Case study - 1
JILFORA CONSULTING
Automating Safety Data Management & Regulatory Reporting for a Mid-Size Pharma Company
Client Overview
A mid-sized pharmaceutical company with a global footprint and a growing product portfolio across therapeutic areas including neurology and oncology. The client manages an increasing volume of adverse event reports and must comply with complex regulatory requirements from authorities like the FDA, EMA, and PMDA.
Implementation Approach
- Duration: 4 months
- Team: JILFORA PV consultants, safety database administrators, validation engineers, and client SMEs
Approach:
- Requirements gathering & gap analysis
- Agile configuration and iterative testing
- Go-live support and hypercare
Challenges
The client's pharmacovigilance team faced major operational bottlenecks due to highly manual processes:
- Maintaining safety case data manually in Excel spreadsheets
- Generating reports (CIOMS, line listings, PADERS) manually, increasing the risk of errors
- Submitting reports to regulatory authorities through non-standardized processes
- Lack of audit-ready documentation and real-time visibility into safety performance
These inefficiencies led to:
- High compliance risks and missed regulatory timelines
- Increased resource burden for routine safety tasks
- Difficulty scaling as case volumes grew
Solution
JILFORA was engaged to transform the client's pharmacovigilance operations by implementing and optimizing Oracle Argus Safety and associated automation tools.
Key solutions included:
- Data Migration: Transitioned from Excel-based tracking to structured, validated data in Oracle Argus
- Automation of Report Generation: Configured automated generation of CIOMS, DSUR, and periodic reports
- Regulatory Submission Integration: Enabled automated E2B(R3) submissions to global health authorities
- Dashboard Setup: Created real-time dashboards for tracking case processing and regulatory compliance
- Validation & Training: Full system validation (IQ/OQ/PQ) and hands-on user training sessions
Client Testimonials
"Partnering with JILFORA helped us eliminate manual inefficiencies and confidently navigate regulatory reporting requirements. Their team brought deep PV knowledge and seamless execution."
RESULTS & IMPACT
Project Efficiency
- 80% reduction in manual effort across PV case management
- 100% on-time regulatory report submissions post-automation
Complaince
- Zero audit findings in two subsequent regulatory inspections
- Scalable PV infrastructure ready for future growth and compliance needs
Client Satisfaction
- Improved data accuracy and traceability