About Client
A leading pharmaceutical manufacturer headquartered in India, recognized for its robust global operations and a strong commitment to regulatory compliance in drug safety. The company manages complex pharmacovigilance workflows across international markets, including the stringent requirements of Health Canada.
Faced with the challenge of handling Canada Vigilance reports manually—often spending hours extracting and interpreting data from unstructured Excel and PDF files—the client sought a faster, smarter solution.
Hassel
Unstructured Source Data
Canada vigilance cases were received in varying formats via PDF, making it difficult and time-consuming to extract relevant AER information accurately.
Slow, Manual Workflows
Processing even a small volume of cases required significant manual effort, increasing turnaround time and the risk of human error.
Compliance Pressure
Users needed a reliable and compliant system that could support Health Canada’s requirements while improving internal data quality and traceability.
Expectation of Simplicity
Users were looking for a user-friendly interface that could automate key steps and reduce their operational burden without a steep learning curve.
Tackling the Challenges
Implementation of PvXtract v1.0.0
The organization implemented PvXtract® — a purpose-built solution to extract, process, and convert Canada vigilance reports into ICH E2B R2 XML format with minimal manual involvement.
Smart Workflow Configuration
A role-based workflow allows initiators to validate, modify, and approve/reject cases with comments — all while ensuring audit trail visibility and compliance.
Automated Data Extraction
The system now extracts data from Health Canada Excel and PDF reports, automatically linking it to internal drug dictionaries, MedDRA codes, and company products.
Seamless System Access
Users log in using their existing PvEdge® credentials, ensuring a consistent experience and easier system adoption.
Structured Reporting and Exports
With custom filters and export options, users can now generate tailored reports, perform reconciliations, and respond to regulatory queries more efficiently.
Transformation Business Impact
- Faster Case Turnaround: Automation has reduced processing time drastically by eliminating manual entry and enabling batch-level case actions.
- Improved Data Accuracy: Standardized mapping of extracted fields and automated XML generation helps ensure higher data integrity and regulatory readiness.
- Audit-Ready Workflows: All user actions are logged, providing a transparent, traceable record for internal reviews and external audits.
- Simplified User Experience: Minimal training was required due to intuitive workflows and single sign-on access via PvEdge®.
- Better Compliance with Health Canada: With faster, error-free submissions and structured case management, the organization is now better aligned with Health Canada expectations..
About PvEdge® - A Trusted Pharmacovigilance Software
PvEdge® is an advanced AI-enabled, cloud-ready and trusted pharmacovigilance software for safety database management. PvEdge® helps companies manage safety data and stay compliant with regulations. The platform makes tasks like data migration and reporting easier with its simple interface and useful analytics. By connecting different systems, PvEdge® allows organizations to work more efficiently and accurately. With a focus on improving productivity, it helps pharmaceutical companies overcome challenges and remain competitive.