By: ABRS- Academic Team
Introduction
The clinical research industry is facing an unprecedented talent challenge. Persistent workforce shortages, high turnover in critical roles, and increasing trial complexity are putting sustained pressure on sponsors’ ability to execute clinical programs efficiently. Traditional outsourcing models—often centered on study-by-study staffing through CROs—have struggled to provide the stability and continuity required in today’s environment.
In this blog, we explore how Functional Service Provider (FSP) models are emerging as a strategic response to these workforce challenges. We examine how functionally aligned, embedded teams help sponsors build resilient clinical organizations, reduce dependency on fragmented staffing approaches, and support long-term workforce sustainability across clinical development portfolios.
Addressing Talent Shortages Through Functionally Embedded Teams
The clinical research industry is currently facing a deepening workforce challenge that threatens the pace and quality of drug development globally. Industry surveys indicate significant shortages of key professionals, including principal investigators and clinical research coordinators, with many organizations reporting staffing gaps that are expected to persist or worsen over time. One analysis found a 41% shortage of PIs and even greater shortages among CRCs, illustrating structural pressure on the workforce that extends beyond temporary hiring cycles and into long-term sustainability issues.
This scarcity is not just a pipeline issue—it also reflects high turnover and burnout, especially in functions central to trial execution such as clinical monitoring and site management. Traditional study-based staffing approaches, often used within CRO contracts, can compound these challenges by rotating personnel frequently between projects, reducing continuity and increasing recruitment pressure. Sponsors and industry bodies alike now recognize that short-term staffing fixes fail to build the kind of stable expertise needed for complex and global trial portfolios.
Functional Service Provider (FSP) models offer a strategic response to this reality by deploying embedded functional teams that operate under the sponsor’s governance and processes rather than being tied to specific studies alone. These teams act as an extension of the sponsor’s internal workforce, maintaining consistent resourcing across programs, reducing disruptive turnover, and deepening domain expertise over time. This functional alignment helps organizations stabilize their workforce, retain knowledge, and ensure that critical roles—such as data management, safety reporting, or monitoring—are staffed by experienced professionals who understand sponsors’ SOPs and quality expectations.
A recent industry perspective on staffing trends further supports the shift toward functional resourcing models. Sponsors seeking to balance flexibility, reliability, and continuity are increasingly turning to FSP outsourcing of clinical operations roles to access broader talent pools with depth of expertise, while retaining strategic control over performance and outcomes. This strategic pivot reflects a broader recognition that workforce resilience is a key competitive advantage in clinical development, especially as global demand for innovation outstrips the available talent base.
In sum, the persistent and widening gap between demand for experienced clinical research professionals and the available qualified workforce underscores why sponsors are embracing FSP models. By embedding skilled teams that remain aligned with sponsor priorities, organizations can mitigate talent shortages, reduce reliance on transient staffing solutions, and build a more resilient operational backbone for clinical research.
Workforce Continuity, Knowledge Retention, and Operational Stability
Beyond immediate talent shortages, sponsors are increasingly concerned about workforce continuity and the loss of institutional knowledge across clinical programs. High turnover rates—particularly among CRAs, project managers, and data specialists—have created operational instability, leading to repeated onboarding cycles, inconsistent execution, and increased risk to timelines and quality. McKinsey has highlighted that frequent staff rotation in clinical operations disrupts learning curves and undermines productivity, especially in complex trials where contextual knowledge and cross-functional coordination are critical to performance.
Traditional CRO delivery models, which are often structured around individual studies, can unintentionally accelerate this fragmentation. Teams are assembled quickly to meet study needs and then redeployed once milestones are achieved, resulting in limited continuity across programs. Over time, this model makes it difficult for sponsors to retain operational knowledge, standardize execution, or build long-term efficiencies. Boston Consulting Group (BCG) notes that operating models overly dependent on project-based staffing struggle to sustain performance consistency, particularly when portfolios span multiple therapeutic areas or geographies.
FSP models address these challenges by enabling longer-term functional alignment, where teams remain engaged across multiple studies and development phases. Because FSP resources are embedded within sponsor processes, systems, and governance frameworks, they accumulate institutional knowledge over time—reducing rework, minimizing handoff errors, and supporting continuous improvement. Industry data from the Association of Clinical Research Professionals (ACRP) reinforce this point, showing that organizations prioritizing role stability and structured career pathways experience lower attrition and stronger performance outcomes compared to those relying heavily on short-term project assignments.
