Clinical research outsourcing can be a challenging endeavor.
Selecting the right model and partners, preparing contracts, and conducting oversight can all present difficulties.
In this article you will learn about:
However, one model that has proven to be beneficial, particularly in uncertain times, is the Functional Service Provider (FSP) model.
FSP offers a range of advantages that can enhance the efficiency and success of clinical trials.
In this article, we will explore the key benefits of using an FSP in clinical trials and how it can positively impact the drug development process.
One of the primary advantages of using an FSP model in clinical trials is the financial simplicity and control it offers.
Unlike other models, the FSP strategy provides a clear and predictable costing structure, reducing the risk of change orders.
The costing is agreed upon upfront and is based on time (number of hours), rather than specific tasks or units.
This means that even if tasks need to shift or reprioritize, the costs remain the same.
Accruals and forecasting are streamlined, resulting in minimal changes from month to month.
This financial stability allows sponsors to effectively manage their budgets and avoid unexpected expenses.
Additionally, the FSP model reduces the administrative burden associated with financial management, enabling sponsors to focus on other critical aspects of the trial.
Another significant advantage of the FSP model is the simplicity it brings to resourcing.
FSP providers work closely with sponsors to find the best fit for their specific needs.
By partnering with the FSP provider and clearly communicating their requirements, sponsors can ensure they have a team that is tailored to their unique needs.
This personalized approach to resourcing not only enhances efficiency but also fosters a collaborative and productive working environment.
Additionally, the FSP model offers cost savings through resource forecasting, allocation, and redeployment.
FSP vendors leverage their existing talent pool, allowing for the quick and efficient deployment of resources.
Reduction in Operational Burden
The FSP model excels in reducing the operational burden on sponsors.
FSP providers assume responsibility for various aspects of the study, including training and onboarding, performance management, staff oversight, and administrative tasks.
By offloading these responsibilities to the FSP, clinical trial sponsors can focus on strategic decision-making and core activities.
This streamlined approach allows for increased flexibility and scalability, enabling sponsors to efficiently adjust resource demands as needed.
Whether there is a need to ramp up or decrease resources, the FSP model provides the necessary flexibility to adapt to changing circumstances.
Moreover, the FSP model eliminates term limits for contractors, ensuring the retention of high-performing individuals with in-depth knowledge of the project.
Immediate Access to Expert Knowledge
One of the most notable advantages of the FSP contracting model is that it allows immediate access to experts in specific areas of clinical trials.
For example, a small biotech can quickly hire a senior statistical programmer or an experienced clinical research associate (CRA) without the need of training them.
This allows you to have highly qualified professionals who are ready to work at a moment’s notice without delays or the need for expensive training.
The Functional Service Provider (FSP) model offers numerous advantages in clinical trials, particularly in uncertain times.
Financial control, resourcing simplicity, a reduction in operational burden, and immediate access to expert knowledge are key benefits of using the FSP model.
By leveraging these advantages, sponsors can streamline their operations, reduce costs, improve efficiency, and ultimately accelerate the development of new therapies.
The FSP model represents a strategic approach to clinical research outsourcing that can drive success and innovation in the drug development process.