For years, conversations about clinical research sites have revolved around a familiar set of metrics: enrollment numbers, geographic reach, principal investigator counts, and study experience. Those statistics matter, but according to Kurt Mussina, CEO of Paradigm Clinical Research, they only tell part of the story. The more important question, he argues, is one the industry rarely asks: How does a site actually operate?
Mussina believes the clinical research industry has become overly focused on quantitative measures while overlooking the operating strategies that ultimately drive performance. Sponsors and CROs routinely ask about enrollment capacity and site footprint, but in his 15 years leading site organizations, he says they rarely ask about operating models, organizational structure, or how a site business executes research consistently across locations.
That gap in understanding is increasingly significant as site organizations grow more sophisticated and diverse. While many stakeholders view sites as largely interchangeable, Mussina argues that major differences exist beneath the surface. Some organizations operate as networks of independent locations, others function as site management organizations (SMOs), and still others employ centralized operating structures that allow them to standardize processes, technology, and oversight across multiple locations. Those distinctions can profoundly affect execution, quality, and scalability.
“The industry has spent years talking about scale,” Mussina said, a topic he’s covered at length in a recent series of articles in Clinical Leader covering site operating models. “Now it’s time to talk about execution.”
The Missing Vocabulary Problem
A major obstacle to having that discussion is the absence of a common taxonomy for site organizations.
According to Mussina, the industry lacks a shared vocabulary to describe and compare fundamentally different site operating models. While pharmaceutical companies and CROs have largely standardized terminology that allows stakeholders to understand organizational structures and capabilities, the site sector has not reached the same level of clarity.
As a result, terms such as “network,” “SMO,” and other labels are often applied inconsistently. Mussina noted that Paradigm is frequently described as a network or an SMO, even though he does not believe either label accurately reflects the company’s centralized operating approach. This inconsistent terminology confuses sponsors and CROs and makes it harder for investors to evaluate site businesses.
Without agreed-upon definitions, stakeholders often compare organizations that operate in fundamentally different ways as though they are direct equivalents. That makes it difficult to assess the strengths, tradeoffs, and execution capabilities of different models.
“There is no perfect model,” Mussina said. “There are just different tradeoffs.” Understanding those tradeoffs requires a common language that the industry currently lacks.
AMRC and Industry Leaders Push for Alignment
Fortunately, efforts to address the problem are already underway.
Mussina pointed to the Association of Multisite Research Corporations (AMRC) as an important catalyst in developing a more standardized framework for discussing site organizations. AMRC’s work to define categories and establish common terminology is helping move the industry toward a shared understanding of who site organizations are, what they do, and how they operate.
He acknowledged that building consensus will take time. Other industry stakeholders, including investors and market analysts, have attempted to introduce their own definitions over the years, but many have struggled to gain widespread adoption. Meaningful change will likely require sustained reinforcement across the industry until common terms become broadly understood and accepted.
The evolution of terminology in other sectors offers a useful precedent. Mussina noted that even the CRO industry took years to settle on widely accepted definitions and distinctions. The site sector may simply be at an earlier stage of that same journey.
Why Operating Models Matter
Mussina believes a greater focus on operating strategies could benefit nearly every stakeholder in the clinical research ecosystem.
For sponsors and CROs, understanding a site’s operating model may offer better insight into execution reliability, startup timelines, enrollment performance, and operational consistency than headline statistics alone. For investors, operational structure could become an increasingly important due diligence factor as the market matures beyond rapid consolidation and growth.
The discussion also has implications for the industry’s persistent principal investigator retention challenges. Mussina argues that physicians often enter research without fully understanding the operational demands involved, contributing to the well-known “one-and-done” PI phenomenon. A well-designed operating model can reduce that burden by surrounding investigators with specialized research personnel, technology, and support systems that allow them to focus primarily on medical oversight and patient care.
Ultimately, Mussina’s central message is straightforward: statistics still matter, but they should not dominate the conversation.
As the clinical research site industry continues to evolve, he believes stakeholders must move beyond simple measures of size and scale and begin examining the operational strategies that drive outcomes. Doing so will require developing a common taxonomy and shared vocabulary, an effort now being advanced by AMRC and others across the industry. Once that foundation is in place, sponsors, CROs, investors, and investigators alike will be better positioned to evaluate site organizations not just by what they achieve, but by how they achieve it.
