By: ABRS- Academic Team
Introduction
As clinical trials continue to increase in complexity, sponsors are adopting more flexible operating models to access specialized expertise, scale resources efficiently, and maintain continuity across global programs. Functional Service Provider (FSP) models have become a central component of this shift, enabling sponsors to embed dedicated capabilities within their organizations while retaining strategic control.
Regulatory authorities have consistently emphasized that, regardless of the operating model selected, sponsors remain ultimately responsible for trial quality, data integrity, and participant protection. In this context, operational governance has emerged as a critical enabler of quality—providing the structure, clarity, and oversight needed to ensure that distributed teams and functions operate in a controlled and compliant manner (FDA, 2020; ICH, 2016).
What Operational Governance Means in an FSP Context
Within an FSP model, operational governance extends beyond traditional project management or contractual oversight. It refers to the defined framework of roles, decision rights, escalation pathways, and performance oversight mechanisms that guide how sponsor and FSP teams work together across the trial lifecycle.
From a regulatory perspective, ICH guidance makes clear that delegation of trial-related activities does not equate to delegation of responsibility. Sponsors are expected to maintain adequate oversight of all critical processes, including those performed by external partners, through documented governance structures and controls (OECD, 2021; MHRA, 2022).
In practice, effective operational governance in FSP models clarifies accountability across functions such as clinical operations, data management, monitoring, and regulatory affairs. It establishes how decisions are made, how risks are identified and escalated, and how performance is measured—creating a shared operating rhythm that supports both compliance and efficiency.
Why Governance Directly Impacts Quality and Compliance
Regulatory inspection findings across regions have repeatedly highlighted deficiencies related to oversight, documentation, and sponsor control of delegated activities. According to regulatory guidance, the absence of clear governance is often interpreted as insufficient oversight, even when operational tasks are being performed competently by service providers (MHRA, 2022).
In FSP models, where resources are embedded within sponsor teams but may follow different management or reporting structures, governance becomes essential to maintaining consistency in quality expectations. Defined governance processes support alignment on standard operating procedures, training requirements, and issue management approaches, reducing variability across studies and regions.
Moreover, governance frameworks enable sponsors to apply proportionate, risk-based oversight—focusing attention on critical-to-quality activities and emerging risks rather than relying on retrospective corrective actions. This aligns directly with regulatory expectations for proactive quality management and continuous oversight throughout the study lifecycle (TransCelerate BioPharma, 2023).
Enabling Scalable and Resilient FSP Operations Through Governance
As sponsors expand the use of FSP models across portfolios, therapeutic areas, and geographies, scalability and operational resilience become increasingly critical. Governance plays a central role in enabling this scale by providing a consistent structure that supports growth without introducing fragmentation, variability, or loss of oversight.
From an operational perspective, governance frameworks allow sponsors to standardize how FSP resources are onboarded, trained, and integrated into existing trial teams. Industry guidance highlights that clear role definitions, standardized performance metrics, and harmonized escalation pathways are essential for maintaining consistency as programs expand (OECD, 2021). Without these elements, scaling FSP engagements can amplify inefficiencies and increase compliance risk rather than mitigate them.
Resilience is equally dependent on governance maturity. Regulatory inspection experience summarized by the UK Medicines and Healthcare products Regulatory Agency indicates that disruptions such as staff turnover, organizational restructuring, or rapid portfolio changes frequently expose weaknesses in oversight and documentation practices (MHRA, 2022). Robust governance structures help mitigate these risks by ensuring continuity of decision-making, preserved institutional knowledge, and documented accountability, even when personnel or vendors change.
In addition, well-defined governance enables proactive performance and risk monitoring across distributed FSP teams. Industry-led frameworks developed by TransCelerate BioPharma emphasize that scalable oversight relies on routine review of operational indicators, trend analysis, and structured issue management processes rather than ad hoc intervention (TransCelerate BioPharma, 2023). These practices support early identification of emerging risks and allow sponsors to adjust oversight intensity in a controlled and proportionate manner.
Importantly, governance also supports long-term sustainability of the FSP model by reinforcing alignment between operational execution and quality expectations. When governance is embedded as part of the operating model—not layered on reactively—it enables sponsors to scale capabilities, adapt to changing trial designs, and maintain regulatory confidence across increasingly complex clinical research environments.
Conclusion:
In modern clinical research, quality is no longer driven solely by processes and controls—it is enabled by how organizations govern their operations. As FSP models continue to evolve, operational governance has become a critical mechanism for aligning distributed teams, maintaining regulatory oversight, and supporting consistent quality outcomes.
Regulatory authorities are clear that sponsors must retain control and visibility over all trial activities, regardless of how work is structured or delegated. When operational governance is intentionally designed and embedded within FSP models, it enables sponsors to meet these expectations while benefiting from flexibility, specialization, and scalability. In this way, governance is not an administrative layer, but a foundational element of compliant, resilient, and high-quality clinical trial execution.