The Strategic Emergence of Site Networks in Clinical Research

Gerri Gallagher, Head, US Site Engagement, GSK

Adam Kinsey, Associate VP, Clinical Operations and Regional Head, North America, Merck

Mark Scullion, CEO, Atlas Clinical Research

Samir Shah, Principal, Shah Pharma Consulting Services

In recent years, the US clinical research landscape has witnessed a pronounced shift toward the consolidation of clinical trial sites into larger, more integrated site networks. This trend reflects a strategic response to multiple pressures, including the increasing complexity of clinical trials, the need for heightened operational efficiency, and the financial challenges faced by individual sites. As trials become more multifaceted, with intricate regulatory requirements and the demand for diverse patient populations, the ability to standardize processes and scale operations effectively has become paramount. Site consolidation offers a means to meet these demands, providing a structured and unified approach that enhances the overall management and execution of clinical trials.

The emergence of site networks has not occurred in isolation; it is part of an ongoing transformation within the clinical research industry driven by several key factors, including but not limited to the growing emphasis on patient diversity, the need to reduce trial timelines, the increasing scrutiny from regulatory bodies, and increasing operational costs. As a result, the consolidation of clinical sites into networks is seen as a necessary evolution, aimed at addressing these challenges while improving the efficiency and effectiveness of clinical trials.

This report seeks to explore the landscape of clinical site networks, assess the level of industry awareness, and discuss the potential advantages and disadvantages of consolidation. In doing so, it will examine the strategic implications for development operations and portfolio allocation, offering a comprehensive framework for sponsors and contract research organizations (CROs) to navigate this evolving environment.

Overview of the survey: Awareness and perceptions

To gain a deeper understanding of the industry’s awareness of site network consolidation and its perceived implications, a survey was conducted in collaboration with Linking Leaders, a platform that connects clinical operations and outsourcing leaders across the pharmaceutical, biotechnology, and CRO sectors. This survey targeted a diverse group of high-level clinical operations professionals from small to mid-sized pharmaceutical companies, CROs, and biotechnology firms. The primary goal was to gauge the level of awareness regarding the rising emergence of site networks and to assess the perceived benefits and challenges associated with this trend.

Survey purpose and participants

The survey aimed to test the level of awareness among industry leaders about the consolidation of clinical trial sites into networks. Participants included a broad spectrum of leaders, encompassing various roles and organizational sizes, which provided a comprehensive view of how different sponsor types perceive site consolidation and its strategic implications. This diverse participant base was crucial in capturing a wide range of perspectives, ensuring that the survey results reflect the varied realities of the clinical research landscape.

The survey was designed to explore several key areas: the extent of familiarity with site networks, the perceived advantages and disadvantages of consolidation, and the potential impact on clinical trial operations. Sample questions included, “Are you aware of the trend toward consolidating clinical research sites into site networks?” (see Figure 1 below); And “If you have used site networks, how likely are you to increase the percentage of your work with site networks in the next twelve months?” By focusing on these areas, the survey sought to provide a nuanced understanding of how site network consolidation is perceived within the industry and to identify the strategic considerations that CROs and sponsors—perhaps especially sponsors—must address when selecting a site network with whom to partner.

Survey findings: Awareness levels

The survey findings revealed that a significant portion of industry leaders are aware of the ongoing trend toward site network consolidation. Among the respondents, especially from the sponsors, there was a high level of familiarity with the concept of site networks, and many had already integrated these networks into their clinical trial operations. This indicates that site network consolidation is not only well recognized but is also being actively engaged with by a substantial segment of the industry.

However, the survey also highlighted a degree of caution among smaller organizations. These respondents expressed concerns about the operational complexity and potential costs associated with consolidation. For these companies, the decision to engage with site networks may be influenced by a need to balance the potential benefits of consolidation with the challenges of integrating into larger, more complex networks.

This finding suggests that while site network consolidation is broadly recognized, its adoption may vary depending on the size and resources of the organization.

Perceived pros and cons

The survey identified several potential advantages of site consolidation, which were widely acknowledged by the respondents. These include potential for improved study start-up times, enhanced patient recruitment capabilities, and more efficient resource allocation across sites. Respondents noted that the ability to standardize processes and centralize operations could lead to higher quality and more consistent trial outcomes. Site consolidation was also seen as a way to enhance patient diversity in trials, an increasingly important consideration for ensuring the generalizability of trial results.

Lastly, the respondents raised the fact that site networks could leverage greater negotiating power with sponsors/CROs and could provide opportunities for professional development, and, therefore, possibly better site staff retention, given the size and growth potential.

On the other hand, the survey also uncovered concerns regarding the potential downsides of site consolidation. One of the primary concerns was the risk of over-centralization, which could result in the loss of localized expertise that is critical for patient recruitment and retention, particularly in diverse or underserved populations.

