The Future of CROs: Evolving in a Transformational Era

Our present creates our future. In the past, present, and future, we move as one. This sentiment should resonate deeply in the clinical research ecosystem but it does not seem so. Contract Research Organizations (CROs) must evolve to remain relevant, especially given the rise of tech enable Site Networks with endless cash funded by private equity firms. Insights from industry leaders like Philip Raeth and Iddo Peleg reveal how CROs can adapt to thrive in an increasingly competitive and complex landscape. The principle of adaptation also applies to Academic Medical Centers as they navigate the cost-cutting measures soon to be introduced under the Trump administration.

The traditional role of CROs as operational brokers is rapidly becoming obsolete. Sponsors and sites alike are demanding more efficiency, adaptability, and innovation. CROs are at a crossroads: they can either cling to outdated models or transform into strategic enablers driving the industry forward.

The Path Forward: From Brokers to Innovators

To remain indispensable, CROs must pivot their focus. This transformation requires a multi-pronged approach:

1. Leveraging Technology CROs must adopt advanced data integration tools to enhance efficiency and quality. Iddo Peleg, CEO of Yona Link, emphasizes that "EHR-to-EDC streaming is not a feature; it’s a product." This highlights the need for CROs to become experts in seamless data flow between sites, sponsors, and regulatory bodies. By incorporating cutting-edge solutions like AI-driven analytics and EHR-to-EDC integrations, CROs can streamline trial processes, reduce costs, and ensure data quality. Ultimately CROs (as well as all stakeholders for that matter), evolve into tech companies or become irrelevant in my opinion.
2. Supporting Site Networks The rise of professional site networks, capable of handling many traditional CRO responsibilities, is reshaping the clinical research landscape. Philip Wraith notes that these networks excel in patient recruitment, IT infrastructure, and operational efficiencies. Rather than competing with these entities, CROs should focus on collaboration, offering value-added services like regulatory expertise, global infrastructure, and advanced analytics to enhance site performance. CROs have been strategically acquiring site networks over the years as they are likely hedging their bets for a new equilibrium.
3. Specializing in AI-Driven Insights Artificial Intelligence (AI) has become a game-changer in clinical research. From predictive analytics to optimizing trial designs, AI tools offer significant opportunities for CROs to deliver value to sponsors and sites. The ability to provide faster, more reliable data readouts and proactive decision-making will set forward-thinking CROs apart. While there is still more hype that substance, eventually AI will become ubiquitous within our industry and the CROs would be smart to begin investing in these tools now.
4. Enhancing Stakeholder Collaboration CROs must align their services with the distinct priorities of sponsors, sites, and regulators. Peleg highlights the importance of integrating stakeholder needs into solutions: "The secret is putting all the different pieces of the puzzle together." CROs that foster stakeholder collaboration by offering customizable solutions will remain vital partners in decentralized, traditional, and hybrid trial models. More art than science. Creative designer AND traditional laborer.

Addressing Inefficiencies: A Wake-Up Call

The CRO model is burdened by inefficiencies, including bloated management structures and overburdened CRAs managing multiple protocols and sites. As Robert S. Goldman notes, “The future of CROs will involve leaner teams.” Non-billable personnel must decrease, while automation and AI tools must replace repetitive tasks like source data verification (SDV).

Academic Research Organizations (AROs) further challenge the traditional CRO model. Housed within academic institutions, AROs offer high-quality, cost-effective trial execution. With significantly lower overhead, AROs may disrupt the CRO market and become a preferred choice for sponsors.

A Vision for Tomorrow

The evolution of CROs is not just about survival—it’s about shaping the future of clinical research. By leveraging technology, supporting site networks, specializing in AI-driven insights, and fostering collaboration, CROs can redefine their role as innovators.

As Marcus Aurelius observed in Meditations: "The impediment to action advances action. What stands in the way becomes the way."

CROs that adapt to today’s challenges will emerge as strategic enablers, driving efficiencies, increasing accessibility to clinical trials, and ensuring better outcomes for patients and stakeholders alike. Transformation is not optional—it is essential to remaining relevant in a rapidly changing industry.

To watch the interview with Iddo please see below and consider subscribing to my ad free Youtube channel as I am trying to reach the 100k subscriber milestone with your help! The episode will Philip will be released next week and available for all subscribers.