Adverse Event Management
Vigilex is able to manage part or all of the processing phases of Adverse Events from clinical trials and post-authorisation sources: triage, data entry, quality control, MedDRA coding, medical review, reportability assessment, submission (gateway or paper) and follow-up.
Well-trained staff are familiar with global safety databases routinely used by pharmaceutical companies.
Vigilex can support clients with a cost-effective, validated and E2B-compliant, web-based global safety database solution allowing access to their data at all times, whilst enabling worldwide reporting from early clinical trials through the entire product lifecycle.
Vigilex is able to submit expedited reports through an E2B Gateway or EVWEB (Vigilex has certified trainers) and supports clients in the registration process with Eudravigilance including the Extended Eudravigilance Medical Product Dictionary (XEVMPD).
Vigilex is also able to support clients in reconciliation processes e.g. between the clinical database and the global safety database.