Elevate your pharmacovigilance strategy with X Pharma Plus expertise in Individual Case Safety Report (ICSR) management. From case processing to proactive adverse event analysis, our end-to-end approach ensures regulatory compliance and supports safer drug development practices.
Individual Case Safety Report (ICSR) Management Services – Overview
ICSR standards vary across product types, and with the continuous rise in adverse drug reaction (ADR) cases from multiple sources, organizations must align with evolving regulatory requirements for case processing. Specialized ICSR services help companies comply with Health Authority (HA) mandates and maintain robust pharmacovigilance systems.
X Pharma Plus provides comprehensive ICSR services covering the product lifecycle from development to post-approval. Our experienced ICSR safety team is proficient in handling multiple databases, including ArisG, Argus, AERS/FAERS, Rx Logix’s Safety in a Box, and Cline Vo Safety.
We manage all types of medicinal product and device cases, including:
- Spontaneous reports
- Literature cases
- Interventional and non-interventional clinical trials
- Pregnancy cases
- Legal cases
- Over the Counter (OTC) products
- End-of-study unblinding
- Compassionate use and named patient reports
Individual Case Safety Report (ICSR) Management Services
“End-to-end management of adverse event cases from receipt and triage to medical review, quality check, and regulatory submission.”