Enabling global expansion by establishing an integrated PV system
APCER helped a global pharmaceutical company in establishing a collaborative global pharmacovigilance (PV) governance model; setting up a single safety database and data migration; and ensuring that all the ICSRs were addressed. A standardized and harmonized process was implemented across the clinical teams which enabled better due diligence and 100% submissions of ICSRs on timely basis with no major inspection findings.