By Dawn Edgerton, assistant VP of operations, Rho
Functional service provider (FSP) partnerships have been gaining traction 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 (e.g. data management, biostatistics, or medical writing) are good candidates for FSP outsourcing. By outsourcing individual functional services, sponsor companies gain freedom they might not have in a traditional preferred provider relationship or when outsourcing an entire study. However, many factors contribute to a successful FSP relationship, and when evaluating CROs as potential FSP partners, sponsors should look for certain qualities.
First, you must understand the difference between FSP and full-service outsourcing. Traditionally, sponsors have outsourced full-service responsibilities to CROs for their clinical trials, often within the scope of a preferred provider relationship. Recently, some sponsors have moved away from these kinds of relationships toward a “cafeteria-style” outsourcing model, or FSP relationships. In this model, you can pick and choose which services to outsource to which CRO based on the CRO’s areas of expertise.
Start the vetting process for an FSP relationship with a CRO by asking about company values, how conflicts are resolved, communication channels, management oversight, and approach to customer service. The CRO’s answers to these questions should be in alignment with your approach to clinical research and collaboration.
Obviously, if you are pursuing an FSP relationship, you want a CRO that has experience with this type of model. That way, it’s likely it has worked out the kinks and will be able to hit the ground running with a new sponsor. Experienced CROs also will have recommendations for training programs, which will ensure a seamless integration between CRO and sponsor staff as well as ensure new staff members are trained quickly and efficiently. Ask if the company has suggestions for the best way to work together, including overall program management, rapid start-up processes, points of contact, system usage, process development, deliverable and timeline tracking, and billing.
Sponsors should ask potential CRO partners about company and team turnover rates. In addition, ask about the company’s strategy for maintaining and disseminating program-related knowledge across their team (e.g. therapeutic, protocol, and system knowledge) as well as how they handle team member departure/reassignment and onboarding. These strategies should be part of the foundation of the FSP partnership.
Flexibility and Scalability
Sponsors should ask the CROs how they plan for and handle the need to scale up quickly, as well as how they avoid underutilizing resources. In both cases, some sort of strategic forecasting and proactive communication should be part of the plan. Program governance meetings are an excellent strategy for managing the resourcing demands of a successful FSP partnership. These meetings can occur as often as necessary to ensure constant communication between CRO and sponsor. Both parties should contribute to the agenda to ensure active engagement and bidirectional communication. These meetings can be beneficial in maintaining a big-picture view of the FSP partnership, and they encourage direct and frequent communication between team members.
All of the previously mentioned characteristics are important when seeking to establish an FSP relationship that has the potential to reduce time and costs without compromising scientific integrity or quality. There are many CROs in the industry that provide FSP services, so it’s necessary to conduct a thorough evaluation to identify an FSP partner that is a good match for your project or program. In an industry where the goal is to get approvable drugs to market as quickly as possible, consistency in all of these areas is a winning formula for identifying an FSP partner that sponsors can trust.