FSP

Micro-FSP

FSP – Functional Service Provision is a popular outsourcing model for clinical trial Sponsors and was originally developed by larger pharmaceutical companies to achieve significant cost reductions across a program of studies with a goal of increasing quality.

This solution is not suitable for all companies due to a smaller scale project, budget restrictions or just not having enough workload in the pipeline to maintain full-time resources. For example, small medium enterprises (SMEs) will not need a team of a hundred statistical programmers or data managers but may require a smaller team for a limited time.

At CROS NT, we have worked over the years with our clients to develop a solution that would better suit smaller teams and will help the sponsors with the challenges faced during drug development such as rising costs, fluctuations in workload, staff augmentation needs and finding expert resources. We have created a Micro-FSP solution to meet the needs of resourcing small teams for specific periods of time.

What is the Micro-FSP Solution?

The Micro-FSP solution 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 start-up. 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 of both.

Who is the Micro-FSP Solution suitable for?

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 for a specified period.

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:

  • Biostatistics
  • Statistical Programming
  • Clinical Data Management
  • Medical Writing
  • Pharmacovigilance Resources (data entry, case processing, etc)
  • Monitoring
  • Expert Statistical Support

What are the benefits of Micro-FSP vs traditional outsourcing?

  • Stable pricing model – the Micro-FSP model ensures stable, yet flexible for small to mid-size companies. Pricing models can be delivery based or FTE pools where usually a short notice period to switch on and off resources.
  • Waste reduction – a Micro-FSP allows you to pay for the resources that you need and not commit to full-time resources. Contracts can be extended quickly if you pipeline changes.
  • Flexibility – key for a Micro-FSP and this solution provides mroe adaptive approach to resources. You choose when you need the resources and for how long. We will do the rest.
  • Exceptional teams – at CROS NT, we have access to some of the best resources of the industry. We have a proved track record of supporting companies by integrating seamlessly into their existing teams and applying knowledge learned through the years.
  • Capabilities increase – ulilising expert resources from CROS NT, you can take on workload that would otherwise have to be rejected due to not having the in-house capabilities. Our teams can support you with many areas, including Statistical Consultation, CDISC, Data Mapping & Visualisation, ISS/ISE, Medical Writing, Pharmacovigilance and Data Management

Would you like to learn how our Micro-FSP model can help you to create the right team for your clinical trial? Send us a request by filling in the contact form.