Ultragenic implemented its Health Authority Integration module of its UltraINGEST Suite, for a US biotechnology company engaged in developing vaccines for emerging infectious diseases, and achieves cost savings of up to 50% with improved data accuracy, speed of case processing, scalability, and regulatory compliances.
The Challenge
As part of their regulatory compliance requirements, they need to perform following on EV WEB portal:
• Maintain search criteria for product portfolios.
• Maintain schedules for downloading cases.
• Perform manual downloads.
• Conduct case review in E2B R3 format (which is not user-friendly).
• Perform duplicate search.
• Discard non-company cases and record the reason for it.
• Conduct periodic reconciliation.
• Ensure audit readiness using excel, tracking sheets, etc.
The current manual process is not only time consuming but also prone to human errors and inaccuracies. Another challenge is of scalability. In times of significant spikes in case volumes, the current team is unable to keep up. Hiring trained and skilled resources to manage the increased work load at short notice is not only a daunting task but also not a plausible solution. This poses regulatory compliance challenges since the cases, once downloaded, need to be reported to the regulatory authorities within a specified time period.
Key Deliverables
• Build-in automation to minimize manual effort
• Free up human resources from repeated tasks to focus on more business-critical functions
• Build capacity and capabilities in the system to handle high case volumes on demand
• Build-in greater accuracy and efficiency in the system
• Meet compliance requirements of regulatory agencies in a timely manner
Our Approach (Solution)
Based on the client’s challenges and our understanding of the key deliverables, we implemented our Health Authority Integration Module. It automates adverse event ingestion to safety systems from varied data sources and formats while maintaining quality and speed. Our solution significantly reduced data entry efforts and effectively solved the challenges associated with their respective data sources.
The Table below illustrates the efficiencies of the Health Authority Integration system by showing a comparison of case processing time for 1 case using a manual process viz a viz the automated solution.
| Process Step | Manual Process (in mins) | Health Authority Module (in mins) |
|---|---|---|
| Log in to EV Web | 2 | Nil (automated) |
| Perform query-based search | 5 | Nil (automated) |
| EV Web processing time to compile files for downloading | 5 | Nil (automated) |
| Triaging (downloading files and file archiving) | 5 | 5 (manual review) |
| Maintain Manual listing | 10 | Nil (automated) |
| Create source document (PDF) for specific cases (XML to PDF conversion) | 15 | Nil (automated) |
| Daily report generation for reconciliations | 15 | Nil (automated) |
The system could handle a case volume of up to 1 million cases daily.
Client Benefits
The Health Authority Integration module has delivered significant productivity gains for the client, while include:
• High Performant system with the capability to ingest cases within minutes into Safety System
• No case backlog due to automated processing
• Uniform intake process for different sources and forms
• Optimized involvement of data entry team
• On-demand scalability to meet unpredictable spikes in case volumes
• High accuracy due to elimination of human-error
• Increased compliance
40% +
Cost Saving
100%
Accuracy
1 M +
Daily Case Volume Capacity
50% +
Reduced Manual Efforts
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