Comprehensive Safety Platform for Diverse PV Needs

Hosting, configuration, customization, and maintenance of leading pharmacovigilance, medical device vigilance, and cosmetovigilance systems for global and local compliance, adverse events analytics, and insight generation

• Data centers in the US and Europe ensure the highest levels of data protection
• Multi-tenancy models for highly scalable models that are up-to-date with the latest dictionary, feature, and system updates
• Highly experienced techno-functional consultants responsible for creating business rules, custom reporting, data migration support, training, and process optimization

PV-system agnostic solution to capture expedited reporting requirements and determine over-reporting and under-reporting of expedited cases.

• Centralization of requirements gathering from global and local stakeholders to define expedited rules
• Daily report of missed alerts
• Periodic and ad-hoc reconciliation of cases with local safety officers and license partners

Cloud-based web application to automate case reconciliation by comparing safety database listings with vendor/partner listings

• Simple user interface to upload listings
• Report-ready output with a timestamp and user email ID for traceability
• Logs error details and processing history

Automated Mailbox Management Tool to capture and process email attributes to export into a work allocation system

• Email metadata and status are stored for regulatory purposes
• Identify different email types and sort based on subject line variations
• Adapts to increased email volumes

Lightweight tool to capture inputs at the quality review step

• Individual and team-level quality analysis to identify trends
• Automated email notifications to data entry users with a direct link to case findings
• Error categorization

End-to-end authoring of periodic and ad-hoc reports using robotic process automation, vision automation,  and Generative AI

• SME-trained machine models to author report sections
• Automated work allocation based on configurable business rules
• Advanced quality analyses at an author and report level