Medical reviews of ICSRs are conducted by expert professionals to ensure precise assessment and classification of adverse events. Our team meticulously evaluates each case to provide accurate and comprehensive safety data. Utilizing state-of-the-art tools and methodologies, we detect and analyze adverse events effectively. This rigorous review process aids in the early identification of potential safety signals and supports regulatory compliance.
Ensuring Safety and Efficacy
Rigorous medical review ensures safety & efficacy. Thorough analysis, accurate evaluations, adherence to protocols, & highest standards upheld.
Comprehensive analysis of individual case safety reports
Accurate evaluation of reported events
Adherence to established protocols and guidelines
Upholding the highest standards in pharmacovigilance
Validation of coding accuracy is paramount for robust medical assessment. Our experts meticulously verify correctness, accuracy, & completeness of reported terms, aligning them with appropriate MedDRA terminology.
Causality
Robust causality assessment in medical review. Detailed scrutiny of patient demographics, medical history, concomitant medications, and event onset timing ensures accurate determination of therapy-related effects.
Pharmacovigilance Comments
After meticulous analysis of ICSRs, SOP-driven PV comments offer succinct causality assessments and rationale for each event, ensuring robust pharmacovigilance scrutiny.
