Stop Outsourcing Your Brain: Why Sponsors Should Architect Their Own Proof-of-Concept Trials

A case from the patient’s chair on how “turnkey” becomes a strategic black box.

Maya didn’t join the trial for the biomarker.

She joined because she wanted to be able to walk her son to school without stopping halfway to catch her breath.

On her first visit, she signed a stack of paperwork, answered the same medical history questions three different ways, and left with a diary app she was told to complete daily. She did it every night because she believed it mattered. Because she mattered.

By week six, Maya felt something shift. Not dramatic. Not miraculous. But real: fewer bad mornings, less fatigue, more “normal” days in a row.

At the next visit, she tried to explain it. The coordinator smiled politely and pointed her back to the schedule: blood draw, ECG, vitals, questionnaires, out the door.

The trial’s primary endpoint wasn’t designed to capture what Maya was feeling.

And that, more than the budget, more than the CRO contract, more than the dashboards, was the moment the trial was decided.

Because in proof-of-concept, you don’t get many shots to find signal. And patients don’t get their time back.

The sponsor thought they bought speed. They bought a black box.

Six months earlier, Maya’s trial looked like a clean, rational decision.

A midsize pharma company had promising early data and a narrow internal window to prove the program’s value before the next portfolio decision. Leadership wanted to get into clinic fast and reduce coordination overhead. A full-service CRO offered a reassuring pitch: turnkey delivery, “proven templates,” one vendor to manage, fewer headaches.

So the sponsor signed a full-service proof-of-concept (POC) contract in the “big number” range many teams recognize, millions to low tens of millions, because it sounded like certainty.

Instead, they got distance from the most important work: thinking.

And in POC, outsourcing the thinking doesn’t just risk inefficiency. It risks missing the truth.

Case: What went wrong (and how the patient felt it first)

1) Protocol design drifted from hypothesis to template

The sponsor had a specific scientific hypothesis about how the therapy should work in the real world. But full-service protocols often begin with what’s scalable and familiar, not what’s surgically aligned to your mechanism and your earliest signal. This misalignment can turn even a well-planned clinical trial into a blunt tool rather than a signal detector.

So the trial architecture quietly became “standard.”

From Maya’s seat, the visits were heavy and repetitive, but the measures felt detached from her lived experience. She showed up, followed the rules, did the work. The trial simply was not listening in the right language that reflected her reality.

From the sponsor’s seat, the endpoints looked defensible on paper, but they were blunt tools for a nuanced effect. Only later did the team realize the study had been design for operational ease, not scientific precision.

POC isn’t about building the Phase III machine.

 It’s about building a signal detector.

2) Site selection optimized for convenience, not cohort truth

Full-service CRO networks can be valuable until network convenience becomes the strategy.

Sites get chosen because they are available and known, not because they are best aligned to your target population, disease subtype realities, or recruitment channels. Enrollment slows, screen fails climb, and the cohort starts to drift.

From Maya’s seat, the site was two hours away. Visits meant time off work, childcare juggling, and a quiet fear every time she wondered, Is this even worth it?

Burden creates dropout.

Dropout creates missingness.

Missingness creates noise.

Noise kills signal.

3) Data interpretation became a report, not a living instrument

In a full-service model, updates often follow the vendor's schedule rather than the pace of scientific discovery. Analysts may be smart, but if they aren’t embedded in the hypothesis, the story gets flattened.

Sponsors end up reverse-engineering their own clinical trial long after the critical moments have passed.

From Maya’s seat, she kept filling out the diary. No one ever asked about it. No one ever followed up on her trend.

From the sponsor’s seat, the first serious “insight” arrived as a slide deck weeks later. This was after opportunities to adapt had already slipped by.

POC trials should behave like living experiments, not quarterly business reviews.

The uncomfortable truth: full-service POC often buys infrastructure you don’t need

When sponsors bundle everything from planning through closeout, early-stage studies can end up carrying Phase III-level weight:

• layers of project management

• heavy vendor coordination

• overbuilt processes

• high FTE billing on low-complexity work

That bloat doesn’t just increase spend. It can reduce signal quality by slowing decisions and limiting adaptive moves.

In POC, the goal is clarity, not complexity.

And every extra layer between sponsor and signal is risk.

The turning point: what the midsize pharma company changed

The company didn’t struggle because CROs are bad. They struggled because they delegated decisions that are non-delegable.

The pivot was simple but uncomfortable. They stopped treating POC like outsourced execution and started treating it like sponsor-led architecture.

They kept the operational brain in-house and brought in modular partners only where execution muscle created real lift.

What becomes non-delegable in sponsor-led POC

If you want the patient’s reality and your mechanism to meet in the data, the sponsor must own:

Hybrid modular execution: keep your brain and gain muscle

This is where hybrid modular models win: sponsors keep strategic control while plugging in specialized execution partners as needed, recruitment, data capture, monitoring, analytics, without swallowing the full-service overhead.

Rubix LS is built around this approach, co-building trial architectures with sponsor teams so the protocol stays hypothesis-led, patient-aligned, and decision-ready, while modular execution support can be added where it truly accelerates the work.

The point isn’t to do everything yourself.

 It is to keep the thinking close to the science and close to the patient.

Because the patient is where your signal lives.

The real cost of outsourcing your brain isn’t just money

It is Maya’s diary entries that never become insight.

It is a cohort that doesn’t reflect the population you’ll ultimately need to serve.

It is a trial that ends with: “We didn’t see enough,” when the truth is, you didn’t build the detector.

Full-service overkill belongs to yesterday’s playbook. The future of POC is lean, strategic, patient-aligned, and sponsor-led.

If you want to see the numbers behind why an overbuilt full-service POC can be the wrong investment for early and mid-stage teams, and what a leaner architecture can look like in practice, the next article breaks it down.

If you found this helpful, stay tuned for the next post.