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Services

ICSR Management

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ICSR Management

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Every case. Every deadline. Every time.

ICSR isn't just a service we offer—it's our core expertise. Our specialists process thousands of Individual Case Safety Reports with a methodology refined over years: structured triage, precise MedDRA coding, airtight narrative writing, and on-time E2B submissions.

What sets us apart? We don't just process cases—we own them. From intake to regulatory submission, our dedicated teams ensure zero backlogs, consistent quality, and full audit readiness. Whether you're managing 50 cases or 5,000, we scale seamlessly without compromising accuracy.

Database flexibility included. Our teams are trained on Argus, ArisG, Veeva Vault Safety, and more — we work within your system, on your license, with zero onboarding friction.

Explore ICSR Insight Blogs
On-time submissions
Audit readiness
Database flexible

Case Processing

End-to-End Case Processing

From intake to submission — zero gaps.

Our structured workflow ensures every case moves through a defined pipeline with built-in quality gates at each stage:

  • 01 Booking & Triage — Incoming cases categorized by seriousness, expectedness, and regulatory timeline.
  • 02 Data Entry & MedDRA Coding — Precise coding using the latest MedDRA dictionary with full version traceability.
  • 03 Narrative Writing — Clinically accurate narratives that reflect the patient's experience and meet regulatory expectations.
  • 04 Quality Review — Dual-layer QC with peer review and senior medical review before submission.
  • 05 E2B Submission — Electronic submission in E2B(R2)/E2B(R3) format to regulatory authorities within mandated timelines.

Database Expertise

Database-Agnostic Expertise

Your database. Your license. Our trained hands.

We work directly within your existing safety database — no separate licenses, no platform switching. Our teams are extensively trained and hands-on experienced across all major safety databases, ready to hit the ground running from day one:

  • Oracle Argus Safety — Experienced in full lifecycle case management, expedited and periodic reporting.
  • ArisG — Proficient in case processing, signal management, and aggregate reporting.
  • Veeva Vault Safety — Skilled in cloud-native case management and compliance workflows.
  • In-House & Legacy Systems — Adaptable to your proprietary or custom-built safety databases with seamless onboarding.
  • Multi-Region Support — Simultaneous submissions to FDA, EMA, MHRA, TGA, and other health authorities.
  • VigiVault — Our In-House Safety Database — Purpose-built by DrugVigil for end-to-end pharmacovigilance, delivering unmatched speed, compliance, and control from day one.

Why Drugvigil

Why Choose Drugvigil for ICSR Management

The reliability your safety database demands.

Case backlogs don't just cause operational headaches — they represent regulatory risk. Missed timelines, inconsistent quality, and under-resourced teams can trigger inspections and audit findings.

Drugvigil eliminates these risks. We provide a dedicated, scalable workforce that integrates directly with your pharmacovigilance system — delivering consistent output regardless of volume spikes.

  • Zero backlog guarantee with scalable team allocation
  • Consistent quality with dual-layer QC on every case
  • Audit-ready documentation and full traceability
  • Dedicated team per client — no shared resources
  • Cost-effective pricing without compromising accuracy