Clinical trial outsourcing has never been a one-size-fits-all game. Traditionally, companies had to choose between full-service outsourcing (FSO), where a CRO takes control of nearly everything, and functional service provision (FSP), where specific trial functions are outsourced while the sponsor retains oversight. But both models have clear limitations. Full-service outsourcing can be rigid and costly, while a pure FSP approach demands significant internal oversight, making scalability a challenge. This is why many companies are turning to the FSP hybrid model, a structured yet flexible approach that blends operational control with outsourcing efficiency.
This article will explore the meaning of the FSP hybrid model, its benefits in the industry, strategies for efficient implementation, and its future outlook.
What is the FSP hybrid model approach?
The FSP hybrid model combines FSP and full-service outsourcing, allowing sponsors to outsource key trial functions, such as clinical trial monitoring, site startup services, or data management, while keeping strategic oversight in-house. Unlike a purely blended outsourcing model, hybrid approaches can also integrate one or more FSP offerings into an existing or new FSO arrangement, ensuring that sponsors optimize trial execution by tailoring outsourcing strategies to their specific needs.
The benefits of the FSP hybrid model in the industry
The shift toward FSP hybrid models is a response to the limitations of traditional outsourcing. It offers a middle ground, combining the flexibility and cost-effectiveness of FSP with the higher CRO ownership typical of full-service models. This blend ensures operational control and accountability without overwhelming internal teams, making it the best of both worlds for biotech sponsors managing complex clinical trials.
And the industry is taking notice. FSP outsourcing is growing faster than full-service outsourcing, with 35% of companies increasing their use of FSP models compared to 29% for full-service outsourcing. Currently, FSP and hybrid models each account for about 25% of outsourced clinical work, signaling a clear shift toward more adaptable outsourcing strategies*.
With clinical trials becoming more complex and decentralized, sponsors need an outsourcing model that adapts to evolving regulatory landscapes, integrates advanced data solutions, and supports multi-regional trial operations. Hybrid models allows sponsors to customize their outsourcing strategies while maintaining agility, ensuring that critical functions like clinical trial monitoring, site startup, and data management are handled efficiently while keeping essential oversight in-house.
Regulatory complexity is another major driver. Companies operating in CEE and CIS regions, for instance, face unique regulatory landscapes that demand both local expertise and centralized oversight. The FSP hybrid model combinines on-the-ground regulatory support with the efficiency of a scalable outsourcing model.
Implementing an effective FSP hybrid model
So, how is an FSP hybrid model implemented?
The first step is determining which functions to outsource while keeping oversight where it matters. Clinical trial monitoring and data management are commonly outsourced to FSP providers with specialized expertise and scalable resources, while site startup services and regulatory compliance often require internal control to ensure alignment with evolving requirements. Patient recruitment, particularly in niche markets, may benefit from a hybrid approach with internal teams managing feasibility while external partners handle execution. The focus should be on structuring outsourcing in a way that supports trial success, rather than following a predefined model.
Choosing the right partners is critical. Multi-regional trials, particularly in CEE and CIS regions, require FSP providers with regulatory expertise and scalable solutions. The ability to integrate decentralized trial management tools and advanced patient recruitment strategies ensures adaptability as trial needs evolve. A collaborative model, rather than a rigid outsourcing structure, makes the hybrid approach effective.
Seamless integration between internal teams and outsourced functions determines whether the hybrid model delivers its intended benefits. Clear communication channels prevent inefficiencies, and technology-driven solutions, such as real-time data management systems, streamline collaboration. Regular performance reviews keep outsourced functions aligned with strategic goals, ensuring the model remains both effective and compliant.
Outsourcing flexibility should not come at the expense of regulatory compliance. Companies must regularly reassess vendor performance and compliance to ensure that outsourcing decisions remain aligned with industry requirements. With the right balance, the FSP hybrid model can optimize trial execution while maintaining quality and compliance.
Looking into the future
This hybrid model is emerging as a practical, scalable alternative to traditional outsourcing. As clinical trials grow more complex and decentralized, sponsors need a model that adapts to regulatory shifts and supports multi-regional execution. This approach provides the efficiency and oversight necessary to run trials more effectively.
Industry data already shows that FSP outsourcing is expanding faster than full-service models, with hybrid approaches making up a growing share of outsourced clinical work. As companies move away from rigid structures, this model provides the efficiency and adaptability needed to run trials more effectively.
With outsourcing strategies evolving, the FSP hybrid model isn’t just an option but it’s the logical next step for clinical trial management.
*data from ThermoFisher 2024 annual report
