Clinical Researcher—August 2026 (Volume 40, Issue 4)
PRESCRIPTIONS FOR BUSINESS
Denise McNerney; Chris Matheus
Clinical research sites are responsible for turning clinical trial protocols into real-world execution, yet many capable and experienced sites remain underutilized. Despite strong investigator experience and operational infrastructure, sites often encounter barriers related to visibility, feasibility alignment, and fragmented communication across the clinical research ecosystem. Strengthening alignment across sponsors, contract research organizations (CROs), and research sites is essential to improving trial performance and sustainability.
This article examines the structural and operational factors that limit site participation in clinical trials. It outlines common breakdowns in feasibility and site selection processes, explores the increasing operational pressures facing site teams, and highlights practical strategies to improve site readiness and positioning.
Background
Clinical trial performance is frequently discussed in the context of patient recruitment and enrollment timelines. While these factors are critical, they are often downstream effects of earlier decisions, particularly those related to site selection.
Research sites are responsible for implementing protocols, managing patient interactions, ensuring data quality, and maintaining regulatory compliance. Selecting sites that are well aligned with the operational and scientific requirements of a study is therefore fundamental to trial success.
However, many experienced research sites report difficulty gaining access to new study opportunities. This challenge is not always due to a lack of capability. Instead, it often reflects structural limitations in how sites are identified, evaluated, and selected for feasibility.
The Hidden Bottleneck: Site Visibility in Study Selection
While patient recruitment remains a central focus in clinical trials, the process of identifying and selecting research sites receives comparatively less attention.
Many independent and community-based sites, including those with strong performance histories, report they have limited visibility to the sponsors and CROs they wish to attract. As the clinical trial landscape evolves, competition among sites has increased due to consolidation, the expansion of site networks, and the growth of site management organizations.
At the same time, protocols have become more complex. Studies increasingly involve biomarker-driven inclusion criteria, specialized procedures, decentralized or hybrid components, and expanded data collection requirements. The Tufts Center for the Study of Drug Development has documented a steady rise in protocol complexity, including increases in procedures, endpoints, and datapoints collected per trial.{1}
When site selection does not adequately account for operational fit, the downstream impact is predictable. Startup timelines are delayed, enrollment performance becomes inconsistent, and operational burden increases across the study lifecycle.
Where Feasibility Processes Break Down
Feasibility assessments are intended to match studies with sites that have the appropriate patient population, infrastructure, and operational readiness. In practice, however, feasibility processes often function as high-volume administrative exercises rather than comprehensive evaluations.
Several factors contribute to this disconnect:
- Standardized questionnaires that do not capture site-specific strengths or constraints
- Compressed timelines that limit thoughtful responses
- Limited bidirectional communication between sponsors, CROs, and sites
- Misalignment between protocol assumptions and real-world site operations
As a result, feasibility responses may not fully reflect a site’s ability to execute a study. Sites often have limited insights regarding how their responses are evaluated or why selection decisions are made. This dynamic can result in capable sites being overlooked, while selected sites encounter challenges during startup or execution.
The Reality of Site-Level Operational Pressure
Research sites are operating in an increasingly complex and demanding environment. At the same time, many independent sites are facing growing financial and staffing pressures, making efficient study selection more important than ever. Several factors contribute to this pressure:
- More complex protocols requiring specialized training and workflows
- Expanded regulatory and compliance expectations
- Staff shortages and workforce turnover
- The need to manage multiple concurrent studies with competing demands
Recent industry analyses have highlighted growing workload and resource strain at the site level, particularly as trial complexity and administrative requirements continue to increase.{2} These pressures directly affect a site’s ability to respond to feasibility requests, pursue new opportunities, and maintain operational readiness.
For example, a site may have the clinical expertise and patient population required for a study, but limited staff capacity at a given time. Conversely, feasibility responses may reflect theoretical capability rather than current operational capacity. Understanding these dynamics is essential for improving the accuracy and usefulness of feasibility evaluations.
