- AI in PV
- AI Implementation
- AI Training
- AI Compliance
- Regional Coverage
- Expertise
- QPPV Services
- Medical Safety
- Aggregate Reports
- Signal and Risk Management
- Audits and Due Diligence
- Training and Consultancy
- Digital Transformation
- Technology
iVigee’s experts provide strategic advice and risk management services in a broad range of areas for your safety-systems-related operations, applying decades of experience and utilizing our platforms and systems such as iViReg, our cutting-edge regulatory intelligence tool for true global compliance.
Automation tools for case intake, including our new iViMedic call processing solution.
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.
Oracle Argus 8.4.x upgrade for continued support.
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 visualisation 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.
Whatever your safety database requirements, our expert Argus team can provide both consultation and a solution.