In early October 2025, TripleTree attended SCRS 2025 alongside the industry’s most prominent thought-leaders, innovators, and clinical research professionals. The dynamic dialogue revolved around a predominant theme - cautious optimism – which we feel perfectly encapsulates the current state of the clinical trial ecosystem. As an active M&A advisor in the clinical trial outsourcing landscape, TripleTree is excited to share key observations and collective learnings from the SCRS summit, including recent deal activity, key themes shaping the industry, and insights into future clinical site M&A activity.
The Pulse of the Market: Cautious Optimism and Strategic Therapeutic Focus
While 2025 has seen its share of clinical trial delays and cancellations, there's a growing belief that the tide is turning. In a recent report released by IQVIA, clinical trial start volumes have fully returned to pre-pandemic levels, with 5,318 trials initiated in 2024 and continued momentum into 2025 with a 20% increase in trial starts in the first half vs. 2024. In the capital markets, we are seeing signs of a slow emergence from the ‘biotech winter’ and meaningful momentum for funding of later stage, de-risked assets. As a result, public market confidence has trended positively from the trough in Q2’2025 with key public biotech and pharma clinical development indices all meaningfully improving year-to-date, including BBC (+31.6% YTD), XBI (+21.9%), and IBB (+18.2%). Complemented by record amounts of dry powder raised by early-stage investors, more biotech M&A and licensing activity, and an expectation for the IPO market to resurge in 2026, there is a sense of cautious optimism that the overall market momentum will accelerate.
At the therapeutic level, we are noticing the optimism and strategic focus directed into more complex therapeutic classes including cardiometabolic diseases, neurological/psychiatric conditions (including inpatient studies), Central Nervous System (CNS) disorders, infectious diseases, and immunology. With significant unmet patient needs, more complex protocols and endpoints, and advancing technologies (e.g. advanced biomarkers), the promising array of new compounds across these categories offers a unique, long-term growth opportunity for capable research sites. And while vaccine studies will undoubtedly remain a portion of site networks’ profitability over the coming years, a heavy reliance on vaccines for growth can pose risks to sustainable growth and investor interest.
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Therapeutic Spotlight: Global Oncology |
There is a broad and enduring desire for both site networks and CROs to play a bigger part in oncology, the largest therapeutic category. The sheer volume and complexity of cancer research continue to make it a cornerstone of the clinical trial landscape, offering consistent opportunities for sites with the necessary expertise and infrastructure.
TripleTree sees a variety of strategic opportunities for investors and research sites to participate in a growing portion of the oncology research spend. For example, Phase I in oncology has continued to expand in scope, running beyond dose escalation studies and into expansion cohorts for Phase 2-like safety profiling on the Phase I protocol. This expands the potential volume of patient enrollments for sites while providing sponsors with a quicker, less costly pathway to accelerated approval if the early phase clinical data is compelling.
With a dearth of Phase I oncology sites across the globe, there is meaningful room for market entry. Separately, sponsors are seeking access to community-based or embedded research sites with broader and quicker reach to oncology patients in addition to new international markets with large, limited pre-treatment oncology patient populations. In totality, we expect a continued shift in oncology trial site selections from the traditionally dominant Academic Medical Centers (AMCs) into a variety of other sites models and geographies.
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Emergence of Embedded Research Models: Delivering Research as a Care Offering |
The conversations at SCRS and recent deal activity highlighted a growing desire from health systems, providers, traditional sites and even sponsors to scale embedded research models (or interchangeably referred to as integrated research). Eager to capture the economic opportunities and enhance patient care, providers and health systems have large, dedicated patient populations that are rarely aware of clinical research as a care pathway during a conventional healthcare visit. This patient-centric movement challenges traditional site models, forcing a re-evaluation of how research can be seamlessly woven into routine clinical practice to meaningfully broaden patients’ access to clinical research opportunities. Moreover, sponsors and CROs understand the potential benefits of embedded models to streamline recruitment, improve enrollment diversity, and reduce the patient burden.
Within this evolving landscape, a key contrast is emerging between platforms that are services or FSP-led vs. technology-first. This isn't an either/or proposition, but rather a spectrum where organizations are strategically positioning themselves to leverage the best of both worlds – human expertise coupled with technological efficiency. Across the market, there are multiple approaches being employed by embedded research platforms, including a focus on health systems vs. provider practice research enablement, and various economic arrangements (e.g. revenue share, cost-plus, profit share, joint ventures, etc.). While offering research within a traditional care setting sounds relatively simple, the complexity of executing embedded clinical research at scale presents hurdles that many of the emerging platforms are still navigating. However, TripleTree believes that embedded site platforms employing varying models will continue to innovate, adopt new technologies, and capture more trial activity, and it i’s our expectation that sponsors and CROs will include more embedded sites into feasibility processes and protocol selections.
