Case Processing Services
From initial safety report to regulatory submission: reliable, scalable and quality-driven case processing.
Every Case Matters. Every Deadline Counts.
Bpharma supports pharmaceutical and biotechnology companies with comprehensive Individual Case Safety Report (ICSR) management for clinical trials and post-marketing safety, combining experienced PV professionals, structured workflows and regulatory expertise.
Process
One connected case processing workflow
Case Intake and Triage
Safety report collection, validation, duplicate detection and prioritisation
Case Processing & Coding
Data entry, MedDRA/WHODrug coding, case assessment and narrative preparation.
Medical Review
Expert assessment of seriousness, causality, expectedness and clinical relevance.
Quality Control
Independent quality checks, case consistency checks and compliance monitoring.
Regulatory Submissions
E2B electronic reporting, expedited reporting and submissions to relevant authorities and partners.
Follow Up and Reconciliation
Case follow-up, partner reconciliation and safety database updates