Scaling Local Affiliate Support.
Across 25+ Countries.
Client type:
Geography:
Lifecycle stage:
Service area:
Summary.
A pharmaceutical client transitioning from clinical development to post-marketing operations needed to establish sustainable pharmacovigilance (PV) support across more than 25 countries. This transition introduced increased reporting obligations, the need to manage legacy safety data and the requirement for consistent oversight across global and local operations.
Key focus areas included:
- Compliance: Ensuring alignment with global PV regulations and local requirements.
- Process: Establishing scalable, repeatable affiliate support workflows.
- Data: Migrating and maintaining the integrity of legacy safety case data.
Challenges.
- Migration of approximately 1,200 legacy safety cases into a new safety database.
- Expansion from clinical trial activity to full post-marketing PV obligations.
- Requirement to support 25+ countries with localized PV responsibilities.
- Need to establish inspection-ready governance, oversight and documentation.
Arriello’s extensive experience in supporting similar global PV transitions was a key factor in the client’s decision to engage.
Solution.
Arriello implemented a scalable and integrated affiliate support model designed to align global strategy with local execution. Key elements included:
- Deployment of a hosted safety database, including structured migration and validation of legacy data.
- Establishment of local PV coverage across all relevant markets, ensuring compliance with national requirements and integration of:
- Local case processing and expedited reporting;
- Regulatory intelligence and ongoing compliance monitoring.
- Active participation in regulatory inspections alongside the client, providing operational and compliance support.
The model reduced inefficiencies by minimizing hand-offs between global and local teams while improving visibility and control.
Our solution brought the following outcome:
- Successful migration and stabilization of safety operations within the new system.
- Strong performance during regulatory inspection, demonstrating robust compliance and governance.
- Enhanced oversight and coordination between global and affiliate-level activities.
- Expansion of the partnership into broader regulatory and PV support services.
Our Holistic Approach.
Arriello delivered a fully integrated transition, combining data migration, affiliate support and governance into a single operating model that minimized risk at a critical lifecycle stage.
Rather than working in silos, we aligned global strategy with local execution across 25+ countries, ensuring consistent compliance while adapting to country-specific requirements. Our team operated as an extension of the client.
By embedding best-practice processes, validated data migration and scalable affiliate workflows from day one, we created an inspection-ready framework that worked in practice, not just on paper.
The result was a stable, efficient and scalable model that supported immediate operational needs while positioning our client for long-term growth.
Strengthen local compliance, improve global oversight and build scalable affiliate operations with an integrated pharmacovigilance support model.
Contact Arriello today to discuss your global affiliate support requirements.
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