Individual Case Safety
Report ICSR management.
Why you need our ICSR Management services.
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 all concerned parties.
From collection and translations to data entry, quality control, medical review, regulatory submission, and case follow-up, we’ll manage your safety data and meet all your ICSR requirements.
