Global and Local Pharmacovigilance Services, since 2008

ICSR management.

Why you need our ICSR Management services.

Managing your Individual Case Safety Reports (ICSR’s) accurately and efficiently is critical to an effective PV System and Arriello provides full support for each step of the ICSR handling process.

Our capabilities include MedDRA and WHO Drug coding, case assessment, and proactive case follow-up to electronic case submission to EMA, MHRA, FDA, etc, and local case submission to Competent authorities.

From collection and translations to data entry, quality check, medical review, regulatory submission, and case follow-up, we’ll manage your safety data and meet all your ICSR requirements.