The Benefits of Actalent’s FSP Model for Clinical Development Services

Actalent Clinical Development Services Expert Christina Papanagopoulous

Understand FSP vs FSO benefits and explore how the Actalent FSP model helps pharma and biotech streamline clinical trials with expert, scalable managed services.

Clinical trials are where lifesaving science meets operational complexity — they are multifaceted, lengthy and resource-intensive. Success often depends on selecting the right solutions, partners and models. Pharmaceutical and biotech organizations conducting trials have several options to support these intricate projects. Among them, one model stands out for its versatility and effectiveness: Functional Service Providers (FSPs).

Available Models: In-House, FSO, FSP

Clinical trial sponsors typically evaluate three primary models that offer different advantages in control, flexibility and scalability.

In-House Resources

At one end of the spectrum, some companies rely heavily on internal resources to conduct clinical trials. This in-house model offers strong oversight and control, but often at the cost of flexibility and scalability. Building and maintaining an essential infrastructure — such as CTMS systems, SOPs and quality frameworks — requires significant time and investment. Additionally, in-house models must be able to rapidly deploy and manage specialized talent across a wide range of expertise. Failing to do so efficiently can significantly delay progress toward critical trial milestones.

Full-Service Outsourcing

At the other end of the spectrum are organizations that rely on full-service outsourcing (FSO) models to manage the entire scope of clinical trial projects. This includes oversight of clinical trial execution, staffing, regulatory compliance and vendor management. FSOs are often the preferred choice for companies lacking the internal infrastructure or bandwidth to manage trials independently. However, this model can be costly, less flexible and challenging to control, often resulting in limited visibility into day-to-day operations.

Functional Service Provider

Fortunately, there’s a model that blends the strengths of full-service outsourcing with the control, visibility and flexibility of in-house operations. Functional service providers offer a balanced approach, delivering specialized talent and operational excellence while allowing organizations to retain oversight and agility.

Partnering with Actalent on a tailored FSP solution empowers pharmaceutical and biotech teams to scale efficiently, optimize clinical development and meet critical milestones without overextending internal resources.

Types of FSP Models

Instead of fully outsourcing all management and operational responsibilities to a full-service organization, Actalent’s FSP model gives you the flexibility to choose which project tasks to remain in-house and which are delegated to an external partner. This selective approach allows for greater control, visibility and alignment with your internal capabilities.

There are three main types of FSP models, each defined by the level of complexity and responsibility transferred to the partner:

Project-Based FSP: Ideal for trials with clearly defined milestones, timelines and deliverables. In this model, Actalent delivers tailored staffing solutions to meet your specific requirements, while your internal team retains responsibility for managing daily operations. Actalent ensures that deliverables are met and milestones are achieved on schedule.

Hybrid: Also known as a “blended” or “unitized” model, this approach is best suited for completing defined assignments or specific aspects of a larger trial within a set timeframe. Actalent provides the resources and handles line management responsibilities, while you maintain direct oversight of day-to-day operational tasks, giving you the support you need without sacrificing control.

Outsourced: For organizations requiring more comprehensive support, Actalent builds and manages dedicated functional teams of experts to support every stage of the clinical trial process, from clinical development through regulatory submission and post-marketing activities. Actalent provides regular updates and is fully accountable for delivering the agreed-upon outcomes.

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The Benefits of a Functional Service Provider

There are no defined limits between one type of FSP model and the next. The value of Actalent’s FSP model lies in its adaptability. The levels of complexity and control can be tailored to your needs as the demands of your clinical trial evolve.

Flexibility

For life sciences organizations, flexibility is critical as clinical trial needs can shift dramatically at any stage. Unlike an in-house or FSO model that may tie up resources until they are needed, Actalent’s FSP model can swiftly be scaled up or down to deploy resources based on how, where and when they are needed. You choose which parts of your trial to keep in-house while Actalent supplements your areas of expertise and experts with ours.

Control

The level of control you maintain throughout the course of a clinical trial has an impact on the quality of the data and insights you receive. Relying entirely on an FSO model can lead to trials that deviate from your intended direction, potentially resulting in skewed or even unusable data. In contrast, retaining greater control over day-to-day operations often leads to more reliable outcomes.

With Actalent’s FSP model, you can delegate the aspects of a project where your organization may lack capacity, experience or specialized expertise, while still maintaining firm oversight of the study and its results. This approach gives clear visibility into the trial’s progress, enabling you to identify and address issues proactively to avoid costly problems that put the project at risk.

Expertise

Clinical trials require a great deal of niche experience, which can be difficult to source and retain in-house. Additionally, the type of expertise needed can change, evolve or end quickly throughout the lifespan of the trial. Maintaining such a diverse team of full-time experts over the long term is neither practical nor cost-effective for most companies.

