Custom FSP Models That Help Biotechs Scale Smarter

Drug development is changing. Biotechs and mid-sized biopharma companies can no longer rely on traditional development approaches when racing against time and budget constraints. Early-stage failures, complex regulations, and the constant need for specialized expertise have pushed the industry to reimagine how drug development work gets done. This evolution has sparked new outsourcing models in life science research, fundamentally changing how companies access and deploy critical resources.

The role of Functional Service Providers in the future of drug development

Sponsors are now embracing innovative engagement models tailored specifically to their needs. The shift from “buying” to “building together” is empowering sponsors remain competitive and fully harness the potential of their research partners. Modern biotech partnerships are more strategic, focused on combining global reach with local expertise, data-driven decision making, and sharing both the risks and rewards of innovation.

In this ISR report on clinical development outsourcing strategies, 61% of the users highlight “increased resource flexibility” as a benefit of the “Internal + FSP” model, indicating that combining internal resources with Functional Service Provider (FSP) support offers a tailored approach to clinical development. Conversely, 58% of users of the “Fully Outsourced to Multiple Providers” approach often face challenges like high training demands, longer onboarding time and a lack of integration, requiring more oversight to ensure team synergy.

This need is driving more sponsors to rely on FSP partners for their outsourcing needs. Adopting FSP offers flexibility, expertise, and efficiencies, whether you require project-specific expertise or large-scale program support with dedicated capacity management across various functions. This approach provides a competitive edge, helping you navigate the complexities of drug development with confidence.

Choosing the right FSP model for your needs

Unlike traditional outsourcing, FSP engagements are dynamic models—what works today may not be effective in the future. FSP models must align with your strategic goals, address unmet needs such as expertise, local presence, and regulatory know-how. Furthermore, technology-augmented FSP teams can be game changers, enabling innovation and building for the long term. There are two primary types of FSP models:

Staff Augmentation" An FTE-based model focused on enhancing internal capacity or adding specialized staff to fill expertise gaps. This model can typically range from individual allocations to comprehensive team augmentation.    

Strategically aligned FSP Teams

Single or multi-functional FSP teams aligned with development and efficiency goals. Backed by a robust governance structure, this model enables collaborative planning and oversight at operational, functional and executive levels.

Key criteria for FSP partner selection

When selecting a partner for FSP, it is crucial to ensure they support your needs for capacity, scale, geographical coverage, and expertise. When selecting an FSP partner, several key capabilities are essential for success. The partner should provide expert functional teams tailored to specific program needs and offer comprehensive geographical coverage that supports operations across multiple time zones, enabling smooth handoffs and continuous workflow.

Scalability is crucial, with the ability to rapidly expand operations while maintaining effective team onboarding and high retention rates for workforce stability. Strong executive oversight is necessary to maintain quality standards and foster a culture of shared innovation and continuous improvement. The partner should also possess robust IT infrastructure and technology solutions to enhance operational efficiencies, along with specialized expertise in critical areas such as PK/PD, ISS/ISE submissions, and specific therapeutic domains.

Importance of Multi-level Governance and Oversight in FSP partnerships

The optimal time to initiate governance in FSP engagements is right at the outset. This is when the program delivery structure, systems integration, ramp-up strategy, training plans, key performance indicators (KPIs), and/or service level agreements (SLAs) for project-level tasks and commercial goals should be clearly defined and agreed. Establishing these elements upfront lays a solid foundation for the partnership

As the program progresses and the partnership scales, the focus of oversight expands to include effective portfolio planning, strategic resourcing, staff retention, quality assurance and continuous improvement. Multi-level governance is instituted across functional, operational, and executive levels to ensure oversight is comprehensive. This proactive approach ensures that initial goals are maintained while adapting to emerging needs, ultimately fostering a shared vision of success.

Creating a performance-driven ecosystem

While metrics monitor progress, clear and transparent communication of these metrics empowers FSP teams to consistently work towards meeting program goals.

• Functional metrics: Typically focused on quality, turnaround time, program expertise needs and performance, with the goal to ensure all FSP resources are meeting the required standards.
• Operational and commercial metrics: Focuses on overall program and commercial health, training compliance, ramp-up, onboarding and retention.

Elements of sustainable FSP partnerships

How Precision scales clinical success with custom FSP solutions

Precision’s FSP solutions are crafted for scalability, adaptability, and operational excellence. Whether you need staff augmentation or strategically aligned functional teams, our models fit seamlessly into your operations. Leveraging either your systems and SOPs or ours, we ensure you have the access to the right expertise exactly when you and where you need them. Supported by our strong governance and oversight practices, we enable you to handle the complexities of your clinical research demands, empowering you to advance with confidence.

Explore a partnership with Precision for your next clinical program.