Executives also expressed worries about the potential reduction in competition as independent trial sites are absorbed into larger networks. This could lead to higher costs and a decrease in service quality, as the competitive pressure that drives innovation and improvement may diminish. Another significant concern was the potential loss of autonomy for individual sites within these networks. This loss of autonomy could impact the ability of sites to tailor their services to the specific needs of their patient populations and maintain strong relationships with local healthcare providers.

Overall, the survey underscored the importance of carefully weighing the potential benefits and drawbacks of site network consolidation. While the operational advantages are clear, there are also significant risks that must be managed. Sponsors and CROs will need to consider these factors as they make strategic decisions about how to integrate site networks into their clinical development operations.

Setting out a taxonomy of sites and networks

As site networks become more prevalent, it is increasingly important for sponsors to understand the different characteristics of sites and networks. A well-defined taxonomy of sites and networks can provide a structured approach to site selection, helping sponsors to identify the most suitable sites for their clinical trials based on specific attributes and strategic goals.

Understanding site and network characteristics

Sites and networks in the clinical research landscape vary widely in terms of their characteristics, including ownership structure, geographic footprint, patient diversity, and operational capabilities, to name a few. These characteristics can have a significant impact on the success of a clinical trial, influencing everything from patient recruitment to data quality and regulatory compliance. For sponsors, understanding these differences is crucial to making informed decisions about which sites to engage for their trials.

For instance, some site networks may be owned by large healthcare organizations or academic institutions that may be able to offer extensive resources and access to diverse patient populations. These networks may be well-suited for large, multi-site clinical trials that require significant operational infrastructure.

In contrast, smaller, independent sites may offer specialized expertise in specific therapeutic areas or patient populations, making them ideal for niche studies and/or early-phase trials.

Landscape of sites

The current landscape of clinical trial sites includes a diverse array of entities, ranging from large academic research organizations (AROs) to smaller, independent sites and integrated research organizations. Each type of site offers unique advantages and challenges, depending on the specific requirements of the trial and the strategic objectives of the sponsor.

For instance, AROs are often associated with large academic medical centers and have extensive experience in conducting clinical trials. They may offer access to cutting-edge research facilities and a highly specialized workforce, but they can also be more expensive and less flexible than smaller sites. On the other hand, independent sites, which may be part of physician practices or community clinics, can provide more personalized care and may be better positioned to engage with local patient populations. However, these sites may lack the resources and infrastructure needed for larger, more complex trials.

Understanding the strengths and weaknesses of these different site types is critical for successful site selection and trial execution.

When selecting sites, sponsors must consider the specific needs of their trials, including the therapeutic area, patient population, and regulatory requirements.

Key attributes of sites and networks

A comprehensive taxonomy of sites and networks should consider several important attributes (see Table 1 below), including:

• Ownership structure: Whether the site is independently owned or part of a larger network or organization.
  Proven performance: The track record of a site in conducting clinical trials with quality.
• Infrastructure: The capacity of a site to manage critical support, such as contracts, budgets, IT, and data entry.
• Geographic footprint: The location of the site and its ability to recruit patients from diverse populations.
• Integration with centralized operations: The degree to which the site is integrated with centralized operations, including data management, regulatory compliance, and patient recruitment.
• Patient diversity: The site’s ability to recruit and retain a diverse patient population, which is increasingly important for ensuring the generalizability of trial results.

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These attributes can help sponsors assess the potential of a site or network to meet the specific needs of their trials. For example, a site with a robust infrastructure and centralized operations may be better suited for large-scale, multi-site trials, while a smaller, independent site may be ideal for niche studies requiring specialized expertise.

Potential strategic implications

The consolidation of clinical trial sites into networks presents several strategic implications for sponsors, CROs, and the broader clinical research industry.

Considerations for site selection

As site networks become more prevalent, sponsors must consider how to select sites that align with their strategic objectives. This may involve balancing the operational efficiency of larger networks with the need for localized expertise and patient engagement. For example, while larger networks may offer standardized processes and centralized operations, they may also lack the flexibility needed to address the unique needs of specific trials or patient populations. Sponsors will need to carefully evaluate these trade-offs when selecting sites.

Additionally, sponsors should consider the potential impact of over-centralization on trial flexibility and patient recruitment. Over-centralization could lead to a loss of localized expertise and the ability to engage with diverse patient populations, which could negatively impact trial outcomes. To mitigate these risks, sponsors may need to develop strategies that balance the benefits of consolidation with the need for flexibility and localized engagement.

Relationships with CROs

The rise of site networks may also affect relationships between sponsors and CROs. As site networks become more integrated and centralized, CROs may wish to adapt their operational models to align with these changes. This could involve greater collaboration and communication between sponsors, CROs, and site networks to ensure that trials are conducted efficiently and effectively.

As an example, CROs may need to work more closely with site networks to develop standardized processes and ensure consistent data quality across multiple sites. This could involve the use of centralized data management systems, standardized protocols, and shared resources. By working together, sponsors, CROs, and site networks can improve trial efficiency and reduce the risk of delays or data quality issues.

