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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 and an array of specialised services.
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ICSR management services by Qinecsa

Extensive ICSR management services, covering collection, triage, data entry, quality review, and medical review, all designed to facilitate the regulatory submission of ICSRs.

Collection

Meticulous gathering of individual case reports detailing adverse reactions, followed by a careful triage to determine the urgency and severity of each event. 

Review

Medical review, a pivotal step, involves the evaluation of cases by qualified healthcare professionals to determine causality, potential risks, and appropriate regulatory actions. 

Reprorting

Regulatory submission of ICSRs, contributing to the overall safety profile of pharmaceutical products. Accurate and comprehensive ICSRs are submitted to regulatory authorities for evaluation and action.