Country in a box - Clinical trial delivery across emerging countries
Case study
Empowering Biotech expansion in emerging markets with customised delivery models
Background
The global clinical research environment is undergoing rapid transformation as biotechnology companies increasingly target emerging markets to broaden access to diverse patient populations, accelerate development timelines, and optimise resource utilisation. ICON has been instrumental in facilitating such expansions through innovative delivery models and robust operational frameworks.
This case study highlights ICON’s successful execution of complex clinical trials in Brazil and the Kingdom of Saudi Arabia (KSA), emphasising tailored strategies, operational excellence, and positive client outcomes. Within an active FSP partnership, ICON proposed an alternative delivery model that allowed the client to retain full operational continuity under a single governance structure.
Country 1 – Brazil
Challenge
A mid-sized biotechnology company, entering the Brazilian market for the first time, engaged ICON to conduct a Phase 2 study investigating APOL1-mediated Proteinuric Kidney Disease. With no prior local experience, the client required a comprehensive, turnkey solution to ensure regulatory compliance, efficient logistics, and seamless study execution. Within the existing FSP framework, ICON implemented a tailored “Country-in-a-Box” leveraging ICON’s Full-Service Outsourcing (FSO), utilising a unit-based approach for resource allocation and cost management, that would remain under ICON’s oversight, avoiding fragmentation across multiple vendors. Challenges included:
- Lack of local expertise: The client’s unfamiliarity with the Brazilian operational landscape posed challenges in
regulatory navigation, site engagement, and patient recruitment. - Regulatory complexity: Brazil’s clinical trial environment is characterised by intricate regulatory requirements,
particularly concerning the import/export of clinical supplies, ethics submissions, and study start-up timelines.
Solution
ICON deployed its “Country-in-a-Box” solution through the FSO division, delivering an end-to-end package that included regulatory strategy, site management, and operational oversight. The unit-based model provided flexibility and transparency for resource utilisation and budgeting, while maintaining alignment with global FSP oversight and reporting.
Outcome
- Efficient study delivery: The project met all regulatory and logistical milestones on schedule.
- Expansion of FSP operations: The initial success enabled ICON to extend its Functional Service Provider
(FSP) footprint in Latin America (LATAM), hiring 32 full-time equivalents (FTEs) to support ongoing and future regional projects. - Establishment of depot facilities: In partnership with World Courier, ICON set up depot operations to ensure
uninterrupted supply availability at study sites. This initiative supports all future clinical trials in LATAM, with ICON overseeing the Importer of Record (IOR) process and managing import/export activities on the client’s behalf
Country 2 – Kingdom of Saudi Arabia
Challenge
ICON was selected to manage a Phase 3b study for patients with transfusion-dependent β-Thalassemia or severe
sickle cell disease in the Kingdom of Saudi Arabia. The project, designed as a single country, single-site delivery,
required precise project management, well-defined roles, and strict adherence to local regulatory and logistical
requirements. Challenges included:
- Regulatory and logistical complexity: The KSA clinical trial landscape involves stringent regulatory oversight and complex procedures for the import/export of investigational products and ancillary supplies.
- Documentation and role clarity: Success depended on comprehensive RACI (Responsible, Accountable, Consulted, Informed) documentation to ensure clear role definition and stakeholder alignment.
Solution
ICON adopted a single country, single-site model under the FSP framework, to maintain tight operational control and effective coordination with local partners. Detailed RACI documentation was developed to clarify responsibilities and ensure accountability. ICON’s regulatory and logistics specialists efficiently navigated the import/export process, securing timely approvals and maintaining supply chain continuity.
Outcome
- Flawless execution: The study was delivered on time and within scope, fulfilling all regulatory and
operational requirements. - Strengthened client relationship: Impressed by ICON’s performance and operational rigor, the client
awarded ICON a second study in the region, reinforcing confidence in ICON’s capabilities in complex
environments.
By integrating alternative FSO delivery models within the FSP framework, ICON facilitated seamless entry into
both highly regulated and emerging markets, such as Brazil and KSA, while preserving unified oversight and
operational continuity. The “Country-in-a-Box” approach, managed entirely under a single FSP governance
structure; demonstrated ICON’s ability to deliver flexible, locally tailored solutions without compromising
consistency, control, or strategic partnership alignment.
Country 3 – Mexico
Challenge
A global biotechnology sponsor decided to enter Mexico for the first time, they faced a significant hurdle: they had no local presence or infrastructure. At the same time, they needed to manage costs carefully, move away from high-cost markets, and ensure scalable support for documentation and regulatory submissions.
Mexico represented a highly attractive market due to its large and diverse patient population, but operational challenges were substantial. The sponsor had no in-country teams to manage ethics submissions, contracts, or engagement with COFEPRIS and sites.
Moreover, the regulatory environment was complex, requiring parallel submissions to multiple authorities, including COFEPRIS and Ethics Committees. Finally, all global study materials needed adaptation to meet Mexican legal, linguistic, and cultural standards.
Solution
ICON proposed a tailored, multi-pronged approach, leveraging the “Country-in-a-Box” model. This flexible solution
combines three key elements to address both operational needs and budget constraints:
- Time & Materials (T&M): On-demand support from SSU specialists and regulatory coordinators to manage
submissions and represent the sponsor locally. - Partial FTEs: Shared resources from ICON’s full service, providing continuity while keeping costs manageable.
- Building on the success of the initial T&M and Partial FTE approaches and recognising ICON’s strong performance in Mexico as well as the cost-effective benefits of a local operation. A dedicated hub was established.
The hub combined Clinical Trial Assistants (CTAs) and Trial Master File (TMF) specialists. CTAs handled study
start-up, site coordination, and document management, while TMF specialists provided centralised oversight,
reconciliation, and audit readiness. This structure now supports multiple studies, delivering both operational
efficiency and regulatory continuity.
ICON also managed the logistics of essential study materials, including binders, USBs, and ensuring they reached
sites seamlessly despite the sponsor’s lack of local infrastructure.
Outcome
The sponsor successfully launched in Mexico with accelerated start-up timelines and no investment in local
infrastructure. Today, the Mexico hub continues to support multiple global FSP programs, delivering cost efficiency, regulatory compliance, and operational scalability. This approach not only enabled smooth first-market entry but also established a sustainable, long-term solution for the sponsor’s ongoing and future studies in the region.
Conclusion
By integrating alternative FSO delivery models within the FSP framework, ICON facilitated seamless entry into both highly regulated and emerging markets, such as Brazil, KSA and Mexico, while preserving unified oversight and operational continuity. The “Country-in-a-Box” approach, managed entirely under a single FSP governance structure; demonstrated ICON’s ability to deliver flexible, locally tailored solutions without compromising consistency, control, or strategic partnership alignment.