Sniper Shots at Industry Norms
Too Many Stakeholders, Not Enough Accountability: Who Actually Owns the Trial?
The first thing you notice when you step into the war room of clinical trials—the Sponsor's neatly polished boardroom, the CRO's glass-walled command center, the Vendor's bustling project hubs, and the Site's chaotic back offices—is the sheer number of fingerprints on every decision.
A maze of hands stretching across continents and time zones, all grasping at fragments of control.
Each party, supposedly with aligned goals, yet dancing to their own rhythm. But here’s the real question that keeps me up at night and should haunt every professional in this space: Who actually owns the trial?
Is it the Sponsor, who seeds the vision, bankrolls the operation, and signs off on the protocol?
Or the CRO, entrusted with the reins of project management and site engagement?
Perhaps it’s the Vendors, who inject technology and data infrastructure, weaving the digital backbone of the study?
Or maybe it’s the Site, that last mile where protocol meets patient, where the rubber hits the road and the patient’s well-being is truly on the line?
The uncomfortable truth: The more stakeholders we stack up, the murkier ownership becomes.
We have created a labyrinth of accountability, where responsibility is diluted, blurred, and too often—outright evaded.
1. The Great Handoff Culture: Where Responsibility Goes to Die
There’s a phrase that gets tossed around clinical trials like confetti at a parade: handoff. We hand off data, we hand off reports, we hand off patient care. It’s the industry’s well-worn game of hot potato, where no one wants to hold the burden for too long.
The Sponsor designs the study and hands it to the CRO. The CRO builds the project plan and hands it to the Vendor. The Vendor integrates the systems and hands it back to the CRO. The CRO nudges it along to the Site.
Rinse and repeat.
Yet, in all this handing off, accountability becomes like vapor—visible for a moment, then gone. Everyone owns a slice of the pie but no one wants to touch the crust where the real mess lies. So, when the inevitable protocol deviations or enrollment shortfalls emerge, what do we hear?
“That’s a site issue.”
“That’s on the CRO.”
“The vendor didn’t flag that data.”
“The Sponsor delayed the approval.”
The cycle perpetuates, and the trial—the living, breathing patient journey that we claim to care so much about—gets bogged down in this bureaucratic purgatory.
2. Sponsors: The Kings with No Kingdom
Sponsors are supposed to be the captains of the ship. They fund the voyage, map out the course, and rally the crew. But in practice, their command feels more like a figurehead.
The moment they sign that Master Services Agreement (MSA) with a CRO, there’s a tacit understanding: We’ll pay, you execute.
But execution without oversight is a recipe for chaos. While some Sponsors are hands-on—meticulously pouring over monitoring reports and attending every status call—many are happy to ride shotgun, checking in occasionally and rubber-stamping decisions.
Here’s the rub: in their zeal to offload operational headaches, Sponsors often sever the nerve between strategy and execution. Key decisions get diluted through layers of CRO project managers, program directors, and operational leads. The result? When things go south—and they always do—finding the root cause is like unraveling a spider's web in the dark.
3. CROs: Masters of Delegation, Apprentices of Ownership
I once had a conversation with a seasoned CRO Project Manager—let’s call him Mike. He told me flat out: “Our job is not to own the trial, it’s to manage it. There’s a difference, Rudy.”
He was right. The CRO's role is to shepherd the study, moving it from milestone to milestone, ensuring that timelines are met and deliverables are checked off. But here’s the kicker—management is not ownership.
When a study fails to meet enrollment targets, the CRO points to site recruitment struggles. When data quality issues surface, they point to the Vendor. If timelines slip, the blame splashes back to the Sponsor's delayed approvals.
Mike had a list—a literal list—of fallback justifications for when something went wrong:
Site regulatory delays
Data entry backlogs
Sponsor decision bottlenecks
Vendor software glitches
Not once did I hear him say, “We own this.”
4. Vendors: The Silent Middlemen
If you’ve ever worked with an EDC provider or an IWRS vendor, you know the routine. They plug into the trial, build the systems, collect the data, and then disappear behind the firewall.
Their job is critical, but their visibility is deliberately minimal. If something breaks, if randomizations go awry, if data syncing fails, the finger-pointing is immediate.
“We followed the specifications from the CRO.”
“Our system flagged it, but it wasn’t actioned.”
“The integration with the site’s database had a conflict.”
And around we go. The Vendors operate in silos, divorced from the consequences of their technology hiccups.
Their SLAs are iron-clad, their deliverables tightly scoped. Accountability? That’s someone else’s department.
5. Sites: The Boots on the Ground, Left in the Cold
At the bottom of this food chain sit the Sites—the clinics and hospitals where patients actually show up. They are expected to adhere to protocols written by people who have never set foot in their hallways.
They are monitored by CRO representatives who, more often than not, arrive with a checklist rather than a solution.
When deviations happen, the hammer falls hard on the Sites. “Why wasn’t the visit completed within the window?” “Why wasn’t the consent form updated?” “Why did the blood draw happen an hour late?”
But ask a Site Investigator who actually owns the trial—who they go to for real-time answers—and you’ll get a shrug. “We just follow what the monitor tells us.”
The truth is, Sites are the face of the trial to the patient, yet they are the least empowered to influence its direction. They are steered by CROs, scolded by Sponsors, and shackled to Vendor platforms.
6. So, Who Really Owns the Trial?
It’s a question we need to start asking out loud.
In boardrooms.
On project calls.
During site visits.
Ownership needs to be explicit—not implied.
Sponsors need to own the vision and demand transparency.
CROs need to own the execution with unflinching accountability.
Vendors need to own the integrity of their data pipelines and integrations.
Sites need to be empowered, not micromanaged.
Until we shatter this handoff culture and establish clear lines of ownership, we’ll continue stumbling through trials that are far too bloated with stakeholders and far too thin on accountability.
I’m Signing Off:
In an industry where every stakeholder wants to own the success but none want to claim the failure, the patient—who should be at the center of it all—gets lost in the shuffle.
Rudy Malle
Founder, Yana Career Consulting, LLC
Dismantling industry norms, one sniper shot at a time.