In addition, CROs mays may want to develop more strategic partnerships with site networks, leading to long-term collaborations. These relationships can drive innovation in trial design, patient engagement, and data management.

Evolving site-sponsor relationships: Portfolio allocation?

Finally, the consolidation of sites into networks may lead to an evolution in site-sponsor relationships. As site networks become more centralized/standardized, new possibilities open for portfolio-level allocation. This approach could help optimize resource utilization and ensure that trials are conducted at the most suitable sites for each phase of development.

A sponsor may choose to allocate early-phase trials to smaller, more flexible sites that can quickly adapt to changing trial requirements. Later-phase trials, on the other hand, may be allocated to larger networks with the resources and infrastructure needed to handle complex, multi-site trials. By adopting a portfolio-level approach to site selection, sponsors can maximize the efficiency and effectiveness of their clinical development operations. The effectiveness of site networks in supporting portfolio-level allocation will depend on the specific circumstances and needs of the sponsor.

Sponsors may find it beneficial to work more closely with site networks to develop shared goals and objectives, establish clear expectations for trial conduct, and ensure that data quality and patient recruitment standards are met. Engaging with site networks can lead to strategic long-term partnerships that offer deeper insights into specific therapeutic areas, patient populations, and regional regulatory requirements. By building stronger partnerships with site networks, sponsors can improve the efficiency and effectiveness of their clinical trials and enhance the likelihood of trial success.

Thoughts on the future

Over the course of the next few years, we will likely see even more consolidation in the independent site network space, most likely to private equity and CROs: those that have their own site networks today, or those that enter the market to develop those strategic capabilities.

Large and mid-size pharmaceutical organizations might be inclined to establish direct contracts with site networks driven by two factors: 1) a shift in outsourcing trends, moving from comprehensive outsourcing solutions toward functional provider solutions or blended-point solutions in which sponsor companies have more control; and 2) a growing interest in fostering more direct and intimate relationships with investigators.

Drawing parallels with the consolidation and maturation observed in the CRO sector, site networks may stand to gain and grow from this potential shift in several ways:

• A rise in strategic relationships where large and mid-size organizations will establish more comprehensive key performance indicators to ensure patient enrollment. This could potentially reduce existing sunk costs, creating a mutually beneficial situation for all parties. In addition, more enduring business models could emerge, focusing on allocating portions of the portfolio to site networks, as opposed to the “study-by-study” approach. However, this would necessitate substantial change management from sponsor companies in terms of their current work allocation and risk management parameters.
• Site consolidation outside the US will start to increase, as site networks will want to have a seat at the table for global trials. While it may be fragmented in nature, at first, opportunities exist in Latin America, Europe, and Asia-Pacific.
• Expansion into adjacent pharma services. As investment organizations and site networks continue to focus on value creation plans outside of site network consolidation, there may be expansion into pharma services, such as protocol and scientific support, data management, and possibly an independent monitoring workforce. These services could compete for CRO market share.
• Risk sharing. Meeting recruitment and retention goals has always been a significant concern for any organization conducting clinical trials. Sponsor companies and CROs spend considerable time and money trying to avoid selecting individual sites that will ultimately fail to meet enrollment expectations. Despite these efforts, site failure rates remain high. Many projects are forced into a “rescue” situation where new and/or replacement sites are engaged mid-trial. Additionally, inactive sites are often kept open for too long. This can lead to large budget overruns and potential delays to marketing approval applications. Site networks offer a potential opportunity to handle this critical aspect of trial operations differently through a risk-sharing relationship. Rather than allocating a specific number of sites to networks on specific studies at a cost per site, could there be a shift where site networks are contracted to meet recruitment and retention goals across a protocol or program at a relatively fixed cost?

In summary

The consolidation of clinical trial sites into networks represents a significant shift in the clinical research industry. While this trend offers several operational advantages, it also presents challenges that must be carefully considered. By understanding the characteristics of different sites and networks, sponsors can make informed decisions about site selection, align their strategies with broader industry trends, and ultimately improve the success of their clinical trials.

As the clinical research landscape continues to evolve, sponsors and CROs will need to adapt their strategies to navigate the complexities of site network consolidation. By carefully considering the potential benefits and drawbacks of consolidation, and by developing strategies that balance efficiency with the need for localized expertise and flexibility, sponsors can optimize their clinical development operations and enhance the likelihood of successful trial outcomes.

Gerri Gallagher is Head, US Site Engagement, GSK; Adam Kinsey is Associate VP, Clinical Operations and Regional Head, North America, Merck; Mark Scullion is CEO, Atlas Clinical Research; and Samir Shah is Principal, Shah Pharma Consulting Services

Acknowledgement: This report would not have been possible without the support and contributions ofLesly Atlas and Pam Sobotka of Linking Leaders; Anne Lawrence, Head, US Clinical Operations, GSK; Sean Jensen, Director, Site Relationship Management, Merck; and Gloriana Ordoñez Carboni, Atlas Clinical Research.

* The views and opinions expressed in this report are solely those of the authors and do not express the views or opinions of their employers.