ICSR management
Management of individual case safety reports (ICSRs) represents the fundamental and crucial elements of a pharmacovigilance system. Qinecsa provides comprehensive end-to-end ICSR management, supported by our team of experts, an array of specialized services and technology.
Comprehensive ICSR management services, covering intake, book-in, triage, data entry, quality review, and medical review, all designed to facilitate expedited submissions and exchange of ICSRs with business partners.
Collection
Systematic collection of adverse events from sources such as spontaneous, literature, regulatory and business partners, followed by triage to determine urgency, severity, and seriousness of each event.
Review
Data entry, quality review and medical review by qualified healthcare professionals to perform MedDRA coding, WHO drug coding, narrative writing, seriousness, causality, and follow-up queries to determine appropriate regulatory actions.
Reporting
Regulatory submissions and exchange to maintain compliance and to contribute to overall safety profile of clients’ therapies including drugs, biologics, vaccines, devices, combination products, and ATMPs (advanced therapy medicinal products).