Overview

Individual Case Study Report (ICSR) standard varies with every product type. In addition, with continuous increase in cases from various sources resulting from research and development, there is always a need to be aligned with improved case processing standards. In such scenarios, to be complied with Health Authority (HA) requirements, organizations might opt for specialized ICSR services.

Freyr Safety team has extensive experience in handling different databases like Aris G, Oracle Argus, Adverse Event Reporting System (AERS), FDA's AERS (FAERS), SCEPTRE, Empirica Trace, Sapphire, Clintrac to name a few of them. Freyr's safety team assists organizations to handle all types of medicinal product/device cases including but not limited to spontaneous cases, literature cases, interventional clinical trial cases, non-interventional clinical trial cases, pregnancy cases, lack of effect cases, compassionate supply and named patient use cases, medication error and overdose cases, abuse or misuse cases and social media cases. As an end-to-end Regulatory service provider, Freyr’s ICSR services include product safety aspects covering from the developmental phase through the post-approval phase. 

 

Freyr Expertise

  • Case triage/ Book-in
  • Case processing
  • Medical review
  • Causality assessment
  • Quality review
  • MedDra coding
  • Case submission to HA
  • Follow-up to the case
  • Call center setup for receipt of adverse event (AE) reports
  • AE reconciliation 
 

Freyr Advantages

  • Single point of contact for the entire range of safety services including ICSR, Aggregate reports, Qualified Person Responsible for PV (QPPV) services, the US Agent services, Signal Detection & Evaluation, database migration, adverse event reconciliation, and local affiliate services
  • Initial kick-off to submissions to HA and handling/addressing HA queries
  • In-depth safety knowledge perfectly integrated with required IT capabilities
  • Expertise in ICSR case management including case triage/book-in, case processing, narrative writing, medical review, quality control and submission
  • Staff with hands-on experience in handling/managing standard and customized safety databases like Aris G, Oracle Argus, Adverse Event Reporting System (AERS), FDA's AERS (FAERS), SCEPTRE, Empirica Trace, Sapphire, Clintrac to name few
  • Expertise in writing aggregate safety documents as per various health authority and submission requirements like Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), Development Safety Update Report (DSURs), Periodic Adverse Drug Experience Report (PADERs), Annual Safety Report (ASRs), Risk Management Program (RMPs), Risk Evaluation and Mitigation Strategy (REMS), any other country specific reports, etc.
  • Expertise in setting up PV systems and processes, PV Database Evaluation, PV Database Validation, Harmonization, writing SOPs and training employees as per local Regulatory requirements in various geographies
  • Experience in conducting mock audits, training on facing inspections, support in preparing Corrective and Preventive Action (CAPA) and remediation activities
  • Extensive experience in PV process harmonization and creation of  Company Core Data Sheet (CCDS) and Core Safety Information (CSI)
  • Experience in tracking safety variations and PV System Master File (PSMF) compliance
  • Defined processes of thorough scientific, medical, editorial and quality control review
  • Timely delivery with the highest standard of quality
  • Expert program and project management support to maintain compliance