Comprehensive ICSR Management for Global Compliance

Individual Case Safety Report (ICSR) management covers the full case lifecycle: receipt, duplicate checks, data entry, MedDRA coding, medical review, follow-up, regulatory submission in ICH E2B(R3) formats, and archiving. Global compliance means regional clocks, destination rules, and partner exchange obligations all have to work from one controlled process. Case quality is medical and operational at once; thin narratives and late follow-up undermine both signal detection and inspection defense.

Viltis supports ICSR operations and system process design for clinical and post-marketing cases. We help define case processing SOPs, quality checks, metrics that surface backlog and error patterns, and handoffs with affiliates or safety vendors. When databases and gateways are involved, including EudraVigilance routes where applicable, we align procedures to how the system actually behaves, not only to a flowchart. Migrations and vendor transitions get special attention because case history and clock continuity are easy to break.

Quality control should catch medical and process errors without becoming a second full case process. We help design sampling QC, targeted checks for high-risk cases, and feedback loops into training when the same coding or narrative defects recur. Metrics then measure improvement rather than only throughput, which is how case operations stay inspectable under growth. Affiliate and partner case exchange agreements are reviewed so clocks and minimum data sets are unambiguous before volume rises.

ICSR management work commonly includes

• Full-lifecycle case processing SOP design
• E2B(R3) submission process and QC checks
• Duplicate management and follow-up strategies
• Medical review and narrative standards
• Vendor oversight and case quality audits
• Metrics for timeliness and coding quality
• Migration and reconciliation support between systems

Clean ICSR management protects patients and keeps aggregate reporting honest. We help organizations process cases with consistent medical judgment and submission discipline, without pretending volume alone equals a functioning PV system. When backlog or quality debt exists, we help triage by risk so the most consequential cases move first while the process is repaired. If case backlog or quality debt is growing, we help stabilize medical review and submissions first, then harden SOPs and metrics so the problem does not return.