As clinical trials grow increasingly complex, the traditional outsourcing models are being replaced by more specialized approaches. For decades, full-service outsourcing (FSO) models dominated the clinical development space, with sponsors delegating the entirety of trial responsibilities to a single contract research organization (CRO). However, as trials have become more complex and therapeutic areas demand specialized expertise, the functional service provider (FSP) model has emerged as a preferred approach for many pharmaceutical sponsors.
A recent post by Fierce Biotech made the point that the transition from FSO to FSP models is accelerating across clinical development. A 2023 survey reported that 41% of biopharma and biotech leaders increased their reliance on FSP outsourcing, compared to 27% who maintained FSO models (Fierce Biotech). Three factors largely drive this shift:
While the benefits are attractive, this approach significantly increases coordination and administrative burden on clinical operations teams, requiring them to manage multiple vendors directly and ensure alignment across all trial components.
Clinical trials involve increasingly complex outsourcing arrangements, requiring sponsors to directly manage a broad set of specialized suppliers responsible for various trial components.
Sponsors working within an FSP model must ensure that multiple suppliers, often with highly specialized capabilities, work together to deliver on trial milestones. This requires clinical operations teams to oversee various workflows, budget changes, synchronize timelines, and manage handoffs across suppliers—tasks traditionally handled manually through spreadsheets, emails, and fragmented documentation. The lack of a centralized system to facilitate integration and coordination increases the risk of delays, errors, and misalignment between sponsors and suppliers. It can also divert valuable resources away from strategic trial oversight, as teams are forced to focus on administrative tasks to keep the study moving forward. While FSP offers flexibility and access to specialized expertise, it places far greater administrative responsibility on sponsors to integrate and coordinate outsourced functions.
Without the right technology to streamline these business processes, sponsors face additional challenges in achieving visibility across all clinical trial components. Financial controls such as budget tracking, change order approvals, and rate card compliance become increasingly difficult when managed across a growing supplier base. This complexity compounds with the scale of clinical trials, particularly in multi-site or multi-phase studies, where inefficiencies in coordination can significantly impact study timelines and costs.
For a sponsor managing a Phase 3 oncology study—often involving dozens of sites, Central Labs, imaging providers, and niche ancillary CROs—the operational complexity can delay study initiation and execution. Key process challenges include:
These challenges are common across the full life cycle of clinical trials and highlight the critical need for a digital supplier orchestration platform built for clinical development operations.
The Science Exchange Clinical Development Supplier Orchestration Solution addresses these pain points head-on, offering sponsors a centralized platform to manage the complexities of FSP and FSO models. Key features include:
For sponsors transitioning to an FSP model, Science Exchange’s new orchestration platform provides the operational backbone needed to manage an expanded supplier ecosystem effectively. By digitizing intake, contracting, and budget validation processes, sponsors can minimize administrative burdens, reduce costs, and focus on strategic trial oversight.
The platform also supports FSO models by enabling clinical operations teams to digitize the full-service CRO budget management process, ensuring streamlined collaboration and accountability. For example, in Central Labs—a critical area for early adoption—the platform automates study-specific budget validation and integrates seamlessly with existing systems, significantly reducing study startup times.
As the industry continues to embrace FSP models, the need for robust orchestration technology will only grow. Sponsors face increasing pressure to deliver trials faster, with greater efficiency and precision. Science Exchange’s solution not only addresses today’s challenges but also lays the foundation for a future where supplier management processes are entirely digitized and optimized.
To learn more about how Science Exchange transforms clinical development outsourcing, don’t miss our webinar: Supplier Orchestration in Action: Modernizing Clinical Operations through Technology. Register now.
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