Case study - 3
JILFORA CONSULTING
XML Case Data Migration into Safety System Following Product Acquisition
Seamlessly migrate your data - securely and efficiently
Client Overview
A global pharmaceutical company recently acquired the marketing rights to several drug products from another manufacturer. The acquisition included responsibility for historical and ongoing pharmacovigilance (PV) case management for the acquired products.
Implementation Approach
- Duration: 8 weeks (fast-tracked)
- Volume: ~3,200 ICSRs (serious + non-serious)
- Systems: Source: E2B XML's Target: Oracle Argus / ArisG
Challenges
A. Data Transfer via XML (E2B Format)
- The previous Marketing Authorization Holder (MAH) provided ICSR case data in E2B XML format.
- The client was required to ingest this XML data into their safety database (Oracle Argus / ArisG / Veeva).
B. Complexities of XML Case Migration
- Ensuring data conformance to client's system configuration (e.g., product dictionary, license mappings)
- Preserving audit trail and source traceability for regulatory inspections
- Avoiding duplicates, data corruption, or coding mismatches
- Re-submission risks: Ensuring historical cases aren't unintentionally re-submitted to regulatory agencies
Solution
JILFORA led the end-to-end solution for safe and compliant case data ingestion:
1. XML Ingestion Strategy
- Performed a format and schema validation of incoming E2B XML's (R2/R3 as applicable)
- Used the client's safety system (import tools or custom ingestion scripts (Argus ESM, ArisG Gateway, Veeva APIs)
- Applied deduplication logic to prevent duplicate case creation
- Mapped all products/mes/medicinal product terms to the client's safety database
2. Controlled Case Migration
- Executed batch-wise test uploads into a staging environment
- Conducted data reconciliation between source XMLs and ingested safety cases
- Preserved original receipt dates, case narrative integrity, and report submission history
3. Regulatory and Validation Compliance
- Avoided regulatory re-submission by configuring non-reportable import rules
- Documented the entire migration for audit readiness
- Performed IQ/OQ validation for the case ingestion process
Client Testimonials
"JILFORA handled our XML data migration with precision and care. Their deep system knowledge and risk-aware approach spans us total confidence that we were fully compliant and inspection-ready."
RESULTS & IMPACT
Project Efficiency
- DDR successfully migrated off legacy case data with no data loss or format errors
- Seamless integration of new products into the client's PV workflow
Compliance
- Zero regulatory re-submissions due to careful configuration of submission flags
- Client maintained full compliance and audit traceability during Health Authority Inspection