Pharma Outsourcing Simplified: Selecting the Right FSP Model

Understanding the various Functional Service Provision (FSP) models in the pharmaceutical field is key, whether you're a professional or new to clinical research. Let's break down these models into simpler terms and help you figure out which one best fits your project's requirements.

1. Understanding FSP Models:

FSP is about outsourcing certain tasks in clinical trials. Think of it as hiring an external team (like a contractor) to handle specific functions, from data management to patient recruitment.

There are four main FSP models:

• Uncapped Time & Materials (T&M): Imagine hiring a painter and paying them by the hour, regardless of how long it takes to paint your house. It's flexible but can get expensive if not managed well.
• Capped T&M: This is similar, but you set a maximum budget. It's like telling the painter they can only work up to a certain number of hours.
• Fixed Fee: Here, you agree on a total price for the entire project upfront. It's like buying a pre-packaged holiday - the price is set, regardless of individual costs.
• Ring-Fenced FTEs: You pay for a team's full-time, whether you use them fully or not. Think of it like having a personal chef on retainer, ready whenever you need them, but you pay regardless of how many meals they cook.

2. Choosing the Right Model:

The choice depends on your project's needs. Here are some factors to consider:

• Project Complexity: More complex trials might benefit from the flexibility of T&M models.
• Budget Constraints: Fixed-fee models are great for strict budgets.
• Resource Availability: If you need a dedicated team, consider Ring-Fenced FTEs.

3. References

1. The Rise of FSP Outsourcing in Drug Development" from Applied Clinical Trials Online, please click (https://www.appliedclinicaltrialsonline.com/view/the-rise-of-fsp-outsourcing-in-drug-development).

2. The FSP: Functional Service Provider in Pharmaceutical Research" by Criterium, you can read the full article (https://www.criteriuminc.com/the-fsp-functional-service-provider-in-pharmaceutical-research).