Argus System Management and Hosting

Applying system best practices to address your specific business challenges, we will expertly configure your Argus Safety Database to meet your current needs and ensure its scalability as your business grows.

We build and manage systems with iterative, intuitive workflows and reporting for your pre- and post-marketing activities, saving time and improving access to data, so you can make faster, more informed pharmacovigilance safety decisions. In addition, we provide complete regulatory inspection support — on site if necessary.

When iVigee manages your system, you’ll see improved efficiencies with features such as:

• Custom auto-population of case narratives, letter generation and information requests to ensure data consistency and reduce error.
• Case prioritization rules to identify reportable cases, AESI, and supporting imposed additional PV activities.
• Custom E2B profile mapping, gateway architecture and edit checks to align with regulatory requirements.
• Global expedited reporting rules and automated distribution to eliminate manual effort.
• 21 CFR Part 11/Annex 11-compliant change control, including automated functional requirement specification (FRS) refresh.
• Regulatory inspection support and system validation defence.
• Dedicated help desk with rapid response and troubleshooting from staff with technical and operational (drug safety) experience.
• Wide selection of choices for integration with your IT ecosystem, including SSO, MS Azure and AWS solutions

Argus System Hosting

When you host your Argus system with iVigee you can be sure of guaranteed up-time, with secure, worry-free reporting. iVigee’s secure Argus hosting platform provides instant access to critical pharmacovigilance data analytics and compliance reporting without the burden of building and managing your own. And with industry-leading cybersecurity, your data is always safe and secure.

Our flexible, scalable solution includes:

• Cloud infrastructure with advanced security services including intrusion detection, log monitoring, threat intelligence and security analytics.
• Implemented, validated, and managed Argus Safety Suite infrastructure, including periodic upgrades at your request.
• Support by highly experienced engineers, including database tuning/optimization and upgrades.
• Dashboards for quick access to details.
• Disaster recovery including insulated, dedicated sites.
• Firewall maintenance: Database access via virtual private network (VPN) for additional security and privacy.

Advanced data visualisation.

As recognised experts on Argus and the use of technology in pharmacovigilance, we have additionally developed our iViSight analytics system to provide a complete data visualization solution, allowing you to extract the most from your safety data and uncovering signals and potential issues before they become a problem.