Navigating pharmacovigilance challenges in oncology
Case study
Strategic support for seamless data migration and global compliance
Overview
A U.S.-based biotechnology company, focused on oncology and in early-stage development, approached ICON to support the integration and management of three drug assets (one developed internally and two acquired). The company required extensive pharmacovigilance (PV) support, including data migration, comprehensive case processing, and specialised patient safety services. The project scope included a rapid transition to cloud-hosted Veeva Safety database management to support clinical safety and ensure global compliance.
Challenge
The client faced significant operational hurdles:
- Database migration: With no internal PV team, the client had limited resources and knowledge to handle a large-scale data migration of approximately 3,000 cases from acquired assets into the Veeva Safety system.
- Comprehensive case processing: The company required end-to-end case processing support, from data intake to detailed documentation for compliance and audit-readiness.
- Global expansion readiness: To enable rapid clinical growth, the client sought strategic consulting to guide expansion into new regions, particularly in Europe and Asia-Pacific, while ensuring local compliance.
- Specialised safety services: The client needed specialised services, including Development Safety Update Report (DSUR) support, signal detection, and risk management, tailored to their oncology pipeline.
Solution
ICON’s cross-functional PV team crafted a tailored, multi-phase solution:
- Strategic data migration and quality control: ICON’s PV systems team developed a precise, validated plan for data mapping and migration to the Veeva Safety database. This plan included checkpoints and randomised quality controls (QCs) to verify data integrity throughout the process. The team documented each step of the migration to provide the client with a transparent and audit-ready trail.
- Veeva safety database management and maintenance: ICON designed an ongoing support plan for Veeva database management, covering essential maintenance tasks such as dictionary updates, user access controls, system validation, and troubleshooting for global report generation.
- Global safety management and operational framework: The operations team designed a comprehensive Safety Management Plan that aligned with the client's plans for clinical trial expansion. This included preparing compliance protocols for anticipated markets in Europe and Asia-Pacific, ensuring readiness for local regulatory standards.
- Specialised patient safety services: Based on the client's development plans, ICON developed and deployed processes for DSUR preparation, signal detection, and risk management activities to support the sponsor’s patient safety objectives effectively and consistently.
Outcome
ICON successfully positioned itself as a trusted partner, functioning as an extension of the client's resources:
- Enhanced PV operations: ICON enabled a smooth, validated database transition, which has since been fully operationalised. ICON’s thorough documentation process also ensured the client’s readiness for audits and regulatory submissions.
- Global expansion readiness: The Safety Management Plan and PV framework equipped the client to support clinical trial growth into new global markets, with ICON’s team providing ongoing guidance and compliance insights.
- Long-term safety partnership: ICON established a collaborative partnership with the client, continuing to consult on patient safety strategy, compliance, and troubleshooting as safety issues arise, enabling the client to focus on clinical development with confidence.
By addressing immediate needs and anticipating future challenges, ICON provided robust and scalable support, ensuring the client’s pharmacovigilance operations met global standards and were positioned for sustainable growth.