Individual Case Safety Report
An Individual Case Safety Report (ICSR) is a fundamental tool in pharmacovigilance, which is intended to record and disseminate data regarding potential adverse drug reactions (ADRs) or adverse events (AEs) connected to pharmaceutical products. It is the foundation for tracking medication safety over the course of a product’s life.
ICSRs are submitted to health authorities or sponsors by medical professionals, healthcare organizations, patients, or caregivers
Scansio specializes in the management of ICSRs originating from various sources for human and veterinary pharmacovigilance
- Spontaneous
- Clinical/Solicited
- Literature
- Health Authority
- Business Partners (E2B)
- Legal
- Social Media
The quality of case processing of the information obtained from multiple sources is essential for the analysis of risk-benefit profiles and the safe and efficient use of the product, especially in light of the evolving landscape of product types and regulatory requirements.
We have deep expertise in management of activities across the spectrum for ICSRs including:
- Case Intake and Triage
- Case Creation/Duplicate Detection
- Data Entry and MedDRA Coding
- Quality Check
- Medical Review
- Follow-up Queries and Tracking
Our pharmacovigilance operating model combines standard safety databases with our scientific expertise to provide quality, scalable, and technology-driven compliance solutions.