Functional Service Provider (FSP)
What is a functional service provider (FSP)?
A functional service provider, or FSP, is a model where contract research organizations provide specific functional services that support clinical research activities.
The services of an FSP may include:
- Biostatistics
- Medical writing
- Clinical trial management
- Data management
- Clinical monitoring
- Pharmacovigilance
- Regulatory affairs
- Safety monitoring
- Project management
- Quality assurance and control
- Site management and support
Utilizing an FSP is an alternative to outsourcing an entire clinical trial to a single CRO, which isn’t always practical as it doesn’t allow for specialization or flexibility. In comparison, the FSP model allows companies to outsource specific functions to CROs that specialize in those areas.
What are the benefits of a functional service provider (FSP) in healthcare?
The functional service provider model has emerged as a response to the changing needs of the biotech and pharmaceutical industries; it allows a company to outsource specific tasks to CROs specialized in completing them, and it can offer numerous benefits.
First, FSPs allow for cost savings as they allow companies to outsource specific functions, not the entire trial. This allows for more flexibility in the clinical trial’s budget.
Additionally, there is greater flexibility in who completes each task. A company can choose experts for each task who offer more tailored solutions and ensure compliance with regulatory requirements.