Description

At Aepodia, we provide pharmacovigilance services to help you meet the increasingly stringent pre- and post-marketing safety requirements. We work closely with you and your staff to meet your time constraints and quality requirement expectations. Our solutions include: Medical expertise provided by EU Qualified Persons Responsible for Pharmacovigilance (EU QPPV); Electronic reporting of Individual Case Safety Reports (ICSR) using EVWEB; Creation of eXtended Eudravigilance Product Report Messages (XEVPRM) for authorised & investigational medicinal products using EVWEB; Periodic safety reporting: clinical trials Development Safety Update Reports (DSUR) and Periodic Safety Update Reports (PSURs); Scientific casualty assessment and regular monitoring of benefit-Risk assessments; Pharmacovigilance System Master Files (PSMF); SAE coding, management and expedited reporting: collection, quality, control, assessment, narrative writing, unblinding and management of ICSRs; Identification of.

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