From a strategic standpoint, workforce continuity also supports operational resilience. As pipelines evolve, regulatory requirements shift, or external disruptions occur, sponsors benefit from having experienced teams who understand historical decisions, risk profiles, and sponsor expectations. Deloitte’s 2024 global life sciences outlook emphasizes that continuity in core operational roles is a key enabler of quality, compliance, and delivery predictability—areas where fragmented staffing models consistently underperform.
Ultimately, sponsors are recognizing that workforce continuity is not a “soft” metric, but a strategic asset. By leveraging FSP partnerships that prioritize functional stability and knowledge retention, organizations can reduce operational volatility, strengthen execution consistency, and build a more sustainable foundation for long-term clinical development success.
From Short-Term Staffing to a Sustainable Workforce Strategy
As workforce pressures persist, sponsors are increasingly recognizing that short-term staffing solutions are no longer sufficient to support modern clinical development. Reactive hiring, temporary contractor models, and study-by-study resourcing may address immediate gaps, but they often fail to align with long-term portfolio planning. In fact, McKinsey has observed that organizations relying heavily on ad hoc staffing approaches struggle to scale effectively, as constant resource churn undermines productivity, increases training costs, and limits the ability to build durable operational capabilities.
This realization is prompting sponsors to rethink workforce strategy as a core component of clinical operating models, rather than a downstream executional concern. Boston Consulting Group (BCG) highlights that resilient R&D organizations are those that proactively design operating models around stable functional capabilities, enabling them to flex capacity without sacrificing institutional knowledge or execution quality.
This shift moves the conversation away from “filling roles” and toward building sustainable systems that support long-term development objectives.
FSP models are particularly well suited to this strategic evolution. By enabling sponsors to plan functional capacity across portfolios—rather than at the individual study level—FSP partnerships support predictable resourcing, clearer career pathways, and improved workforce engagement. Industry workforce research from IQVIA underscores that operating models offering continuity, role clarity, and integration into sponsor environments are more attractive to experienced professionals, contributing to improved retention and long-term performance outcomes.
From a leadership perspective, this transition also strengthens alignment between clinical operations, HR, and finance. Sustainable workforce strategies enabled by FSP models allow sponsors to forecast demand more accurately, manage costs more effectively, and reduce reliance on emergency hiring or last-minute outsourcing decisions. Deloitte’s 2025 life sciences outlook notes that organizations integrating workforce planning into their broader clinical strategy are better positioned to absorb pipeline volatility while maintaining execution momentum.
Ultimately, the move from short-term staffing to sustainable workforce strategy represents a fundamental mindset shift. Sponsors are no longer asking how quickly they can staff a study, but how effectively they can build and maintain clinical capabilities over time. In this context, FSP models serve not just as a resourcing mechanism, but as a strategic enabler of resilience, continuity, and long-term clinical development success.
Conclusion:
The growing focus on workforce resilience is reshaping how sponsors think about clinical development execution. As talent shortages persist and trial complexity increases, it has become clear that traditional, study-based staffing models are no longer sufficient to support long-term portfolio success. Sponsors are now prioritizing operating models that promote continuity, knowledge retention, and sustainable access to critical expertise.
As discussed throughout this blog, Functional Service Provider (FSP) models offer a compelling response to these challenges. By enabling functionally embedded teams, FSP partnerships help sponsors stabilize their workforce, reduce disruptive turnover, and retain institutional knowledge across programs. This approach shifts workforce planning from a reactive exercise to a strategic capability—one that supports consistency, quality, and operational resilience.
In this context, organizations such as ABRS (Advanced BioResearch Solutions) illustrate how FSP partnerships can be structured to reinforce sponsor-led clinical operations. By providing embedded functional teams that integrate into sponsor governance, quality systems, and technologies, ABRS supports sponsors in building durable clinical capabilities while maintaining control, oversight, and accountability. Rather than replacing internal teams, this model is designed to strengthen them.
Ultimately, addressing workforce sustainability is not just a talent issue—it is a strategic imperative. Sponsors that adopt FSP models as part of a broader workforce and operating strategy are better positioned to navigate uncertainty, scale effectively, and deliver clinical programs with greater confidence. As the industry continues to evolve, resilient, sponsor-centric workforce models will remain a critical differentiator in clinical development success.