Operational support

Argus Services

Operational support

iVigee’s experts provide strategic advice and risk management services in a broad range of areas for your safety-systems-related operations, applying our decades of experience and utilizing iViReg, our cutting-edge regulatory intelligence tool for true global compliance.

Consult with iVigee if you need specialised support for:

Automation tools for case intake, including our new iViMedic call processor.
Fully automated expedited report scheduling and submissions to agencies and partners.
Workflow optimization and case priority design.
Auto-generation of case narratives, integrating case data with preferred text.
Assessing how U.S. and European pharmacovigilance regulations affect system management.
Safety system implementation and change management process oversight.
Argus 8.4.x upgrade for continued Oracle support.

Our iViSight intelligence tool includes:

Periodic benefit-risk evaluation reports (PBRER)
Development safety update reports (DSUR)
Clinical data and product complaint reconciliation reports
Signal detection listings, tabulations and dashboards
Workflow and operational productivity and compliance metrics
Daily or hourly line listings to support workload management and submission compliance
Auto-scheduled recurring reports delivered to target audiences at predetermined intervals
Ad hoc reports with quick turnaround
Experience with various reporting tools including comprehensive visualization of compliance and metrics data via Oracle Business Intelligence Enterprise Edition (OBIEE) dashboards, notifications and alerts.
Rigorous report validation process that ensures all analytic deliverables have been validated via suitable mechanism per intended business use.

Argus Overview

Argus Implementation and Migration

Argus System Management and Hosting

iViSight Safety Database Analytics

iViReg

iViMedic

QPPV – Qualified Person Responsible for Pharmacovigilance

QPPV Office Services