As the market for outsourcing continues to grow, so too have the types of outsourcing models available to sponsors
These range from one-off contracts to preferred provider and strategic partnership agreements, and from tactical staffing arrangements to complex, strategic, full-service models. There are also ‘blended’ outsourcing models such as hybrid full service and FSP.
As a general rule, small to mid-size pharma and biotech companies tend to use full-service models, with the larger pharma companies being more likely to use mixed-mode models of FSP and full service outsourcing. Smaller companies tend to have fewer internal resources, meaning that it may be more practical for them to fully outsource individual projects and to concentrate their limited staff resources on management rather than conducting clinical trials. In contrast, larger pharma companies are more likely to have the infrastructure that supports mixed model outsourcing, including the use of an FSP model.
The FSP model does vary, but a combination of traditional contract staffing models; highly commoditised, low-cost, off-shore, single-service arrangements; and high-volume, functional outsourcing exercises have combined to create an evolving FSP sub-industry. While FSP can be difficult to define, its fundamentals are consistent. It is popular with organisations that wish to wholly or partially outsource a function (eg, data management, pharmacovigilance, clinical monitoring, or start-up), preferring to use their in-house IT infrastructure and standard operating procedure (SOP) platforms where they look for resourcing solutions that are flexible and can respond to the demands of their development portfolio.
In an environment where costs are closely monitored relative to product pipeline projections, the strategy to upscale internal headcount to drive trial delivery is not always attractive. FSP models can act as a supplement to or even a substitute for maintenance of burdensome internal headcount. They have the advantage of flexibility in resourcing and can facilitate central control and accountability through the use of standardised, usually customer, SOPs, and systems. FSP models push the overhead and accountability for staff recruitment and retention to a vendor, allowing for consolidation of contract staffing spend (moving from a lot of small recruitment agencies to a few global FSP providers). They support a model whereby the sponsor can execute their own trials using their own platforms, while minimising the associated fixed costs.
FSP and full-service models are equally viable options that can work in harmony as two parts of biopharma sourcing strategy. In effect, FSP and full-service models have become two sides of the same coin. Sponsors can pick and choose what works best for them to reduce costs and improve efficiency. They can selectively outsource functions where it makes sense to do so, projects where they wish to access specific CRO expertise, and access talent in all models to supplement their resources. They are adjusting their internal and relationship governance structures to reflect this approach, and vendor management organisations are becoming increasingly important and influential parts of the buying organisation.
Although strategic partnerships have sometimes been a sole source model using a single CRO, most pharma companies have preferred to mitigate the potential risks associated with using just one vendor by outsourcing to two or three preferred suppliers. For a sponsor, the benefits of using a single CRO to meet all their outsourcing needs should mitigate against any potential risks.
For global CROs, it is important that staff are able to move easily between the different outsourcing models in order to provide a seamless service to the sponsor. CRO staff should be as familiar with operating in large-scale FSP as in project-sourced models. CRO support functions, such as IT, HR and finance, have to be adaptable to the particular needs and features of the different models. Global CROs need to have substantial experience in operating governance structures with their customers that balance the demands of a research portfolio with those of the different functions and projects.
For a sponsor therefore, a CRO that is able to offer a full range of models is an attractive option as a single-source provider as it can enable an outsourcing manager to adapt any chosen model as required throughout the clinical development process.
All CROs are focused on providing optimal solutions for their sponsors. However, there are only a small number of global CROs that have the capability, infrastructure and experience to provide enterprise-level solutions and even fewer that have a track record of having done this. In the future, pharma, biotech and medical device companies and CROs need to work together more closely to develop customized partnership solutions that are fit-for-purpose for successful portfolio delivery to the benefit of patients worldwide.
This blog is an edited version of “Global Outsourcing Strategies” which appeared in Contract Pharma on 9th November 2018. To view the full article, please visit https://www.contractpharma.com