By Andrew Reina, Chief Revenue Officer
I spent the better part of two decades on the CRO side of clinical research, which gives you a particular vantage point. You see how sponsors evaluate site networks, what they ask for, and (more tellingly) what they don’t. Historically, this is a transactional relationship; a site’s job is to execute the protocol it receives as efficiently and accurately as possible. A sponsor’s job is to design the study, select the sites, and manage the relationship from above. And, until recently, it was a reasonable division of labor.
But the environment sponsors and CROs are operating in now is different. The site landscape is consolidating the way the CRO landscape did in the 1990s, with fragmented independent sites giving way to scalable, integrated operating models. At the same time, protocols are more complex, eligibility criteria are narrowing, and the cost of a poorly matched site or a delayed study is higher than ever. In that context, what sponsors need from sites has changed — but so has what sites can deliver.
The Rise of the Career PI
Traditionally, principal investigators (PIs) conducted trials alongside a busy clinical practice, and it was overwhelming. The “one and done” phenomenon is well documented, with many clinicians deciding research isn’t for them after a single study.
The growth of site networks, with a sole focus on research and the resources to support PIs, has created the ‘career PI’, physicians for whom research is the day job. These PIs have a substantial study counts behind them, some in the hundreds, and a depth of experience from both practice and research that directly benefits sponsors. They can spot the pitfalls in a protocol from a hundred paces. They know where inclusion and exclusion criteria will create friction in the real world, where a procedure window is impractical, and the patient requirements that are likely to drive high dropouts. But that insight only reaches a study if they are looped in at protocol design. When engaged, these investigators can strengthen a protocol before it goes live.
“I came into this field with forty years of clinical perspective. What I’ve found is that medical expertise is genuinely valued by sponsors — the ability to read a protocol and say, in practice, this is how it will work, is a huge help to our partners.” – Dr. Beacham, Medical Director and Principal Investigator, Covington.
Moving Beyond Execution
After career PIs, data maturity is arguably the most immediate expression of how clinical trial delivery is maturing. A network that has run thousands of trials across dozens of therapeutic areas, and done so within a standardized framework, accumulates a depth of pattern recognition that is difficult to replicate. This is where structure matters. Because Velocity owns and operates its sites on a single technology stack, performance data is genuinely comparable across sites, therapeutic areas and study types. An aggregated network can pool data from independent sites, but data pooled from inconsistent systems supports weaker conclusions. For the first time, we can surface trends across the whole operation and identify the factors most highly correlated with performance.
The proliferation of AI tools, and the ability to establish tech teams dedicated to building them, mean networks like Velocity can apply that insight across a range of practical use cases. Our Feasibility Agent, for example, assesses sites against years of longitudinal performance data to produce a ranked list of those most likely to deliver against the specific requirements of a given protocol. Sponsors get better-matched sites, more predictable enrollment, and fewer downstream amendments.
The transactional nature of the traditional sponsor-site relationship means that much of what a modern site network can offer never comes up. Technical capabilities go unrecognized, and data that already exists within site systems, such as cost per patient acquisition, recruitment channel performance, screen failure rates, and operational delivery metrics, is rarely surfaced or requested. Much of it could directly inform how studies are planned, budgeted, and executed, but most sponsors simply don’t know it’s available to ask for.
“A significant portion of site-level capability remains unrecognized and underutilized. Data that could inform how studies are planned, executed, and evaluated already exists within site systems, but is not consistently surfaced or incorporated into decision-making.” – AMRC, What Sponsors Don’t See: The Systems Behind Clinical Trial Delivery
Redefining Strategic Partnerships
Clinical trial delivery is maturing, and the partnership model needs to keep pace. The transactional approach worked when sites were primarily there to execute, but it leaves substantial value on the table now that they can do considerably more.
Velocity has reached a scale where institutional knowledge can stress-test a protocol before it goes live, where feasibility decisions can be grounded in evidence rather than assumption, and where operational insight can shape how a study is budgeted and resourced from the outset. To make the most of that, sponsors need to reconsider what a strategic partnership looks like. Bringing in delivery partners after a protocol is finalized made sense 10 years ago, but the math has changed as much as the players.
Having sat on the CRO side of that relationship for the better part of two decades, I’d argue the industry has been slower to recognize this shift than it should have been. Research delivery has changed faster than the perceptions of its customers, and the sponsors that update their approach will run better studies because of it. If you are designing a protocol now, bring your delivery partner into the conversation before it is finalized. That conversation costs nothing and routinely saves an amendment.
