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Medical review of ICSRs

Expert medical review of ICSRs, achieved through thorough analysis and accurate evaluations of events, contributes to the highest standards of drug safety. Qinecsa provides exhaustive medical review services for all categories for clients’ therapies and products.

ICSR management services by Qinecsa

Expert medical reviews of individual case safety reports (ICSRs), achieved through thorough analysis and accurate evaluations of events, contribute to the highest standards of pharmacovigilance and healthcare.

Coding

Our expert medical reviewers verify correctness, accuracy, and completeness of coding of reported terms such as medical history and adverse events to appropriate MedDRA terms to ensure robust medical assessment.

Causality

Medical review entailing meticulous examination of patient’s demography, current and past medical history, concomitant medications, and variables such as time to onset around events to establish causality with suspect therapies.

Pharmacovigilance comments

Our experts review all available data in the ICSRs and frame an SOP driven PV comment summarizing their conclusion pertaining to causality for each event along with the rationale.