Blended FSP-FSO model powers global expansion for Chinese Biotech

In 2023, a leading China-based biotech company partnered with ICON to launch a global programme for a flagship asset. Building on a six-year strategic relationship and proven success in China, the client sought to expand into the US and Europe while maintaining operational efficiency, oversight, and cost control. ICON configured a blended model, leveraging FSP in China and the US to compliment the customer’s desired core competencies. Full service support was implemented in Europe to align with the client’s regional needs and strategic ambitions.

The client faced mounting pressure to achieve profitability while preparing to launch its first global programme. Several operational hurdles stood in the way:

• Past inefficiencies in the US: The FSO model previously led to delays, limited control, and unpredictable costs.
• No prior experience in Europe: This would be the client’s first study in the region, with no local entity or operational infrastructure.
• Fragmented vendor landscape: Managing multiple vendors in the US created redundancies and diluted accountability.
• Need for scalability: A global model was required that could deliver speed, oversight, and cost efficiency while scaling across diverse geographies.
• Governance gaps: Integrating different delivery models demanded a unified framework to ensure consistency and minimise risk

ICON proposed a blended delivery model tailored to the client’s operational maturity in each region: 

China

• Well-established functional management framework, deeply embedded within client operations.
• Continued use of ICON’s established FSP model, where CRAs had consistently achieved 100% on-time delivery with high quality.

United States

• Extension of the FSP model, leveraging the client’s existing infrastructure and ICON’s embedded management team and senior leadership.
• Built on the governance and management framework successfully established through the China FSP partnership between ICON and the client.
• Improved control, cost predictability, and operational continuity.

Cross-Regional Governance 

To ensure cohesion and integration across delivery models, ICON implemented a consolidated oversight structure:

• A single Alliance VP provides clear and accountable leadership across the partnership sourcing models.
• Regular governance meetings with the client ensured strategic alignment and transparent progress tracking.
• Internal cross–service line check-ins ensured delivery consistency and proactive issue resolution.
• A “one team” culture was supported to foster collaboration and shared accountability

ICON’s blended model delivered a scalable, regionally tailored framework with unified oversight and measurable impact:

• Operational excellence: 100% retention of the newly established US FSP team in 2024; all milestones met across US and EU studies. China continued to demonstrate strong delivery performance and team stability.
• Quality assurance: No major findings in audits, reflecting strong execution and compliance.
• Cost efficiency: The US FSP study achieved an 18% cost reduction, validating the model’s financial effectiveness.

ICON’s blended model delivered a scalable, regionally tailored framework with unified oversight and measurable impact: