The clinical development landscape is undergoing a significant transformation, with a marked shift from traditional Full-Service Outsourcing (FSO) models to more agile Functional Service Provider (FSP) partnerships. This evolution is driven by the increasing complexity of clinical trials, the need for specialized expertise, and the demand for greater flexibility and cost efficiency.

The Evolving Landscape: FSP vs. FSO

Recent industry analyses highlight a growing preference for FSP models over FSO. A 2024 survey revealed that 41% of biopharmaceutical companies have increased their use of FSP outsourcing, compared to 27% for FSO . This trend underscores the industry’s move towards models that offer enhanced adaptability and resource optimization.

The FSP model allows sponsors to outsource specific functions—such as clinical monitoring, data management, or biostatistics—while retaining strategic oversight. This targeted approach contrasts with the FSO model, where a single contract research organization (CRO) manages the entire clinical trial process.

The table below identifies key strategic differences between the two models.

FSOFSP
Approach

  • Full-service project/compound specific model

  • Covers all facets of clinical trial
    execution

  • FSO has control of the clinical trial


  • Integrated/embedded cross-functional

  • Pipeline-driven partnerships

  • KPS Life staff embedded in Client’s
    existing infrastructure and processes

  • Client retains strategic control
Operating Infrastructure

  • FSO provides and finances


  • Leverages Client infrastructure and SOPs
Contracts/Cost

  • Trials tied to specific protocols with defined term

  • Milestone-based/hourly

  • Potential for change orders


  • Pipeline-driven, renewable

  • Customized as either FTE or T&M

  • No change orders
Experience

  • Often lower-level experience leading to increased turnover


  • Meeting agreed upon candidate profile; typically, high industry experience resulting in a high retention rate
Branding

  • No brand benefits to Client


  • Strong brand benefit as FSP team is an extension of the Client Team
Resources

  • Resources often working with
    multiple Clients


  • KPS Life resources dedicated 100% to
    one Client

Advantages of the FSP Model:

  1. Enhanced Flexibility and Scalability
    FSP partnerships provide sponsors with the ability to scale resources up or down based on project needs, enabling more responsive and efficient trial management .
  2. Access to Specialized Expertise
    By engaging FSPs, sponsors can tap into a pool of specialized professionals with deep expertise in specific functional areas, leading to improved trial quality and outcomes.
  3. Cost Efficiency
    FSP models often result in significant cost savings. For instance, KPS Life’s FSP approach has demonstrated an average of 30% reduction in study costs through efficient resource allocation and management.
  4. Improved Operational Control
    Sponsors maintain greater control over trial operations, as FSPs integrate into the sponsor’s existing infrastructure and processes, ensuring alignment with organizational standards and objectives.

KPS Life’s FSP Model: A Strategic Advantage

KPS Life’s FSP model is designed to align seamlessly with Sponsors’ operational framework, offering:

  • Dedicated Teams: Professionals embedded within the sponsor’s infrastructure, ensuring consistency and continuity.
  • Customized Solutions: Tailored approaches that meet specific project requirements and organizational goals. 
  • Efficient Resource Management: Optimized allocation and redeployment of resources to maximize productivity and cost-effectiveness.
  • Strategic Oversight: Maintaining sponsor control over critical trial aspects while benefiting from the FSP’s specialized capabilities.

KPS Life Differentiators

One of the notable differentiators of the KPS Life FSP model lies in the flexibility and customization we offer to become a unique resourcing solution to the Sponsor. It is a scalable model allowing the Sponsor to adequately resource your respective departments with direct involvement with candidate identification in line with increased or decreased support requirements in real time without the additional burden of HR processes (such as hiring and onboarding, associated with permanent headcount).

Our embedded resourcing model focuses on the economics of delivery while maintaining the standardization and consistency necessary to drive high-quality data output and efficiencies from engaging our broad spectrum of agile FSP solutions. Another demonstrated benefit of the KPS Life model is that it enables the assignment of best-in-class resources by function and delivers a fully dedicated team curated specifically for your stated functional needs. As we shared, KPS Life maintains a +90% retention rate of our team assuring continuity and consistency of delivery on a given project. This not only provides ‘peace of mind’ but affords the Sponsor greater span of control and the acceleration of development timelines at dramatically lower costs.

Governance: KPS Life Concierge Approach

At KPS Life we understand the importance of governing our relationship with the Sponsor for the duration of the program. We employ a high-touch philosophy that embraces the true meaning of delivering customer satisfaction by ensuring our organization, to include the executive sponsors assigned to this project are engaged and invested in the positive outcome of your projects.

The concierge methodology we have initiated at KPS Life aims to save time, effort, and energy for the Sponsor team. The Sponsor will have total access to our executive sponsors to insure rapid de- escalation of any issues that may arise or the immediate removal of any barriers to success on the protocols. KPS Life is committed to meet your needs and expectations of this project.