5 Questions and Answers about Micro Functional Service Provision

Functional Service Provision Clinical TrialsFunctional Service Provision is still a popular outsourcing model for clinical trial Sponsors. While FSP has been around a long time, several variations have emerged over the years to meet the ongoing challenges Sponsors face in drug development, including rising costs, fluctuations in workload and staff augmentation needs and finding expert resources.

CROS NT has developed a “micro” FSP model to meet the challenges of resourcing small teams for specific periods of time.

What is the Micro FSP Model?

Micro FSP is a more scalable and flexible FSP model that provides expert resourcing solutions while avoiding the risk of not having enough work, or too much work, for  full time employees. The model is scalable to the specific needs of the company by providing resources for the number of days per week needed.

In order to limit the burden of a complicated transition process, the CRO’s processes and SOPs can be implemented to streamline training and startup. The location of the resources can also be flexible – either on-site at the Sponsor’s offices, remaining in the CRO’s office or a combination.

For whom is the Micro FSP model designed?

The Micro FSP is an ideal solution for small to mid-size pharmaceutical, biotechnology and medical device companies who may simply need a single resource or a small team of resources. The FSP model was originally developed by larger pharmaceutical companies to achieve significant cost reductions across a program of studies with a goal of increasing quality.

Small Medium Enterprises (SMEs) won’t need a team of a hundred statistical programmers or data managers, but a micro FSP approach can be more practical than hiring more full time staff or setting up an internal department in the first place for biometrics or monitoring functions.

What roles can be outsourced via the Micro FSP model?

Sponsors should outsource activities in which they do not have in-house expertise and the costs of hiring and setting up that internal department would be burdensome. Companies should also look at activities with significant fluctuations in workload where a scalable and flexible resourcing solution would be beneficial. These functions include:

  • Statistical analysis and reporting
  • SAS programming
  • Clinical database programming
  • Data Management
  • Medical Writing
  • Safety case data entry and processing
  • Monitoring

What are the benefits of Micro FSP vs traditional outsourcing?

Micro FSP promises sustainable quality through the deployment of expert biometrics resources and services. Operationally, this model guarantees excellent project management of resources and deliverables through well-defined KPIs. More importantly, the CRO is responsible for managing a smooth transition, the delivery of training and the continuity of the resources.

In terms of resourcing, the Micro FSP solution puts the responsibility on the CRO to cover sick leave, holidays and unexpected absences. The CROS NT model also includes a human resources and cultural element to ensure resources are a good fit in the Sponsor’s work environment.

Lastly, communication is a key element in the micro FSP process. This model guarantees consistent communication between the project manager and the Sponsor’s team to ensure efficient project kick-off and that the project is always on track according to specific KPIs and SOPs/processes.

What are the cost advantages of Micro FSP?

The Micro FSP model ensures stable, yet flexible, pricing models for small to mid-size companies. Pricing models can be delivery-based or FTE pools where usually a short notice period is needed to switch on or off resources. The Sponsor also takes on lower overhead costs as the CRO manages most of the HR and administrative costs related to resourcing, along with the training of additional resource on SOPs and processes.