What is an Functional Service Provider or FSP?
Traditionally, functions such as monitoring would be retained in house with permanent staff within a bio-pharmaceutical organisation.
Alternatively, an organisation may choose to outsource entire clinical studies (full service CRO).
The FSP model allows separation of core/non-core capabilities within your company it allows you to choose providers specialising in a discipline e.g. clinical monitoring or Biostatistics.
Clinical Professionals’ FSP model (CP FSP) additionally allows you to retain control in house of the monitoring function.
This removes the burden of employment and often reduces day-to-day management requirements but has the benefits of strategic control and direct integration within functions of your business.
Why use FSP
Firstly, FSP models have evolved to become accepted as industry best practice and have been proven to work within multiple bio-pharmaceutical organisations.
Companies are realising the need to get back to the basics of drug development.
Using an FSP for managing specific functions will help towards this.
Additionally the FSP offers benefits such as increased productivity, flexibility of workforce and cost saving. There is also an ability to work real-time, a distinct advantage over traditional CRO full service.
Two examples are :-
1. Scalability of workforce
FSPs have the ability to share workloads across monitors and FTE demand on a real-time basis, whereas CROs rigid structures and change-over procedures do not lend themselves to this.
The FSP’s increased flexibility allows the quick movement of resources across therapeutic areas, sites and/or from one study to another depending on the operating model and strategy of the sponsor company.
Most Sponsor companies and CRO’s don’t have large recruitment teams or a simple procedure for ending contracts when they need to scale back.
Therefore the most successful FSPs have a strong internal recruitment function.
Our Clinical recruitment teams are market leaders in their own right internationally and in fact 30% of their business is supplying monitoring staff to CRO’s where their own internal teams have failed.
Our FSP model will plug directly into your clinical trial management system (CTMS) and other management systems rather than the traditional CRO model, whereby they transfer data at the conclusion of a trial.
This allows you to collaboratively review data with us in real time during a trial.
We also operate a comprehensive performance scorecard to control quality and productivity levels to ensure all the monitoring is expedited as efficiently as possible.
Critical FSP Success Factors
There are a number of indicators for critical success, such as cultural fit, proven functional expertise, relative size and capabilities of the FSP in comparison to the sponsor’s needs.
A sponsor should choose an FSP based on proven functional expertise and culture but also the size of the sponsor’s requirement should relate to the FSP’s existing client profile as this helps ensure good service levels and FSP attention.
The reason for introducing an FSP model is often driven by time and workforce efficiencies rather than by cost.
However, these efficiencies create immediate cost savings such as the workforce being of the appropriate strength versus the workload required.
This avoids the scenario where staff are ‘between’ projects or where during busy periods the sponsor has to hire in expensive contractors.
The more significant but indirect cost saving is the time efficiencies which means it is possible to get a drug to market sooner i.e. a reduced cycle time.
It is often perceived by Study teams that an outsourced partner will create more work, in fact with a small amount of internal business process engineering you will have one point of contact to streamline the process. The Sponsor’s study teams would design the protocol and then leave the resourcing and process management to the CP FSP team who in turn can provide continuous updates and real-time data which supported by our performance scorecard creates a powerful service and partnership.
Who are CP FSP
Since 2006 CP FSP have been experts in delivering multinational FSP projects to our partners.
Our background in the pharmaceutical, clinical CRO, and medical device industries allows us to offer innovative bespoke and cost effective solutions seamlessly integrating into your management structure.
CP FSP is a hybrid between traditional CROs and staffing companies, built around the FSP model.
Our business utilises our in house clinical development, training and support and staffing services.
We have a track record of running International FSP teams of up to 50 monitoring staff supported by additional resources where appropriate.
We are not a full service CRO but instead our hybrid FSP model has the capabilities to deliver a flexible, targeted and efficient solution without the high costs associated with traditional CRO services.
With teams based in over 15 countries our expanding network is designed to meet the needs of our International clients.