clinical trial and post-marketing (spontaneous) case sources on the same case record
See case processing on your case types
Request a demo to walk a real case through triage, coding, assessment, and review — with your seriousness criteria, causality algorithm, and reference safety information.