Comprehensive intake and validation of ICSRs from all sources, ensuring completeness and regulatory compliance from the outset.
Expert medical review of cases by qualified healthcare professionals to assess causality, seriousness, and expectedness.
Preparation of clear, concise, and regulatory-compliant case narratives for submission to authorities and partners.
Rigorous quality control checks at each stage of case processing to ensure accuracy and audit readiness.
Timely electronic and paper submission of ICSRs to global and local health authorities, including E2B and CIOMS formats.
Ongoing reconciliation of cases with partners and follow-up with reporters to ensure data integrity and completeness.
Support for aggregate safety report preparation, including PSURs, DSURs, and PADERs, using processed case data.
Continuous training and process improvement to maximize efficiency, compliance, and quality in case processing.