What Are FSP Models? A Comprehensive Overview for Clinical Trial Sponsors

2 MIN READ

20 Nov, 2024

Pharmaceutical and biotech companies seek more efficient and cost-effective ways to conduct clinical trials in a climate of intensifying competition. In response, Functional Service Provider (FSP) models in Clinical Research have emerged as a preferred alternative to traditional outsourcing as sponsors are looking for innovative solutions to manage their trials. It allows sponsors to focus on their core competencies while leveraging the expertise of external partners.¹

Understanding the Fundamentals of FSP Models

An FSP model is a type of outsourcing arrangement in which a sponsor engages a contract research organization (CRO) or other service provider to deliver specific functional services for a clinical trial. These services can range from data management and biostatistics to clinical monitoring and regulatory affairs. The key characteristics of FSP models include:

Specialized services tailored to the sponsor’s needs
Flexibility and scalability in resource allocation
Long-term partnerships that foster collaboration and trust
Unlike traditional outsourcing models, where a CRO takes on the entire scope of a clinical trial, FSP models allow sponsors to maintain greater control over the study while benefiting from the expertise and resources of their FSP partners.

Maxis Clinical’s Functional Service Provider (FSP) offerings include important functions, like:

Biostatistics
Statistical Programming
Clinical Data Management
Medical Writing
Clinical Operations & Site Management
Quality Assurance & Compliance

Types of FSP Models

There are several types of FSP models, each designed to cater to the specific needs of sponsors and their clinical trials:

Fully Outsourced FSP Model: In this model, the sponsor outsources a comprehensive range of clinical trial functions to a single FSP partner. This approach streamlines communication and coordination but requires a high level of trust and collaboration between the sponsor and the FSP.
Hybrid FSP Model: A hybrid model combines elements of both FSP and traditional outsourcing. The sponsor may outsource certain functions to an FSP while retaining control over others or engaging multiple FSPs for different aspects of the trial. This model offers flexibility and the ability to tailor the outsourcing strategy to the sponsor’s specific needs.²
Component-Based FSP Model: In this model, the sponsor outsources specific clinical trial functions, such as data management, monitoring, or pharmacovigilance, to specialized FSPs. This approach allows the sponsor to access deep expertise in each functional area while maintaining overall control of the study.
Tech-Enabled FSP Model: This model combines advanced clinical development solutions with a customized client approach. It offers access to skilled staff, cutting-edge technology, and infrastructure, enabling sponsors to optimize their clinical trials and achieve their objectives efficiently.
Talent Augmentation FSP Model: This model focuses on providing expert professionals for projects or long-term engagements, offering full clinical development support and access to a vast pool of qualified talent in various functional areas.
Managed Workforce FSP Model: In this model, the FSP provider offers purpose-fit clinical development support, unique staffing plans, and access to skilled staff, along with complete recruitment and performance management services.

Maxis Clinical Sciences offers a range of FSP models that align with these industry-standard approaches. For example, MaxisFlex is a Hybrid FSP model, MaxisAdvance is a Tech-Enabled FSP model, MaxisTotal is a Fully Outsourced FSP model, MaxisAgile is a Talent Augmentation FSP model, and MaxisSync is a Managed Workforce FSP model. By providing these options, Maxis Clinical Sciences ensures that sponsors can select the approach that best suits their specific requirements and enables them to efficiently run their clinical trials.

Why implement FSP Models?

The appeal of FSP models continues to grow, with market utilization expanding steadily from 28% in 2018 to more than 40% in 2021. Recent data indicates that this growth trend is persisting¹. There are several compelling reasons why sponsors should consider implementing an FSP model:

Cost Efficiency and Flexibility: FSP models enable organizations to outsource the functional aspects of the job while retaining control of the job and data. This facilitates cost and efficiency gains, as well as the ability to be agile and have more control over data. FSPs offer the flexibility to adjust resources as needed throughout the trial, ensuring optimal utilization, and avoiding the costs associated with maintaining a large, fixed in-house team.
Access to Specialized Expertise: FSPs bring deep knowledge and experience in their respective functional areas, allowing sponsors to tap into a pool of talent that may not be available in-house. This expertise helps sponsors navigate the complexities of clinical trials and ensures high standards of quality and compliance.
Ability to Fill Any Service Gap: FSPs can provide individually tailored and customized programs to meet the unique requests of clients, whether it’s a small gap in an individual team or delivering multiple functions across a portfolio of programs. This flexibility allows sponsors to address any clinical development need they may have.
Improved Site Relationships: As drug development continues to evolve, site relationships are becoming increasingly important. FSP models can help sponsors foster and maintain strong site relationships, which are crucial for successful clinical trials.
Access to Technology Innovations: FSP partnerships can help sponsors access and leverage the latest technology innovations in clinical development. By partnering with FSPs that have expertise in digital tools and platforms, sponsors can streamline processes, improve data quality, and drive better outcomes.

Best Practices for Successful FSP Implementation

Success in FSP partnerships starts with strong strategic planning. Organizations should define clear objectives and scope for their FSP engagement, backed by measurable KPIs. Well-documented SOPs and governance frameworks create a solid foundation for the partnership, allowing both sponsors and FSP partners to work efficiently toward common goals.
The operational aspect focuses on building the right team with the right expertise. This means having dedicated professionals who understand your therapeutic area, supported by streamlined knowledge transfer processes. Regular training programs and systematic documentation keep everyone aligned, while ongoing performance monitoring helps fine-tune operations for better results.
Transitioning to an FSP model often involves significant changes to processes, systems, and team dynamics. Sponsors should invest in change management initiatives to ensure a smooth transition and maintain employee engagement.
Building a strong, collaborative relationship between the sponsor and FSP teams is critical for success. This involves open communication, trust, and a shared commitment to achieving common goals.
Modern FSP partnerships thrive on smart technology use. Advanced clinical trial technologies, standardized data systems, and integrated project management tools work together to speed up processes and reduce errors. Real-time reporting gives teams instant insights into project status, helping them make faster, better-informed decisions.
Quality drives everything in FSP partnerships. From continuous monitoring and regular assessments to standardized processes across functions, every aspect is designed to maintain high standards. This data-driven approach helps sponsors achieve consistent, reliable results throughout their clinical trials.

Takeaways

There has been a move away from full-service outsourcing to more customizable solutions, with companies seeking greater ownership and control over the development of their compounds. This shift has led to the emergence of the FSP model, which can offer substantial cost savings compared to traditional full-service models – for instance, Maxis Clinical provides outsourcing services at up to 30% lower cost. One of the primary benefits of the FSP model is that it enables sponsors to regain strategic control, allowing them to collaborate closely with the vendor and make informed decisions on resource allocation based on the specific needs of the clinical trial. As a result, successful FSP collaborations often involve the vendor becoming a virtual extension of the sponsor company, with regular touchpoints and open communication throughout the partnership, ultimately fostering a more efficient and effective clinical trial process.

To ensure a seamless FSP collaboration, it is important to have a playbook in place that includes steering committee meetings and governance charters. Sponsors should also tailor their request for information (RFI) to the FSP model, focusing on embedded resources and portfolio-level goals rather than unit costs and isolated trials. As the clinical research landscape continues to evolve, it is likely that more sponsors will explore FSP models as a means of driving efficiency, quality, and innovation in their trials.

If you are considering an FSP model for your clinical trial, it is important to carefully evaluate your needs, select the right FSP partner, and establish clear processes for communication, governance, and performance monitoring. With the right approach, an FSP model can help you achieve your clinical trial objectives while positioning your organization for success.