ICSR Case Processing
End-to-end individual case safety report handling — intake, triage, MedDRA coding, narrative and E2B submission.
Overview
Timely, high-quality case processing is the foundation of pharmacovigilance and a frequent inspection focus — late or poor-quality reports are among the most common findings. PharmExpert manages the full ICSR lifecycle: intake from all sources, duplicate checking, triage and seriousness/expectedness assessment, MedDRA coding, narrative writing, medical review and regulatory submission in E2B(R3).
Quality is built in at every step. Consistent MedDRA coding, well-written narratives and rigorous medical review determine not only compliance but the reliability of the safety data that feeds signal detection and aggregate reports downstream. We treat case quality as the bedrock it is, not a box to tick.
We operate to defined quality and compliance metrics, with reconciliation against partners and timeliness tracking that keep reporting obligations met across markets. Late-breaking and expedited cases are managed to their regulatory clocks so deadlines are not missed.
The model flexes with your needs — scaling for product launches and volume spikes without sacrificing quality. Whether you need full case processing or surge capacity, you get submission-ready ICSRs and the metrics to prove your reporting is in control.
What we do
- Case intake, duplicate detection and triage
- Seriousness, causality and expectedness assessment
- MedDRA coding and narrative authoring
- Medical review and quality control
- E2B(R3) electronic submission to authorities
- Reconciliation and compliance/timeliness tracking
Our process
- 1
Intake
Receive, log and de-duplicate cases from all sources.
- 2
Process
Assess, code, narrate and quality-check the case.
- 3
Review
Conduct medical review for accuracy and consistency.
- 4
Submit
Transmit E2B and track timeliness and reconciliation.
What you receive
- Processed, submission-ready ICSRs
- Compliance and timeliness metrics
- Reconciliation reports
- Coding and narrative quality standards
Who needs this
MAHs needing scalable case processing, companies launching products, and organizations improving case quality and reporting compliance.
Frequently asked questions
Ready to improve your compliance?
Talk to an independent PharmExpert specialist about your GxP, regulatory or quality challenge. We respond within one business day.