What High-Performing Sites Do Differently
Despite these challenges, some sites consistently demonstrate strong performance in both study selection and execution. Common characteristics of high-performing sites include:
- Strategic feasibility processes that assess study fit before responding
- Clear communication of capabilities, including patient access and prior experience
- Operational infrastructure that supports efficient study startup and execution
- Established relationships with sponsors and CROs
- Realistic assessments of operational capacity and enrollment potential
These sites treat feasibility as a strategic function rather than as a routine administrative task. Instead of pursuing every opportunity, they focus on studies they are positioned to execute successfully. They evaluate whether a study aligns with their capabilities and capacity before committing, supporting more consistent performance during execution.
Reframing Feasibility as a Collaborative Process
Improving site selection requires a shift in how feasibility is approached. Rather than a one-way data collection process, feasibility can be more effective when treated as a collaborative exchange of information. Opportunities for improvement include:
- Earlier engagement with sites during protocol development
- Greater transparency in site selection criteria and decision-making processes
- Inclusion of site input to assess feasibility and operational burden
- More consistent communication between sponsors, CROs, and sites
By incorporating site-level insights earlier and more consistently, stakeholders can better align study requirements with site capabilities. Emerging site-focused communities, such as GLSA Site Nexus, are also creating new opportunities for research sites to share operational insights, strengthen feasibility readiness, and foster more collaborative engagement across sponsors, CROs, and investigators.
Aligning the Ecosystem for Better Trial Execution
Addressing the underutilization of capable sites requires coordinated efforts across sponsors, CROs, and research sites. Sponsors and CROs can improve outcomes by incorporating operational considerations into study design and prioritizing alignment during site selection. While speed remains important, selecting sites based on incomplete or misaligned information can introduce delays later in the study. Research has shown that inefficiencies in site selection and startup are significant contributors to delays in clinical trial timelines.{3}
Research sites can strengthen their positioning by developing clear feasibility strategies, improving communication of their capabilities, and maintaining realistic assessments of capacity. At an industry level, recognizing site capacity as a critical resource is essential. Sites are not interchangeable, and differences in experience, infrastructure, and patient populations should be considered in selection decisions.
Conclusion
Clinical research sites are central to the execution of clinical trials, yet many capable sites remain underutilized due to limitations in visibility, feasibility processes, and communication. Improving how sites are identified, evaluated, and engaged represents a meaningful opportunity to enhance trial efficiency, data quality, and overall performance. By strengthening alignment across sponsors, CROs, and research sites, the clinical research enterprise can better leverage existing site capacity and support more effective and sustainable trial execution.
Key Takeaways
- Site selection is a critical upstream factor influencing trial performance
- Feasibility processes often fail to capture real-world site capabilities
- Operational pressures at the site level affect feasibility accuracy
- High-performing sites treat feasibility and positioning as strategic functions
- Greater collaboration and transparency can improve ecosystem alignment
References
- Getz KA, Campo RA. 2017. New benchmarks characterizing growth in protocol design complexity. Therapeutic Innovation & Regulatory Science 51(3):303–11.
- IQVIA Institute for Human Data Science. Global Trends in R&D 2023: Activity, Productivity, and Enablers. https://www.iqvia.com
- Sertkaya A, Wong HH, Jessup A, Beleche T. 2016. Key cost drivers of pharmaceutical clinical trials in the United States. Clinical Trials 13(2):117–26.
Denise McNerney is a Partner at Global Life Sciences Alliance (GLSA) and a founder of GLSA Site Nexus, a private, site-focused community designed to help clinical research sites increase visibility, strengthen feasibility alignment, access better-aligned study opportunities, and connect with peers and industry experts. She works across sponsors, CROs, and research sites to improve study feasibility, site selection, and clinical trial execution, with a focus on strengthening collaboration across the clinical research ecosystem.
Chris Matheus is a Partner at GLSA with more than 30 years of experience in the life sciences and clinical research industry. He has worked extensively with research sites, CROs, and sponsors, with a focus on improving feasibility alignment, strengthening site engagement, and supporting more effective trial execution.
