SAE and SUSAR management
Management of SAE and SUSARs represents the fundamental and crucial elements of clinical safety management. Qinecsa provides comprehensive end-to-end SAE management, supported by our team of experts, an array of specialised services, and technologies.
Comprehensive SAE management services, covering intake, book-in, triage, data entry, quality review, medical review, analysis of similar events (AOSE) with robust follow-ups, facilitating expedited submissions and distribution to third parties.
Mail-box set-up and management
Systematic collection of SAEs and SUSARs including dispatch and receipt of follow-up queries from/to different CROs and sites in a client-specific mailbox governed with appropriate procedures to ensure quality and timeliness.
Review
Data entry, quality review, and medical review of clinical data, including discharge summaries by qualified healthcare professionals and unblinding of SUSARs to determine appropriate regulatory actions.
Reporting
Regulatory submissions and distribution to investigators, ethics committees (ECs), institutional review boards (IRBs) supported by appropriate alert and cover letters to maintain compliance and contribute to the overall safety profile of sponsor therapies.