We manage the complete individual case safety report lifecycle — from intake through to regulatory submission — with rigorous quality control at every stage.
Case Receipt & Validation
Comprehensive intake and validation of ICSRs from all sources, ensuring completeness and regulatory compliance from the outset.
Medical Review
Expert medical review of cases by qualified healthcare professionals to assess causality, seriousness and expectedness.
Case Narrative Writing
Preparation of clear, concise and regulatory-compliant case narratives for submission to authorities and partners.
Quality Control
Rigorous quality control checks at each stage of case processing to ensure accuracy and audit readiness.
Regulatory Submission
Timely electronic and paper submission of ICSRs to global and local health authorities, including E2B and CIOMS formats.
Reconciliation & Follow-up
Ongoing reconciliation of cases with partners and follow-up with reporters to ensure data integrity and completeness.
Aggregate Reporting Support
Support for aggregate safety report preparation, including PSURs, DSURs and PADERs, using processed case data.
Training & Process Optimisation
Continuous training and process improvement to maximise efficiency, compliance and quality in case processing.
