FSP vs. Full Outsourcing: Today’s Model for Today’s Challenges

Functional service provider (FSP) partnerships have gained popularity in recent years because of their potential to increase efficiency and flexibility in outsourcing without compromising quality. Well-defined services within the scope of a clinical trial project or program, such as Biostatistics, SAS Programming, and Data Management, are good candidates for FSP outsourcing. By outsourcing individual functional services, client companies gain freedom and are able to retain more control than they likely have in a traditional preferred provider relationship or when outsourcing an entire study.

In order to understand the difference between FSP and full-service outsourcing, the intended meaning of FSP must be clearly defined. Traditionally, clients have outsourced entire clinical trials or programs to CROs, often within the scope of a preferred provider relationship. In recent years, many clients have moved away from these kinds of relationships toward an “a la carte” outsourcing model, or FSP relationships. In this FSP model, clients pick and choose which services, or functions, to outsource based upon their specific study/programmatic needs, then contract with service providers who specialize in those functions.

There are clear advantages to using specialists but the overall partner relationship should be a priority. Many factors contribute to a successful FSP relationship, and when evaluating companies as potential FSP partners, clients should look for certain qualities. When shopping for an FSP partner, the following factors should be considered:

  • Cultural Fit
  • Experience
  • Consistency
  • Flexibility
  • Scalability

These characteristics are important when seeking to establish an FSP relationship that has the potential to reduce time and costs without compromising data integrity or quality of work . There are many companies in the industry that provide FSP services and at varying scales, it is key to conduct a thorough evaluation to identify an FSP partner that is the best fit for your project or program.

While the FSP model is collaborative in nature and is put in place to achieve the same goals as the full outsourcing model, it does not involve the use of provider systems in place of client systems, and no assets change hands. The true definition of an FSP is to outsource an entire function to a provider across all studies and therapeutic areas. The FSP would utilize the client systems, SOPs, and processes with the client retaining overall responsibility for the deliverables. Most clients are already investing heavily in their own systems and infrastructure and would be wise to avoid duplicating that investment by also paying for a partner to provide its proprietary technology.

The attraction of the FSP model lies in the flexibility it offers to become a unique solution to each client. It is a scalable model allowing clients to adequately resource their departments 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.

This model focuses on the economics of delivery while maintaining the standardization and consistency necessary to drive high-quality data output. If there is not a centralized decision-making mechanism within a client organization or if there is freedom for functions to operate somewhat independently from one another, then often each function has autonomy on its choice of supplier. Therefore, the more a client chooses to select and manage a vendor across independent functions, the more likely they will gain efficiencies from going the FSP route. Another benefit of this model is it enables the delivery of best-in-class resources by function. If a client solely uses a full-service CRO, they risk receiving inadequate support – “the B/C team” – rather than a top-notch team curated specifically for their functional need.

It is becoming apparent in the industry that FSP outsourcing can deliver cost savings in terms of operational efficiency but also in reducing the overall program budget. Many clients are already in situations where they have gradually outsourced an increasing volume of work. As these companies have increased their outsourcing, they are forced to maintain an internal overhead associated with oversight of the work. Often, clients have been unable to reduce the amount of overhead devoted to full-service contracting. In an FSP relationship where the emphasis is on managing providers by function, clients can maximize their internal resources around project management and conduct oversight correctly.

Under the FSP model, the partner can provide the client with transparent performance metrics within the given function and the reporting of those metrics that are actionable. In addition, the FSP solution typically devotes senior-level oversight, structure, and attention to not just the relationship but the delivery across the entire portfolio.

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