,Individual Case Safety Report (ICSR) Services - Overview
The complexity of an Individual Case Safety Report (ICSR) can vary with every product and report type. With a continuous increase in adverse drug reaction (ADR Reporting) cases from diverse sources, aligning with evolving ICSR processing standards and regulations is crucial. To meet stringent Health Authority Reporting requirements, many organizations opt for specialized ICSR pharmacovigilance services.
As an end-to-end pharmacovigilance provider, Freyr offers comprehensive support that covers product safety from the developmental phase to post-approval. This is particularly critical for managing data from ICSR in clinical research. A core component of this is our scalable Individual Case Safety Report (ICSR) Services, backed by a safety team with extensive experience handling various databases such as ArisG, Argus, AERS/FAERS, RxLogix’s Safety in a Box, and Clinevo Safety.
Freyr assists organizations in handling all types of cases for medicinal products and devices. Our expertise covers various report types, including spontaneous, literature, interventional and non-interventional ICSR clinical trials, pregnancy, legal, and Over the Counter (OTC) products. We also manage end-of-study unblinding, compassionate use reports, and the expedited reporting required for a SUSAR. This robust case handling is a key component of our Individual Case Safety Report (ICSR) Services.
Individual Case Safety Report (ICSR) Services
Our dedicated teams provide end-to-end support, making our Individual Case Safety Report (ICSR) Services a reliable solution for life sciences companies. We ensure every ICSR is handled with precision through a structured process. With experience in both manual and database based case processing, Freyr offers a range of services.
- Systematic ICSR Intake and ICSR Triage for efficient prioritization of incoming cases.
- End-to-end ICSR processing and complete ICSR management from all data sources.
- Accurate ICSR Data entry followed by the preparation and review of detailed case narratives.
- In-depth ICSR Medical Review conducted by our team of experienced physicians.
- A robust ICSR Quality Review process to ensure the highest levels of data accuracy.
- Standardized coding of adverse events and drugs using the latest versions of MedDRA and WHO DD.
- Timely electronic ICSR Submission to relevant global health authorities.
- Periodic reconciliation activities with partners/ distributors to maintain compliance with SDEAs.
- Diligent follow-up on individual case safety reports to obtain complete and accurate information.
- Support in Individual Case Safety Report (ICSR) management
- Expertise in medical evaluation
- In line and end of line quality assurance
