March 2018
A growing trend within Clinical Operations and Development practices is “Functional Outsourcing” where a sponsor company can segment out specific functions in a “cafeteria style” format to partner vendors while focusing in house on their core competencies.
Recent articles published have highlighted the key factors to consider with this Functional Service Provider (“FSP”) model to help companies achieve the level of efficiency and flexibility of outsourcing without compromising quality.
Major factors to consider when selecting an FSP partner:
Cultural Fit Start the vetting process for an FSP relationship by asking about company values, how conflicts are resolved, communication channels, management oversight, and approach to customer service. Answers to these questions should be in alignment with your approach to clinical research and collaboration.
Experience Obviously, if you are pursuing an FSP relationship, you want a partner 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 vendors also will have recommendations for training programs, which will ensure a seamless integration between vendor 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.
Consistency Sponsors should ask potential 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 on-boarding. These strategies should be part of the foundation of the FSP partnership.
Flexibility and Scalability Sponsors should ask vendors how they plan for and handle the need to scale up quickly, as well as how they avoid under-utilizing 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 vendor 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 potential partners 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.