The CRO Isn’t Failing Your Trial. Your Governance Model Is.

Robert Goldman has run global clinical operations long enough to know what a failing trial looks like before the data readout does. And his diagnosis, shared publicly this week and drawing 208 likes and 66 comments, is not flattering: sponsors who treat a signed work order as a substitute for leadership are the architects of their own trial disasters. “The worst studies had sponsors who thought a signed work order was a substitute for leadership,” Goldman wrote. “No CRO partnership is stronger than the sponsor behind it.” That sentence landed with the force of something the industry has known privately for years but refused to say in print.

The post triggered a convergence. Within hours, two other credible clinical operations voices were publishing their own versions of the same uncomfortable argument. The overlap was not coordinated. That is what makes it significant.

What these practitioners are describing is not a vendor performance problem. It is a governance deficit sitting at the center of an industry that has convinced itself delegation and accountability are the same thing.

The Handoff Illusion

Here is the scenario playing out across small biotech portfolios right now. A sponsor completes a competitive CRO bid process, awards the contract, celebrates the milestone internally, and then progressively reduces its own operational involvement over the following quarter. Weekly calls replace strategic engagement. Status reports replace site-level scrutiny. The CRO says “we’re on track” and the sponsor, lacking the internal expertise to interrogate that claim, accepts it. Six months later, enrollment is behind, the TMF has gaps no one caught in real time, and the root cause review points everywhere except at the governance model that made the failure invisible until it was expensive.

Goldman’s framing cuts through the industry’s polite euphemisms. CROs are hired to extend sponsor capabilities, not to replace sponsor leadership. The moment a sponsor confuses those two functions, the trial is running without a captain.

The deeper problem is structural, and Elena Sinclair identified it with precision: most small biotechs do not fail because the molecule was wrong. They fail because no one sponsor-side was qualified to challenge the trial. That distinction matters enormously for how the industry allocates blame and, more importantly, how it allocates investment in internal capability.

Sinclair cited Tufts CSDD data showing only one in five sponsors rate their oversight processes as highly effective. Read that number carefully. Four out of five sponsors, by their own assessment, are operating oversight processes they do not consider highly effective. Yet the industry continues to treat CRO award as the end of the governance conversation rather than the beginning of it.

The Applied Therapeutics Warning

The regulatory system has already answered the question of where accountability lives when delegation goes wrong. Sinclair’s post surfaces the example the industry should be studying in every clinical operations training: Applied Therapeutics. A vendor deleted 47 patients’ primary endpoint data. The FDA’s warning letter went to Applied Therapeutics, not the CRO. Delegation did not transfer accountability. The sponsor owned the data integrity obligation regardless of which organization’s employees were touching the database.

This is not a novel regulatory position. ICH E6(R2), the GCP guideline governing sponsor responsibilities, is explicit that sponsors retain ultimate responsibility for the quality and integrity of trial data regardless of which tasks have been delegated to a CRO. The FDA’s 2023 guidance on oversight of clinical investigations reinforces the same principle: sponsors must establish and maintain oversight processes sufficient to verify that delegated functions are being performed. The Applied Therapeutics case is what happens when those processes exist on paper and nowhere else.

Sinclair’s diagnostic questions should be read as a protocol for every small biotech board meeting that touches clinical operations. What is your eTMF completeness percentage right now? Who is the CRA at your top-enrolling site, and how experienced are they? When did you last review a monitoring visit report, not just receive it? Did your ClinOps lead design the governance plan, or did the CRO hand it to you? If a sponsor cannot answer those questions in real time, it does not have oversight. Per Sinclair’s post, it has an account relationship.

The efficiency case for CROs is real and should not be dismissed. Sinclair’s post acknowledges that study initiation can be 77 days faster when experienced CROs have established site relationships. Speed and operational capability are legitimate reasons to outsource execution. But execution efficiency without strategic oversight does not produce better trials. It produces faster-moving problems.

The Expertise Gap No One Budgets For

The counterintuitive reality that Goldman and Sinclair are both circling is this: the sponsors most dependent on CRO capability are precisely the sponsors least equipped to oversee it. Small biotechs operating lean, pre-commercial teams frequently lack a single internal employee qualified to evaluate CMP adequacy, interrogate CRO staffing turnover patterns, or conduct a meaningful TMF audit. They hire a CRO because they cannot afford to build the function internally, and then they discover, too late, that overseeing a CRO competently requires nearly the same expertise as running the function yourself.

Goldman’s observation that the best studies he has seen had sponsors deeply engaged in strategy, governance, decision-making, and oversight is not a prescription for redundancy. It is a description of what effective partnership actually requires. The sponsor brings therapeutic knowledge, regulatory strategy, and accountability that no CRO can contractually absorb. The CRO brings operational scale, site networks, and execution infrastructure. Neither half of that equation functions without the other, and the market has spent a decade pretending it can.

Vincent Thompson’s broader framing adds a layer that the operational posts do not address directly: the clinical research ecosystem has achieved extraordinary things through collective commitment, but the question worth asking is whether existing structures can be completed rather than replaced. Applied to the CRO governance crisis, that framing points toward a specific gap. The ecosystem is not broken. The accountability layer connecting sponsor strategy to CRO execution has been left structurally incomplete, and the industry has tolerated that incompleteness because it is expensive to fix and invisible until it catastrophically fails.

The FDA does not inspect a CRO’s intentions. It inspects sponsor oversight. When the only person truly managing a trial sits inside the CRO, the sponsor has not bought execution capacity. It has purchased a very expensive regulatory liability dressed in the language of partnership. Small biotechs without internal ClinOps leadership qualified to own that oversight have one structural option that Sinclair names directly: a fractional Head of Clinical Operations whose job is not to manage the CRO but to prevent the sponsor from pretending oversight exists when it does not.

The governance model is the trial. Every sponsor that has not internalized that reality is one warning letter away from learning it the hard way.

References

1. Robert S. Goldman, LinkedIn post on sponsor vs. CRO leadership roles (2025)
2. Elena (Ella) Sinclair, LinkedIn post on CRO governance failure and Applied Therapeutics (2025)
3. Vincent Thompson MD PhD, LinkedIn post on clinical research ecosystem evolution (2025)