Outsourcing clinical operations has become standard practice for biopharma companies. In most mature markets, you can locate
capable contract research organizations (CROs) for site monitoring, data management, and other common clinical activities.
A study of over 30 biopharma companies by PRTM Management Consultancy found that the vast majority of those companies outsource
nearly 50 percent of clinical monitoring and more than 75 percent of data management when conducting clinical trials in Asia
and other regions.
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In emerging markets, by contrast, there are few standard processes for regulatory activities. Companies have attempted a variety
of approaches to expand and integrate regulatory activities with global clinical trials. Large biopharma companies typically
establish local infrastructure in a given market through organic growth or acquisition. Smaller companies typically secure
local regulatory and safety support as part of a "full-service" model through a CRO.
The "full service" outsourcing model that Amgen traditionally employed generally entails contracting the CRO to complete the
full clinical trial and provide the final results. This includes regulatory filings, patient recruitment, site management,
safety reporting, and data management—an end-to-end package. Over the years, each of these functions has become more specialized
and sophisticated. Contrary to conventional wisdom, full-service CROs have not developed the capability or capacity to provide
true full service and often do not have integrated global coverage. Instead there has been a rise of CROs with country or
regional expertise or even with a focus on a particular therapeutic area. As a way to compensate for this lack of full global
reach, companies rely on a network of regional or disease-specializing CROs, especially in emerging markets. It is not uncommon
that these subcontractors further outsource to others, thus introducing variability in the quality of services. This can lead
to a substantial risk to the sponsoring companies, as the sponsors become further removed from the actual execution of clinical
trials and coordination with the local health authorities in the emerging markets.
All services in a full-service outsourcing model are bundled, so the model also diminishes a company's flexibility to adjust
a particular service that is not working well (for example, late approvals of applications, poor relationships with regulatory
agencies, inefficient capturing of adverse events information, etc.). This liability is particularly pronounced when executing
a low volume of trials. In reality, there are compelling reasons to use the same provider for as many functions as possible,
but the option to choose different providers gives a company more control. Ideally, a company that desires to maintain as
much control as possible when conducting clinical trials in emerging markets needs the flexibility to choose an array of providers
with functional expertise, regional capabilities, therapeutic expertise, regulatory know-how, and local-agency connections.
Amgen has deployed a novel model that allows for this operational control and flexibility to support its clinical trials in
countries where Amgen does not have a presence. This functional service provider (FSP) model facilitates regulatory and safety
activities, ensuring compliance and achieving cost flexibility. The FSP model may help other industry players—especially fast-growing
companies—expand their clinical-trial footprint and manage regulatory and safety activities across the globe, without the
burden and overhead of setting up local affiliates or relinquishing control to CROs (see table below).
Benefits of Amgens Functional Sourcing Model