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.
Streamlining Individual Case Safety Report Management
Individual case safety reports (ICSRs) are vital for pharmacovigilance practices, providing critical safety information that drives patient protection and regulatory compliance. Qinecsa’s ICSR management solutions deliver comprehensive support for pharmaceutical companies, CROs, and life sciences organisations navigating complex processes or situations. From initial case intake through assessment, narrative development, and regulatory submission, we provide end-to-end solutions that enhance safety data collection while reducing operational burden.
Improved ICSR Processing Solutions
Our experienced pharmacovigilance professionals handle the complete ICSR lifecycle. We leverage our deep regulatory knowledge to ensure all safety reports are processed according to the latest global requirements.
Qinecsa also uses state-of-the-art safety database systems and automation tools to streamline ICSR processing workflows. Our solutions help reduce manual effort, minimise processing errors, and accelerate turnaround times. We can work within your existing safety database infrastructure or provide access to our validated systems based on your organisational needs.
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).
Quality-Focused Approach
Quality is at the heart of our ICSR management services. We implement robust quality control measures throughout the case processing workflow, with multiple layers of verification to ensure accuracy and completeness. Our team stays updated on the latest regulatory guidelines and best practices, applying this knowledge to maintain the highest standards in safety reporting.
Working with Qinecsa for Your ICSR Management Needs
Partnering with Qinecsa provides immediate access to pharmacovigilance expertise without the overhead of building an in-house team. Our scalable solutions can adapt to fluctuating case volumes, helping you manage costs effectively while maintaining compliance. Whether you need complete outsourcing of your ICSR processing or support during peak periods, we tailor our services to your specific requirements.
