Individual Case Safety Report (ICSR) Services – Overview

Individual Case Safety Report (ICSR) standard varies with every product type. With the continuous increase in ADR cases from various sources resulting from research and development, there is always a need to align with improved ICSR case processing standards and regulations. In such scenarios, to comply with the Health Authority (HA) requirements, organizations might opt for specialized ICSR Pharmacovigilance services in accordance with the adverse event reporting system.

As an end-to-end Pharmacovigilance service provider, Freyr’s ICSR Pharmacovigilance services include product safety aspects from the developmental phase to the post-approval phase. Freyr’s ICSR safety team has extensive experience handling various databases such as ArisG, Argus, AERS/FAERS, RxLogix’s Safety in a Box, and Clinevo Safety.

Freyr also assists organizations in handling all types of medicinal product/device cases and various report types, including but not limited to spontaneous, literature, interventional & non-interventional clinical trial, pregnancy, legal, Over-the-Counter (OTC) products, end of study unblinding, compassionate supply, and named patient use reports.