he idea that changes in site ownership may disrupt clinical trial operations does not fully reflect how modern clinical research organizations operate. The piece Changes of Site Ownership May Impact Clinical Trial Operations, published in this issue of Global Forum, suggests that acquisitions of independent sites lead to operational instability. However, this perspective overlooks the structured processes and safeguards in place within multisite research organizations to ensure continuity and efficiency in clinical trials.

Yes, private equity (PE) dollars have poured into the clinical trial industry in recent years, but it’s not a destabilizing force. The traditional fragmented approach to clinical trials has long been our industry’s primary source of instability and, contrary to some critiques, outside investment doesn’t threaten sponsors. It actually signals the arrival of much-needed structure, resources, and financial discipline to a sector that has traditionally struggled with inefficiency. Framing independent sites’ mergers and acquisitions (M&A) as a looming risk ignores the fact that more investment and operational consistency will ultimately benefit everyone: patients, investigators, site staff, CROs, and sponsors alike.

This industry’s biggest challenges are not tied to ownership transitions. The real problems stem from outdated trial execution processes, excessive administrative burdens, inconsistent data management, and a lack of standardization.

Understanding Site Ownership Changes

Clinical research is evolving as the demands on sites continue to grow. Protocols are more complex, requiring sites to manage additional endpoints, training requirements, and technology. At the same time, inefficiencies in site operations make it increasingly difficult to keep pace with the needs of modern trials. The traditional site model, which forces investigators to balance clinical care and research, has struggled to adapt. Staffing shortages and investigator burnout are worsening; the overwhelming workload means two-thirds of PIs now leave clinical trials after just one study.

Multisite clinical research corporations (MCRCs) have emerged as a valuable solution. Often established through PE-backed M&A activity, these centrally managed networks offer the infrastructure, scale, and resources needed to streamline clinical trials and enhance patient safety, helping to address common bottlenecks in the process. Before MCRCs, the technology solutions available to sites were created by sponsors and designed to meet the requirements and needs of sponsors’ back-office functions. For the first time, MCRCs are now deploying dedicated staff to manage these technologies in a way that works for sites as well as sponsors, providing solutions that improve operational efficiency, ensuring high-quality data, and creating a more sustainable clinical trial model.

Opportunities for Sponsors

Operational continuity: Trial delivery is the core business of MCRCs, not a secondary responsibility competing with clinical care. Centralized management and processes ensure consistent quality and patient safety across multiple sites and reduce the variability that has long frustrated sponsors. MCRCs also have the scale and resources to invest heavily in proprietary technology (something the industry has been sorely lacking), meaning they can more easily meet the increasingly complex requirements of modern trial protocols.

Data integrity: External audiences might consider sites to be “data rich,” but up close, it’s the kind of wealth that’s tied up in assets no one can quite access: fragmented, outdated, and often incomplete. Many sites still rely on manual processes and obsolete systems, with records so siloed that most sites couldn’t identify the past drug approvals they’ve contributed to. With ready investment and dedicated specialists, MCRCs can and do invest in enterprise-level data systems, proprietary technology, and centralized platforms. This ensures compliance with FDA, ICH, and IRB standards.

Improved data maturity doesn’t just extend to trial data. Traditional site operations struggle with inefficient financial management systems; underbilling, invoicing errors, and a lack of transparency are all commonplace. The opportunity for sponsors and those around them does not come from the risk that financial mismanagement will increase with M&A activity, but that MCRCs will introduce a level of operational precision that challenges inefficiencies that may have gone unnoticed for years.

Regulatory compliance: Compliance is yet another area where MCRCs provide greater consistency and reliability. Clinical research is already subject to rigorous monitoring by the FDA, IRBs, and other regulatory bodies, none of which will tolerate compliance gaps, regardless of changes in ownership. MCRCs are incentivized to uphold the highest standards across their networks because their success depends on executing trials efficiently and maintaining strong regulatory relationships.

While MCRCs have already laid the groundwork for higher standards in training, data management, and operational efficiency, there is still room for improvement across the industry. The FDA has an opportunity to strengthen site qualification requirements, ensuring that all research organizations and their staff meet the level of preparedness and oversight that modern trials demand.

Contractual obligations: The suggestion that site acquisitions introduce instability or that a company would purchase a site and then allow its operations to fail contradicts basic business logic. Site acquisitions are designed to expand trial capacity and improve performance, not introduce risk. The reality is that MCRCs provide stronger oversight, better financial management, and more stable trial execution than traditional, fragmented processes ever have.

Addressing the Wrong Risks

The real discussion should focus on modernizing clinical trial execution to keep pace with industry demands. The inefficiencies of traditional processes are the main obstacle to faster, more effective clinical research. MCRCs are proving that a more structured, scalable approach leads to better outcomes for sponsors, investigators, and patients.

Those who recognize this shift will benefit from faster trials, higher-quality data, better patient safety, and a more sustainable clinical trial ecosystem. The future of clinical research belongs to those who can operate at scale—and MCRCs are proving time and again that they can do just that.