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.
Highest Quality Medical Reviews of ICSRs
Individual case safety reports (ICSRs) are the cornerstone of pharmacovigilance, providing critical safety data that informs benefit risk profile of products, regulatory decisions, and patient care protocols. At Qinecsa, we understand that proper medical assessment of these reports requires both scientific rigor and regulatory insight to ensure compliance while prioritising patient safety.
Our specialised medical review services are designed to handle the complex nature of adverse event reporting with precision and expertise. Our team of qualified physicians and medical professionals also brings extensive experience in evaluating causality, determining expectedness, and assessing the medical significance of reported adverse events.
Enhanced Medical Review Process
Qinecsa’s medical review process goes beyond basic compliance requirements to deliver comprehensive safety assessments that add value to your pharmacovigilance operations. Our approach includes:
- Detailed assessments using globally recognised methodologies
- Expert narrative writing that captures critical medical context and rationale
- Thorough evaluation of expectedness against reference safety information
- Specialised review of complex cases
Each ICSR undergoes a systematic review by qualified medical professionals who apply their therapeutic expertise to interpret the clinical significance of reported events. This medical insight is crucial for distinguishing between signal and noise in safety data, enabling more meaningful safety surveillance and risk management.
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.
Working with Qinecsa for Your Needs
Collaborating with Qinecsa for your medical review requirements means gaining access to a flexible, responsive team of specialists who understand both the science and regulations in pharmacovigilance. We tailor our services to your specific needs, whether you’re looking for comprehensive outsourcing of all medical review activities or additional support during periods of high volume.
