Custom FSP+ model drives sponsor success in new territories
Case study
Overview
A Top 10 biopharmaceutical company sought to expand its clinical trial footprint across Central and Eastern Europe (CEE), including several countries where it had limited or no operational presence. The sponsor’s goal of expansion while maintaining oversight and consistency required more than a traditional Functional Service Provider (FSP) model. ICON designed and executed a custom model that integrates full operational responsibility with embedded governance and local expertise to support a global, multi-vendor FSP client environment.
Challenge
The sponsor faced significant barriers to conducting trials in key CEE countries as they had little or no existing footprint in the region. Across several CEE countries identified for inclusion, the sponsor had little local presence or legal representation. This also meant the sponsor lacked country-specific expertise and local networks important for navigating EC/RA/archiving peculiarities, harnessing key opinion leader (KOL) knowledge, proper recruitment predictability, site landscaping and healthcare infrastructure.
Other challenges included:
- Limited internal clinical operations capabilities, requiring external management of regulatory, operational and vendor-related activities
- Regulatory and submission complexity, especially in markets where harmonised start-up strategies with EU countries could create delays
- Need for strong local governance while adhering to global sponsor SOPs and oversight frameworks
- Growing demands on resources, with local teams often overextended due to additional responsibilities (e.g., subject matter expert roles, training and cross-functional support in non-footprint countries)
Solution
ICON tailored an FSP+ solution that blended dedicated staffing and functional oversight with full service components that were specifically tailored to each country’s needs. Where the sponsor had no legal presence, ICON acted as the sponsor’s legal entity to handle submissions, payments, and site contracts through power of attorney, which provided the necessary legal representation and kept investment costs down.
As the sponsor’s sole partner, ICON collaborated closely and managed all clinical activities that integrated within the sponsor’s infrastructure, providing them the desired level of control and transparency. Our local networks provided the geographical presence and expertise to develop custom, responsive solutions including:
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data-driven strategies
Tailored submission strategies and data-driven forecasting of the study’s success across potential footprint countries aided in high-performing site selection. This provided increased access to target populations required for the study. -
operational ownership
Within the model, ICON staffed all study roles (CRAs, CTAs, project managers) and ensured operations followed sponsor SOPs, ensuring consistency while reducing resource burden.
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governance frameworks
ICON created and maintained custom documents to support the sponsor by providing high level expertise and ensured seamless collaboration in communication pathways, responsibilities, risk-based assessments and escalation procedures. -
resource optimisation
ICON operated out of strategic hubs and centralised teams in local offices to reduce costs, drive better recruitment, improve study management and provide remote oversight to increase efficiency.
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extended oversight
ICON implemented comprehensive support to get the full potential of the allocated teams, including training programs aligned with the sponsor’s needs and tailored line management to ensure sites met the promised deliverables.
Outcome
ICON’s custom FSP+ solution successfully increased the sponsor’s presence in non-footprint countries and diversified the recruitment pools for improved enrolment. Within the expanded CEE region, one non-footprint country (included as a rescue country) became a key contributor with a total of five studies initiated within a year. Furthermore, one of the sponsor’s schizophrenia studies in a CEE country accounted for 10% of global recruitment-demonstrating high performance in low-volume geographies.
By helping the sponsor realise faster startup potential and competitive cost-per-patient rates with integrated legal, strategic and operational functions, the expansion into CEE countries became critical to successful study delivery. The blended model proved to be a powerful, adaptive solution that allowed the sponsor to strategically expand their global research program while maintaining high standards of quality, oversight and operational control.
As a result of this success, the sponsor reported high customer satisfaction scores and nominated ICON multiple times within their global partner recognition program, reflecting our strong collaboration and commitment to operational excellence. We have since expanded our partnership and now run more than 50 trials across the region using this fit for purpose FSP+ model.