Individual Case Safety Report (ICSR) Services - Overview
Individual Case Safety Report (ICSR) standards vary 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 under 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.
Individual Case Safety Report (ICSR) Services
- Receipt and Case Triage/Book-in
- ICSR Case processing and ICSR case management obtained through the adverse event reporting system
- Preparation and review of case narratives
- Medical review
- Quality review
- MedDRA coding
- Individual Case Safety Report pharmacovigilance (ICSR) submissions to the relevant authorities
- Individual case safety report follow-up/ICSR management
- Setting up a call center for Adverse Event (AE) reporting
- AE reconciliation and analysis of similar events
- Individual Case Safety Report (ICSR) audit and CAPA management
- Tracking ICSR safety variations and PV system master file compliance
- Defined processes for thorough scientific, medical, editorial, and quality control reviews
- Timely delivery with the highest quality standards
- Expert program and project management support
- E2B (R2) and E2B (R3) conversion of data with BFC
- Support in Individual Case Safety Report (ICSR) management
- Expertise in ICSR processing
- Managing ICSR clinical trials in the drug development stage
