by Natalie Fforde, Senior Director of FSP Services at Cytel
With effective use of outsourcing, sponsors are able to respond to market needs and change course where necessary, while ensuring a pool of highly qualified personnel are available to work on clinical trial projects. At Cytel we work with our clients to tailor the outsourcing model that works best for an organization's particular circumstances.
In this blog, I will take a look the Functional Service Provider ( FSP) outsourcing model and some of the key factors that can help make a partnership ‘tick’ successfully.
There needs to be extensive planning at the outset to agree not only the high level aspects of the partnership, but also dig into the detail of exactly how the CRO team will be brought on board- from training through to access to laptops. This planning should include a comprehensive kick off meeting that hands over to the CRO exactly what the sponsor is looking for from the partnership.
Communication and Cultural Fit
An FSP model tends to be a longer term partnership and so time and effort needs to be invested to establish the strong communication, trust, and mutual objectives that are critical to success. The CRO Engagement Director has a key role to play in overseeing the overall health of the partnership and managing day to day tasks such as resource utilization and performance evaluations. For smooth communication it’s often helpful for the functional leads within the sponsor and CRO organizations to be located closely in physical terms, as well as have good cultural fit.
Training, Knowledge Development and Retention
A clear training and onboarding plan that gets the CRO staff up to speed on the sponsor’s SOPs and systems is fundamental to the partnership set up. Training and development should also be an ongoing initiative and is a key factor in ensuring retention. As part of your evaluation of an FSP vendor, it is important to discuss the measures which have been taken with regard to training and process improvement. Remember that access to interesting, meaningful work is a key factor in retaining technical staff so ensuring that the CRO FTEs are assigned to appropriate roles is important.
As part of the governance of an FSP clear communication pathways should be established between the various stakeholders from both the sponsor and CRO. An FSP governance structure typically incorporates a governance committee, communication plans, and Key Performance Indicators (KPIs) established collaboratively to ensure that the partnership is kept on track.
Resourcing/ Ramp Up Capability
The ability to resource and retain talent is one of the most important success factors for FSP delivery. Access to an in-house recruitment team with a strong background in biometrics and the tenacity to source talent in a highly competitive market is a key predictor of ramp up success. As part of a bid defense it is wise for sponsors to actually meet the recruiting team who will be responsible for finding the staff for the FSP.
To learn more about the drivers and outcomes of FSP partnerships click the button below to download the white paper Ensuring Data Quality Through a Specialized Functional Service Provider Model authored by Cytel Senior VP Clinical Research Services, Jim Baker.
About the Author
Natalie Fforde is a Senior Director in FSP services at Cytel. Her role encompasses a variety of responsibilities including managing ramp up, resourcing and engagement for Cytel's FSP customers. Natalie has worked in resourcing, sales management, and operations in the pharmaceutical biometrics sector since 2002.