Actalent combines deep expertise in pharmaceutical and biotech disciplines with rapid access to a wide network of clinical specialists. This flexible model allows you to engage highly specialized talent only when needed, helping you avoid the cost of underutilized full-time staff during slower trial phases.

Working with Actalent as your FSP partner ensures you not only gain access to specialized talent on demand but also retain full visibility and authority throughout the trial process. This empowers you with the flexibility, control and expertise needed to navigate complexity with confidence.

Finding the Right FSP Partner for Your Clinical Trial

Clinical trials often span several years and represent high-stakes investments. That’s why it’s essential to choose an FSP who not only delivers results but also aligns with your long-term vision. While technical expertise and a proven ability to source niche talent are critical, a true partner goes further. They take the time to understand not just the objectives of your trial, but also your broader business strategy and goals.

Striking the right balance between strategic alignment, customization and high-quality embedded talent directly influences the cost-effectiveness and efficiency of the partnership.

Focus on Strategic Fit

Actalent’s success lies in customization. We begin every FSP engagement with an in-depth discovery discussion that helps us understand your needs, capabilities, pain points, gaps and goals of your clinical trial. We want to know the reality of where you are today, what you are ultimately looking to accomplish, and how the trial fits in with the overall strategy and vision for your organization. Together, we define a communication plan and governance structure, so you always know when to expect an update and who to contact anytime questions arise.

Focus on Talent and Integration

With a clear understanding of what you and your organization are looking to achieve, Actalent brings you candidates who have the specific functional expertise your trial demands. The team you work with at the outset will stay with you throughout the engagement, ensuring continuity and trust. We proactively work to retain the talent you’ve come to rely on, making them available for future engagements whenever possible. By embedding into your tools and processes, and even your culture, our professionals serve as seamless extensions of your team, accelerating delivery and strengthening outcomes.

Focus on Tailored Solutions

Actalent’s managed services are fully customizable to your unique needs and can flexibly integrate with your in-house capabilities or existing vendor partnerships. Our managed services span a wide range of clinical trial functions, including:

Investigator-Initiated Study (IIS) management
Project management
Clinical monitoring and site management
Study start-up support
Vendor selection and management
Data management and more

We prioritize full transparency at every stage of the process, from cost structures to talent sourcing and hiring practices and reporting cadence, ensuring you stay informed and in control throughout the partnership.

Why Choose Actalent as Your Functional Service Provider

Actalent’s FSP offerings enable life sciences organizations to scale and supplement core functions while outsourcing non-core functions. Our involvement goes beyond our ability to provide access to hard-to-find expertise for clinical research functions. By working with Actalent, you also gain a strategic partner committed to executing your vision and reducing your operational burden at every stage of trial development.

Frequently Asked Questions About FSP Models

What is an FSP?

A Functional Service Provider (FSP) is a strategic outsourcing model often used in clinical trial functions where a life science company delegates selected tasks to an external partner while the company retains overall control. This approach allows organizations to supplement internal capabilities with specialized expertise as needed.

What is FSP in clinical research?

In clinical research, FSP refers to the outsourcing of targeted operational functions such as data management, clinical monitoring or regulatory affairs to a specialized partner. This model offers scalability, expert resourcing and process efficiency while allowing the sponsor organization to retain control over clinical trial execution.

What is an FSP vs. FSO?

A Functional Service Provider (FSP) provides support for selected functions of a clinical trial, enabling the trial sponsor to maintain oversight and strategic direction. By contrast, a full-service outsourcing (FSO) model transfers full operational control of a study to a third-party staffing provider, which may reduce the trial sponsor’s visibility and flexibility.

What are the benefits of FSP for testing laboratories?

FSP models enable organizations to scale operations quickly, access specialized talent and reduce administrative burden throughout the lifespan of a clinical trial. This support allows for focus on core competencies, meeting project demands efficiently and maintaining compliance without overextending internal teams.

What is the ideal scale for FSP outsourcing models?

FSP outsourcing models are flexible and can be easily scaled to support small, function-specific needs or large, multi-functional operations across the full clinical trial life cycle. They’re ideal for organizations seeking agility, whether launching a new study or managing several trials concurrently.

What services are included in FSP outsourcing models?

Functional Service Provider (FSP) outsourcing models typically include a wide range of services such as Investigator-Initiated Study (IIS) management, project oversight, clinical monitoring, site management, study start-up support, vendor selection and oversight, data management, medical writing, and quality assurance. Actalent tailors these services to match the unique requirements of your clinical trial and seamlessly integrate with your internal teams and capabilities.