VAXXIUM

SAFETY & PHARMACOVIGILANCE

ECSOR provides medical expertise through an internal EU Qualified Person for Pharmacovigilance (EU QPPV), and constant monitoring/evaluation of the risk/benefit ratio of the product.

01.STUDY SETUP

Preparation of customized drug safety and pharmacovigilance SOPs
Preparation of Safety Management Plan
Registration of Sponsors in the EMEA EudraVigilance database
Registration of the medicinal products in the XEVMPD
XEVMPD information to EudraVigilance via EVWEB
Participation in global safety meetings with the Competent Authorities

02.STUDY CONDUCT

SAE coding, management and Expedited reporting: Collection, Quality Control, Assessment, narrative writing, unblinding and management of ICSRs
MedDRA coding of non-serious AEs
SUSAR submission package for investigators & Ethics committees
Periodic Safety Reporting: Development Safety Update Reports (DSUR) and Periodic Safety
Update Reports (PSURs)

03.STUDY CLOSE-OUT

CIOMS II Line listings management
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