The Human Connection: Sustainable Quality in FSP

FSP Clinical TrialsSustaining the quality of deliverables from FSP teams and minimizing staff turnover can be a significant challenge for Sponsors of all sizes.

The contractual agreement is key for setting the correct expectations. It must be clear and specific about the level of quality expected, including measurement metrics to show performance against those quality expectations and it must set out an appropriate governance strategy to monitor all aspects of that contract.

Knowledge workers are required for FSP teams. Generally these workers are motivated by progression in their chosen fields and consistent learning opportunities, in addition to salary benefits, of course. Staff turnover increases when vendors cannot satisfy their progression and learning desires.

This problem is compounded by the fact that FSP staff tend to operate in a “silo”, separate from their co-workers running traditional projects. They may be excluded from company meetings and may not receive generic training or take part in team building.

The silo approach causes another problem. One of the benefits of working with staff in a Contract Research Organization is access to best practice and innovation. These assets are gained by staff when working with a number of customers. Once a vendor moves the FSP into a silo, these benefits are reduced and eventually disappear.

CROS NT has evolved the FSP model to introduce “Next Generation FSP” – or FSP 2.0 – a model that retains the advantages needed by Sponsors but deals with the human elements that impact sustainable quality.

Under the FSP 2.0 model, the FSP Manager and principal staff are dedicated to the project and there is rarely turnover at these levels as the roles are more demanding and thus satisfying the progression and learning elements and allowing a senior core to build, develop and retain the knowledge base.

For the majority of the team, the model is to work 60-70% on the FSP contract and during time off the contract, team members are exposed to other customers and have access to internal trainings. As CRO personnel are very used to moving between projects, this model brings advantages to the Sponsor. Individuals can grow, learn and see variety introduced into their work plans and integrate into the company more fully and develop in a more rounded fashion, which lowers staff turnover. The Sponsor benefits from a more stable team and gets the “outside perspective” into the bargain.

Functional Service Provision team

For more information on the FSP Model:

Guaranteeing Sustainable Quality in Statistical Programming via FSP
Functional Service Provision for Small & Medium Enterprises: how does it work?
5 Questions and Answers about Micro Functional Service Provision

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