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Imperative and Innovation of Trial Recruitment |
| Underpinning our discussions at SCRS and our ongoing market interactions around clinical was a resounding consensus: recruitment is more important than ever. The days of simply casting a wide net with "top of the funnel" services like generic banner ads are fading. Instead, the industry is witnessing a significant shift towards more targeted engagement and end-to-end patient qualification platforms. Platforms capable of delivering qualified, eligible patients with meaningful pull-through to randomization and ongoing engagement to maximize on-study patient retention have seen continued growth amidst a tough cycle for the space over the last couple years. TripleTree has held countless discussions with other industry players seeking to leverage their proprietary patient databases, patient engagement technologies, and predictive patient profiling capabilities to enter the clinical trial recruitment space. Longitudinal patient profiles can provide the pathway to target patients based on clinical endpoints, not just pre-screening criteria, and fundamentally transform how patients are targeted. In parallel with the strategic shifts shaping the industry briefly highlighted above, TripleTree believes the long-term horizon for innovation around patient recruitment for both clinical trials and pharma commercial programs is extremely bright. |  |
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Blurred Lines: CROs, Sites, and the Decentralization Paradigm |
Perhaps one of the most intriguing and rapidly evolving themes in this landscape is the blurring of lines between CROs and Sites. The rise of decentralized and/or hybrid-designated clinical trials has fundamentally altered the traditional roles and responsibilities within the ecosystem. Historically, CROs have been the primary technology managers in trials, but this is changing. As sites embrace more technology-driven solutions, their roles in data capture, patient engagement, and even technology integration are expanding.
The respective roles in recruitment are also a significant point of discussion. While CROs traditionally manage large-scale recruitment efforts, sites are increasingly taking on more targeted, localized recruitment strategies, leveraging their community ties and understanding of patient populations. As a result, there's an attempted unbundling of non-trial site services, with CROs increasingly contracting third-party services for aspects like nursing, in-home phlebotomy, and other direct-to-patient services. This decentralization of services creates new opportunities for specialized providers but also raises questions about data capture, oversight, and maintaining a cohesive trial experience.
Clinical Trial M&A Market Perspectives
The M&A landscape in the clinical trial sector through 2025 has been, as anticipated, somewhat muted. There have been some high-profile, larger-scale platform deals such as Headlands' acquisition by THL, NEXT Oncology’s acquisition by IQVIA, and Flourish Research's acquisition of Valkyrie, signaling a continued appetite for consolidation of high-quality platforms among well-capitalized players. However, most of the other M&A activity has consisted of smaller site tuck-ins – strategic acquisitions designed to expand geographic reach or specific therapeutic capabilities.
- Looking ahead, the consensus among market watchers is that 2026 will likely see an uptick in site M&A activity. However, the bolder prediction is that it will be even more active for site and CRO enablement services, technologies, and eClinical technologies. This aligns with the broader industry trend of technology adoption and the need for robust digital infrastructure to support increasingly complex and hybrid trials. Investors are keenly aware that efficient operations, streamlined data management, and effective patient engagement are critical drivers of success, making the companies that provide these solutions highly attractive.
- Despite the recent cyclical shifts, the long-term tailwinds are expected to drive a rising tide for most site networks in the next few years. As the biopharma pipeline continues to grow and innovation re-accelerates, the demand for well-run, efficient clinical trial sites will only intensify. The current cycle, while challenging, is seen by many as a weeding-out period, strengthening the foundations for future growth.
- Finally, the massive landscape of private-equity-backed site networks remains a significant theme. These organizations, flush with capital and driven by strategic growth objectives, are poised to be major players in the next wave of consolidation and innovation.
The questions on everyone's mind:
- What's next for the scaled PE-backed platforms?
- Will they continue their aggressive acquisition strategies, focus on organic growth and operational optimization, or begin to employ new research models or technologies to drive differentiation?
Their decisions will undoubtedly shape the future structure and competitive dynamics of the clinical trial site market.
Resilient Innovation on the Horizon
The SCRS 2025 conference painted a picture of an industry in transition, characterized by both challenges and immense opportunities. The cautious optimism is well-founded, reflecting a sector that has weathered recent storms and is now strategically repositioning itself for future growth.
With a renewed focus on complex therapeutic areas, evolving operational models, intensified patient recruitment strategies, and the blurring lines between traditional roles, the clinical trial landscape is undergoing a profound transformation. As M&A activity is poised to rebound, particularly in the realm of enablement solutions, the stage is set for a period of resilient innovation and strategic expansion, ensuring that the vital work of bringing new therapies to patients continues to accelerate.
At TripleTree, we’ll continue to provide insights on market-leading trends and conversations that are shaping healthcare. Read more about what's transforming the healthcare landscape in previous TripleTree publications or reach out for more information.
