Our functional service provider (FSP) partnerships provide support for a specific function or functions—such as clinical operations or pharmacovigilance—across protocols, medicinal products, a portfolio of studies, or a company.

Our FSP engagements use a flexible mix of systems, processes, oversight and facilities–yours or ours. Contracts are typically allotted by function rather than by study and use cost models based on full-time equivalents (FTEs), units, or time and materials. In the FTE model, our personnel typically work directly within a sponsor’s existing SOPs and platforms.

PPD FSP solutions are a good fit for sponsors who would like closer control and visibility of clinical development operations and who have the infrastructure to assume greater management responsibility. This model also helps sponsors expand their capabilities or capacity using top-tier talent, while, at the same time, leveraging their own internal strengths and capabilities.

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Our full-service outsourcing (FSO) arrangements involve the complete, end-to-end outsourcing of clinical trial tasks—from study startup through database lock—established on a study or protocol basis.

These engagements leverage the full depth of our capabilities as needed—people, systems and processes—to support trials at any phase, from early development through Phase II and III and into peri- and post-approval.

FSO arrangements are ideal for sponsors who lack specific study-related expertise or the resources necessary to execute the trial themselves. Projects are overseen and executed by project managers at the PPD™ clinical research business of Thermo Fisher Scientific, reducing the sponsor’s management burden.

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Our mixed functional service provider (FSP) partnership/full-service outsourcing (FSO) solutions combine the two models to create bespoke solutions tailored to meet your specific needs.

These arrangements often include single or multiple FSP offerings added to an existing FSO arrangement on an as-needed basis—or combined from the very start to create a custom solution. Mixed FSP/FSO models may be delivered from one or multiple CROs; be established by protocol, portfolio of studies, or company; and provide support on both short- and long-term timelines (e.g., complementing a multiple-year FSO partnership with shorter contracted FSP services).

Mixed FSP/FSO models use your systems and SOPs, our systems and SOPs, or a combination of the two, and may be executed through a single—or mixed—cost model. Mixed FSP/FSO models are often used to support sponsors who want greater control of a critical or strategically important clinical development function or when additional resources or specific capabilities are needed to meet unexpected demands to keep projects on time and on budget (e.g., expansion into new regions, therapeutic areas, functions, and services). Mixed FSP/FSO models may also bridge the transition period when shifting from FSO to FSP outsourcing.

Learn more about our mixed FSP/FSO models