Functional Service Provider (FSP)

The Emerging Biotech’s Guide to Creating Scalable Infrastructure With a Functional Service Provider

For a biotech company, sudden growth can come in many forms. When your company finds it necessary to scale quickly while still maintaining complete oversight over every aspect of your study, partnering with a functional service provider (FSP) may be an excellent solution.

Complete control over your projects and data

Under an FSP model, you gain access to a dedicated corps of experts that works alongside your study teams to deliver long-term support for key functions and meet project-specific needs. This allows you to leverage existing infrastructure and expertise in a way that is both flexible and scalable, with none of the constraints and capital investment triggered by hiring full-time staff.

While full-service solutions also offer the benefit of experienced personnel to oversee and manage the ins and outs of your study, FSP models provide you with complete control — control of the people, control of the processes, control of the data.

Of course, that same level of control is also possible if you use a staffing model — but staffing presents other shortcomings. A staffing company recruiter or manager, even those with some life sciences experience, likely won’t have the same depth of knowledge as those at a clinical research organization who are embedded in this work on a daily basis. In addition, a staffing company sees its job as filling the position; for a professional CRO FSP partner, the job has only just started once the employees are in place. A functional service provider will focus on long-term partnerships at all levels of management and consequently provide support throughout the length of the engagement.

Therapeutic expertise, agile processes, and technology with seamless integration

FSP begins with people — partners and collaborators who bring deep expertise and critical advice. However, not everyone realizes that an FSP model can include the implementation of optimized processes and technology as well. For instance, in recent engagements, Premier has supplied:

  • Gap analysis of the existing processes
  • Assistance crafting SOPs, including both document templates and standards for data collection
  • Standard metrics packages
  • Identification of the optimal technology systems for the study’s precise needs

Access to such expertise can be helpful for any company but is especially useful for a smaller company. A well-built FSP team includes a host of experts to address the study’s specific issues — experts who together can help create end-to-end solutions that ensure a study stays on track through every critical juncture.

This is because well-established functional service providers have already done the hard work of identifying the best talent in the best locations, including understanding tax structures and regulatory requirements and processes. That knowledge enables a study to hit the ground running.

Of course, growth comes in many forms. An FSP model is also a good solution for companies that want to expand geographically. At Premier, for instance, we literally have people on the ground around the globe. When a recent sponsor wanted to move into a new region, we were able to help them choose between regions including Central Europe, Eastern Europe, South Africa, and India to find the best technical and medical expertise for their needs.

FSP provides in-the-moment support when studies go off track

Sometimes companies turn to FSP to address unforeseen issues quickly. For instance, an oncology-focused sponsor in-licensed a very successful product and quickly found itself operating several large Phase 3 clinical studies concurrently. When the sponsor noticed that timelines were slipping and that data management work was being redone, they engaged Premier Research as an FSP partner to evaluate the quality of their operations.

Premier immediately assigned a program data management lead to review all of the company’s oversight SOPs. Through this process, the program data manager identified gaps in both oversight and data management processes, and we got to work. Within a month, we assembled a dedicated FSP data management team. Operating under the newly developed SOPs and with full transparency, Premier put into place new and extensive reconciliation methods to ensure accuracy, completed a monumental data cleaning, and met the original timeline.

Immediate expertise drives success, saving time and money

Providing functional expertise is what functional service providers do — the specialized knowledge to drive your business and the manpower to translate plans into action. No wonder FSP engagements often become long-term relationships. At Premier Research, our longest FSP engagement has been ongoing for 24 years; a third of the staff on that project has been supporting it for ten years or longer.

FSP support can be helpful for companies with eight employees and for companies with 88,000 employees — any time additional help is needed. It may be most crucial, however, for smaller companies that lack the physical resources to capitalize on big opportunities. FSP provides the expertise and instant infrastructure to move things ahead quickly while still retaining complete control.

Since 1998, Premier Research has partnered with leading pharmaceutical, biotech, and medical device sponsors worldwide to deliver long-term support for key functions and meet project-specific needs. For more information on how we help, click here.