Problem Statement
Pharmacovigilance teams often face delays in case processing and regulatory submissions due to:
- Manual data entry and validation activities
- Data received in multiple formats (XML, Excel, PDF, etc.)
- Complex submission requirements for different regulatory authorities
These inefficiencies lead to increased turnaround time, compliance risks, and operational burden.
Solution: PvEdge® Suite
PvEdge® is an integrated Pharmacovigilance automation platform designed to streamline end-to-end case management — from intake to submission.
Key Functionalities
Automated Case Intake
Extracts and structures data automatically from XML, Excel, and other supported formats.
Minimizes manual data entry errors and improves data consistency.
Minimizes manual data entry errors and improves data consistency.
Smart Case Validation & Routing
Performs duplicate checks using configurable business rules.
Routes valid cases for further medical and regulatory review.
Routes valid cases for further medical and regulatory review.
Regulatory Submission Automation
Supports compliant E2B(R3) submissions to EMA, USFDA, MHRA, and other health authorities.
Ensures traceability and audit readiness.
How it Benefits
Reduced case processing time through automation
Improved accuracy and compliance with global regulatory standards
Faster turnaround for safety case submissions
Operational efficiency and reduced manual workload
Business Impact
By leveraging PvEdge, organizations achieve:
Up to 60% reduction in manual effort
Accelerated submission cycles
Enhanced regulatory compliance with real-time validation and submission tracking