During our recent webinar, we brought together key industry leaders to discuss the evolution and strategic value of Functional Service Provider (FSP) models in clinical trials. The panel included Natalie Fforde, Senior Vice President of Global Strategic Partnerships at Phastar; Francis Kendall, Head of Statistical Programming, Digital and Data Sciences at Biogen; Elisa Mansfield, Vice President of FSP Operations at Phastar; and Gill Slater, Chair of PCMG and Head of Clinical Partnership Management at Leo Pharma. This report summarizes the main points and takeaways from the session.
Evolution of FSP Models
The panel discussed how FSP models have evolved from staff augmentation to strategic team-based models. The flexibility and scalability these models offer was highlighted, as they allow sponsors to access global talent efficiently while adapting to regulatory and economic pressures.
Strategic Benefits of FSP Models
The discussion underscored several key benefits of FSP models:
- Flexibility and Control: Sponsors maintain control by using their own systems and processes, to ensure alignment with internal protocols.
- Enhanced Metrics and Industry Knowledge: FSP providers offer detailed progress metrics and industry-wide insights, which can help optimize clinical trial execution.
Francis highlighted these points and said ‘’I feel that adopting these models, you have that flexible resource that you can control. With an FSP, they’ll use your systems and processes. Also, you’ve got the metrics. We find that a lot of the CRO’s who provide FSP service really give you that extra bit of metrics progress… the knowledge from the overall industry in there.’’
- Adaptability to Local Labor Laws: The importance of understanding local labor laws was emphasized, to implement effective FSP models across different geographies.
Gill emphasized this by saying that ‘’I think in terms of clinical monitoring, obviously when you’re looking at working in a global capacity, you do have to really consider what the local labor laws are. And I think from a labor perspective… you really have to think about the various different kind of operating models that are going to be able to work in different geographies.’’
Empowering FSP Vendors with Visibility
A recurring theme during the webinar was the need to empower FSP vendors with sufficient visibility regarding upcoming trial pipelines and resource requirements. For example, when working with an FSP of 100 Full-Time Equivalent (FTE) staff, turnover can be a significant challenge for many organizations, adding complexity to recruitment.
However, Phastar differentiates itself by focusing on staff retention through robust training programs and continuous investment in our team, which minimizes churn and ensures stability for our clients. Vendors must be able to anticipate hiring needs and recruit ahead of the curve. This proactive approach enables vendors to adjust staffing before changing trial demands, thereby mitigating potential understaffing risks.
Key insights provided by the panel included the importance of:
- Transparency and open communication between sponsors and FSP vendors are critical to ensure proper planning and resource allocation.
- Collaboration between the sponsor team and the FSP is crucial in refining job descriptions, particularly to match the specific project requirements. This collaborative effort ensures that new hires are culturally and technically aligned with the client’s needs.
Ensuring a Collaborative Recruitment Process
An effective recruitment strategy and specialist team of talent acquisition (TA) experts is at the core of a successful FSP model. The collaborative nature of the recruitment process—where the TA team works closely with the sponsor team—was emphasized as vital for refining job descriptions and defining role expectations. Without a clear understanding of the project’s requirements, the recruitment process can lead to mismatched hires.
Moreover, when recruiting new personnel for a new FSP relationship, ensuring they meet the necessary technical and cultural fit is a key consideration. The TA and operational teams need to vet candidates thoroughly through interviews, technical screening, and alignment with the sponsor’s culture.
Elisa discussed the challenge of scaling the talent pool to meet fluctuating sponsor demands, pointing out that understanding specialized technical and system requirements is key. She explained that a proactive approach—such as pre-vetting candidates and offering upskilling programs—allows FSP vendors to effectively build and adapt teams for growing needs. The ongoing collaboration between sponsors and FSP vendors is crucial for refining job requirements and ensuring that teams are prepared for future challenges.
Looking Ahead: The Future of FSP Models and Blended Models
The discussion concluded with an exploration of the future of FSP and full-service outsourcing (FSO) models, particularly in response to technological advancements and the growing complexity of clinical trials. While some panelists favored FSP models for their cost-effectiveness and flexibility, others questioned whether a more integrated approach—combining FSP and FSO services—might offer greater value to sponsors in the coming years.
As the clinical trial landscape evolves, the role of FSPs will continue to expand, driven by the increasing need for specialized expertise, advanced technology solutions, and scalable talent pools that can adapt to dynamic project requirements.
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