Individual Case Safety Report (ICSR)
Introducing our Individual Case Safety Report (ICSR) Services: Ensuring comprehensive and accurate reporting of adverse events for enhanced pharmacovigilance and patient safety. ICBio’s ICSR safety team has extensive experience in providing end to end ICSR services and managing various databases, such as ArisG, Argus, AERS/FAERS, and Clinevo Safety.
All Sources (Clinical trials/ Registries/Spontaneous AE/SAES Literature/ HA. Activities include Case validity Duplicate Check Reconciliation/acknowledgment/ Follow Up
Data Entry /Coding Narrative Writing Analysis of Similar Events
100% QC of the Cases Medical assessment Completing analysis of similar events Medical Cohesiveness Completing causality assessment and evaluating listedness/ expectedness of the reported AE
Ensuring timely submission of ICSRS to relevant stakeholders (HAs/Sponsors/ LPs/E2B/EV web/) Follow Up activities
ICBIO provides a fully managed and well-maintained pharmacovigilance safety database services (hosting, servers, implementation, upgradation, maintenance, and support with CLINEVO
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