Qinecsa ICSR Management offers comprehensive, end-to-end services and technology for handling Individual Case Safety Reports (ICSRs), forming the cornerstone of a robust pharmacovigilance (PV) system. The solution is designed to simplify and enhance PV processes, ensuring the highest level of safety and global regulatory compliance.
The core of the technology is the Reportum Platform, a unified adverse event platform that manages both digital and analogue initial and follow-up reports across global sources and languages. It provides a digital-first experience for consumers and healthcare professionals, as well as expert pharma users in call centers and other organizations. The platform automates the ingestion of standard PV forms like CIOMS and MedWatch and offers a centralized solution for both legacy and digital workflows.
Key Capabilities:
- Intake & Triage: Systematic collection of adverse events from multiple channels (spontaneous, literature, digital platforms) with automated triage to determine urgency and seriousness.
- Case Processing: Comprehensive services covering data entry, quality review, medical review by qualified professionals, and narrative development.
- Automation & Efficiency: Leverages state-of-the-art safety database systems and automation tools to streamline workflows, reduce manual effort, and accelerate turnaround times.
- Regulatory Submission: Ensures seamless and timely ICSR submissions worldwide, supporting automated E2BR2/R3 transfer into the safety database and maintaining current knowledge of region-specific formats and timelines.
- Data Migration: Provides secure, optimized data migration services for transferring ICSR data from one safety database to another while preserving data integrity and audit trails.
- Literature Screening: Utilizes advanced technology, including AI, to merge expertise with automation for comprehensive global and local literature screening and review, identifying ICSRs and potential safety signals.
Qinecsa's solution is a fully verified and highly scalable SaaS platform, offering flexibility to work within a client's existing safety database infrastructure or provide access to their own validated systems. It is targeted at pharmaceutical companies, CROs, and life sciences organizations seeking to manage fluctuating case volumes and maintain compliance without the overhead of building an in-house team.