Problem Statement
Pharmacovigilance teams frequently encounter challenges in regulatory aggregate reporting (PADERs, PSURs, DSURs) due to:
- Time-consuming data extraction from multiple systems
- Manual reconciliation of safety data for accuracy and completeness
- Formatting and compilation errors leading to submission delays and inconsistencies
These challenges increase the risk of non-compliance and reporting delays during critical regulatory timelines.
Solution: PvEdge® Document Management System (Reports Module)
The PvEdge Reports Module simplifies and automates the entire aggregate report generation process — from data retrieval to final document compilation.
Key Functionalities
Automated Data Compilation
Seamlessly extracts validated case data from the PvEdge® Safety Database or other integrated sources.
Ensures consistency and eliminates manual data manipulation.
Ensures consistency and eliminates manual data manipulation.
Configurable Report Templates
Supports standard regulatory formats for PADER, PSUR, and DSUR.
Enables customization of templates to align with client or regional requirements.
Enables customization of templates to align with client or regional requirements.
Audit-Ready Document Generation
Automatically compiles data into structured, formatted reports.
Maintains a version-controlled audit trail for traceability and compliance.
Reduces manual intervention while ensuring quality and accuracy.
Maintains a version-controlled audit trail for traceability and compliance.
Reduces manual intervention while ensuring quality and accuracy.
How it Benefits
Faster report generation and submission readiness
Reduced manual effort and human error
Standardized reporting format ensuring regulatory compliance
Improved visibility and control through centralized document management
Business Impact
Up to 70% reduction in report preparation time
Enhanced compliance with regulatory standards
Streamlined collaboration between safety and regulatory teams