ICON has had a long-standing FSP preferred provider partnership with a global pharma company, with operations in over 50 countries. In 2019, the sponsor sought an FSP solution to support clinical operations. 

The scope of the program evolved and expanded to include additional service lines, transforming from the initial FSP model to a blended outsourcing model that was optimised to meet the customer’s needs during a time of rapid and extensive growth.

Global expansion: The sponsor needed to rapidly scale its team in the EMEA, APAC, and LATAM regions to accommodate pipeline growth. 

Talent acquisition: Accessing qualified professionals for key clinical operations roles such as Clinical Trial Assistants (CTAs), Clinical Research Associates (CRAs), and Clinical Trial Managers (CTMs) was challenging for sponsor due to market competition and talent shortages. 

Operational efficiency: Ensuring operational efficiency while upscaling and downscaling the team to project needs was essential. The sponsor needed flexibility in resource allocation while maintaining control over portfolio deliverables and ensuring effective project management and performance

FSP partnership: ICON provided an insourced FSP partnership in Line Management Model, with the ability to scale resources as needed for efficient management of fluctuating project demands. Control over key trials deliverables remained with the sponsor project management team. 

Tailored recruitment and specialised programs: With a strong understanding of market dynamics and targeted recruitment efforts, ICON ensured a steady supply of qualified clinical operations candidates. Through its dedicated CRA program, ICON addressed and enhanced recruitment and retention efforts in key regions while ensuring continuity of operations. 

Governance and performance: ICON implemented a robust governance structure and KPIs aligned with the client’s objectives to ensure effective performance management and accountability. By adhering to the sponsor’s SOPs and systems, quality standards and operational consistency was maintained.

Effective resourcing: Over 400 resources put in place, primarily focused on CRA, CTM, and CTA roles, with further expansion into study start-up, feasibility, medical advisors, and quality assurance. 

Quality and training: Co-investment in addition of the Quality & Training Advisor to the partnership brough extra value to enhance skillsets and competencies of ICON and sponsor resources. Quality Oversight Visits to CRAs as per the ICON’s Quality Plan further contributed to maintaining high standards of performance and compliance. 

Retention: With a retention rate of 85% and a Total Time to Fill (TTF) of 39 days, the partnership was successful in attracting, retaining, and mobilising talent efficiently. 

Planned expansion: The success of the model prompted a planned expansion to North America, demonstrating scalability and adaptability to meet the sponsor’s evolving needs across different regions and markets.

Language and regional expertise: With a focus on Spanish and Portuguese spoken countries, the sponsor needed Pharmacovigilance (PV) resources with language proficiency and regional expertise. 

Global expansion: As the project progressed, the sponsor needed PV support to expand globally and accommodate the needs of over 50 local affiliates. Ensuring consistent service delivery across diverse regions while maintaining operational efficiency posed a significant challenge. 

Volume fluctuations: There are unstable case volumes at the country level, which complicated resource allocation and operational planning. The sponsor needed efficiently adapt to these fluctuations while ensuring timely and accurate PV activities.

FSP partnership: ICON implemented insourced FSP partnership in Functional Management Model and performs case processing, translations and data entry into sponsor systems. Assigned team is located in LATAM and supports Spanish and Portugese spoken countries. 

Unitized model implementation: ICON introduced a unitized model to optimise workflow management and ensure timely processing of pharmacovigilance cases. Model chosen is hub-based set-up in India to ensure efficient coordination and optimization of the costs.

Resource optimisation: As of today, 30+ FTEs are assigned in FSP model to PV activities with flexibility to upscale and downscale as per sponsor needs. 

Operational efficiency: The implementation of a unitized model and hub-based operations has enhanced operational efficiency, enabling timely processing of PV cases while effectively managing fluctuations in volume. 

Forecasted expansion: With active services in two countries and a forecasted expansion in the future, ICON demonstrated readiness to scale operations to meet the evolving needs. This proactive approach ensures seamless integration of additional countries into the PV network, minimising disruptions and ensuring continuity of service

Rapid growth: The sponsor had significant increase in their pipeline volume, necessitating a scalable and adaptable approach to Data Management, Biostatistics & Programming and Medical Writing. With the forecasted tripling of their pipeline volume, their existing infrastructure could not meet the demands efficiently. 

Resource flexibility: The sponsor required a solution that allowed for quick ramp-up and flexible resource allocation to accommodate fluctuating project needs. 

Transition strategy: Transitioning from a FSP model to a blended Full-Service Outsourcing (FSO) model over a two year period. The client to seamlessly integrate CRO methodologies and technologies while ensuring continuity in service quality and operational efficiency

Blended Solution: ICON offered to rapidly ramp-up the Data Science experts in FSP model to ensure immediate fill of the resource gaps. The next step is gradual evolution into FSO model with assurance of retaining the resource knowledge gained in FSP phase. 

Collaborative partnership: ICON provided a collaborative approach to address the sponsors needs and accommodate future growth with engagement of key stakeholders. 

Performance management: ICON developed a set of Key Performance Indicators (KPIs) aligned with the client’s objectives to ensure effective performance management and accountability in evaluating service quality, operational efficiency, and project outcomes.

Scalable pricing model: With a focus on long-term collaboration, ICON provided a competitive and scalable pricing model, enabling the sponsor to capture benefits from ongoing collaboration and growth, while ensuring cost-effectiveness and budget predictability

Effective FSP resourcing: As of today, 25 FTEs are assigned to multiple roles across all regions, with a target of 50+ placed within 6 months. 

Strategy for FSO implementation developed: ICON performed multiple workshops with sponsor key stakeholders to help them develop tailored solution. It resulted with readiness to transfer into FSO 5+ clinical trials over the next year.