Overview

Individual Case Study 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 be aligned with improved case processing standards and regulations. In such scenarios, to comply with the Health Authority (HA) requirements, organizations might opt for specialized Individual Case Study Report (ICSR) services in accordance with the adverse event reporting system.

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

Freyr also assists organizations to handle 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.

 

Freyr Expertise

  • Receipt and Case Triage/Book-in
  • ICSR Case Processing Obtained Through the Adverse Event Reporting System
  • Preparation and Review of Case Narratives
  • Medical Review
  • Quality Review
  • MedDRA Coding
  • Individual Case Study Report (ICSR) Submissions to the Relevant Authorities
  • ICSR Follow-up Management
  • Setting-up a Call Center for Adverse Event (AE) Reporting
  • AE Reconciliation and Analysis of Similar Events
  • ICSR Audit and CAPA Management
  • Tracking Safety Variations and PV System Master File Compliance
  • Defined Processes for Thorough Scientific, Medical, Editorial, and Quality Control Review
  • Timely Delivery with the Highest Quality Standards
  • Expert Program and Project Management Support
  • E2B (R2) and E2B (R3) Conversion of Data with BFC