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.
Robust SAE and SUSAR Framework
At Qinecsa, we understand how to build proper, end-to-end SAE and SUSARs solutions throughout the whole clinical product development life cycle. Our SAE processing framework is designed to handle all the steps of adverse event reporting.
From initial receipt and assessment to regulatory submission and follow-up, we carry out streamlined workflows that prioritise accuracy and timeliness. Our experienced safety specialists will review and evaluate each case to establish appropriate classification and reporting in accordance with global and local regulatory requirements.
For SUSARs, the process requires meticulous medical evaluation against reference safety information and regulatory criteria. Our team uses systematic approaches to assess the expectedness of serious adverse reactions and determine reporting obligations. Additionally, we maintain comprehensive knowledge of country-specific regulations to ensure that all SUSARs are reported within mandated timeframes to relevant health authorities, ethics committees, and investigators.
Data Management and Analysis
Qinecsa uses advanced data management systems for comprehensive tracking and analysis of clinical data. We utilise specialised tools and technologies to identify potential safety signals, perform aggregate analyses, and generate in-depth safety reports. This data-driven approach facilitates informed decision-making and proactive risk management from start to finish.
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.
Working with Qinecsa for Your Needs
Ready to improve your safety solutions? Access a dedicated team of pharmacovigilance specialists committed to high quality and timely reporting. With Qinecsa, you benefit from reduced regulatory risk, improved operational efficiency, and the peace of mind that comes from working with a trusted global partner who is committed to the highest standards of evaluating clinical drug safety data.
