This article originally appeared as part of The Vendor Edge series on LinkedIn. This is an expanded and updated version for kieranengels.com.
Execution does not break in a single moment. It breaks in the gap between what was planned and what actually happens. Between what the protocol assumed and what sites experience. Between what the contract specified and what the vendor understood. Execution breakdowns are almost always traceable to governance gaps: unclear handoffs, unstated assumptions, distributed accountability where no one actually owns the outcome. The truth is, the majority of clinical trial delays are not rooted in science. They are rooted in the infrastructure of accountability. Kieran Engels and teams across biotech repeatedly observe the same pattern: solid vendors, solid protocols, and yet timelines slip. The common denominator is not vendor quality. It is governance maturity. Organizations that execute well do so because they have invested in clear decision rights, defined ownership, and feedback systems that surface problems early.
KEY TAKEAWAYS
Key Takeaways
- Execution breaks not in single moments but in accumulated gaps between plan and reality, driven by governance failures rather than vendor capability issues.
- Three governance infrastructure elements prevent execution breakdown: explicit decision rights, singular accountability, and early feedback systems.
- Distributed accountability masks true ownership, creating delays that surface only after significant program impact rather than early intervention.
- Clinical trial delays are predominantly rooted in governance maturity, not vendor quality, protocol design, or site engagement.
- Organizations that execute well invest in governance infrastructure before vendor selection and maintain clear oversight systems throughout execution.
The Challenge
Execution does not break at a single point. It accumulates. A protocol detail is interpreted two different ways by the CRO and the site. No one catches it until Week 12. A vendor relationship is governed by contract, but the person responsible for oversight is unclear. Accountability gets distributed. Outcomes don’t improve.
Let’s be clear about what we mean by execution. Execution is the space between strategy and outcome. Between what the protocol specifies and what happens at the site visit. Between what the vendor promised and what they delivered. This is where clinical trials either hold together or begin to fray.
The breaks almost always follow the same pattern. Someone assumes another person understood the requirement. A handoff happens without explicit confirmation. Accountability exists on paper but not in practice. The vendor operates under one set of assumptions. The sponsor operates under another. The site operates under a third.
Kieran Engels has observed this across dozens of programs. The vendors involved are competent. The protocols are sound. The sites are engaged. Yet execution gaps emerge. When these gaps are investigated, they trace back to governance infrastructure, not capability.
Governance infrastructure means several things working together. First, decision rights are explicit. Who decides when? Who decides what? These questions have clear answers before the program starts, not during firefighting. Second, accountability is singular. Not shared. Not distributed. A person owns each outcome, and that ownership is public within the team. Third, feedback surfaces problems early. Not at the end of the quarter. Not at the audit. When a vendor misses an expectation, the sponsor knows within days, not months.
The Infrastructure
The organizations that execute well invest in this infrastructure. They spend time defining governance before they spend time managing vendors. They ask: Who is accountable for site activation? Who is accountable for monitoring? Who is accountable for vendor performance? And they make sure the answer to each question is a person, not a committee.
What separates execution that holds from execution that breaks is not vendor selection. It is governance selection. And governance is a choice. It is something an organization builds.
Seuss+ has worked with biotech leadership teams that faced recurring execution delays. The first assumption is always vendor capability. The second instinct is to find better vendors. But when governance gaps are mapped, the pattern becomes clear. Handoffs are unclear. Feedback is delayed. Accountability is distributed. These are not vendor problems. These are governance problems.
The fix is not better vendors. The fix is better governance infrastructure. Clear decision rights. Singular accountability. Early feedback. And an investment in the systems that keep these in place during the inevitable chaos of a clinical program.
This is not about finding perfect vendors or perfect plans. It is about building the oversight systems that allow good vendors to execute good plans.
Common Execution Breakpoints
| Where It Breaks | What It Looks Like | Root Cause | Governance Fix |
| Protocol Interpretation | CRO interprets requirement one way, site implements another. Gap discovered Week 12. | Unclear handoff between sponsor, CRO, and site | Explicit written sign-off from all parties at protocol briefing |
| Vendor Accountability | Vendor misses timeline. Responsibility unclear between account manager and operations. | Distributed accountability within vendor team | Single named owner per vendor deliverable, with escalation path |
| Risk Escalation | Issue identified but not escalated until monthly meeting | No early feedback mechanism | Daily standup or weekly sync with defined escalation triggers |
| Decision Authority | Three people could approve vendor invoice. No one does until finance demands action. | Distributed decision rights | Single approver named at program kickoff |
| Monitoring Gaps | Monitoring plan exists but no one is assigned to execute it | Accountability exists on paper but not assigned to a person | Named monitoring coordinator with weekly feedback to sponsor |
The truth is, execution breaks not in a single moment but in the gap between what was planned and what actually happens.
Key Industry Data
The cost to replace a specialized clinical operations professional ranges from 100% to 200% of their annual salary, making vendor team stability a financial imperative. (Source: Industry benchmarks)
Between 50% and 60% of clinical trial activities are outsourced, making vendor ecosystem design a core operational competency. (Source: IQVIA)
CRO market consolidation is accelerating, with major acquisitions in 2025 and 2026 reshaping vendor landscape options. (Source: Clinical Leader)
The global CRO market is projected to grow from $79.5 billion in 2023 to over $125 billion by 2030. (Source: Grand View Research)
63% of all new clinical trial starts now come from emerging biotech companies that depend heavily on external vendor ecosystems. (Source: IQVIA)
Frequently Asked Questions
Vendor capability addresses what is delivered, not how it is delivered or how it is overseen. Execution breaks when accountability is unclear, feedback is delayed, or decision rights are distributed. A competent vendor operating in a governance vacuum will still miss deadlines and create unexpected costs. The vendor is not the problem. The governance infrastructure is.
It means one person owns each outcome. Not a committee. Not a shared responsibility. One person is named responsible for vendor performance, one for site activation, one for monitoring. That person is not hiding behind a committee. They are visible. They are escalating early. They are solving problems before they become delays.
Problems should be visible within days, not weeks. This means governance infrastructure includes a daily or weekly feedback mechanism. A standby call. A shared dashboard. A named escalation path. When a vendor misses a deliverable, the sponsor should know within a few days, not at the monthly business review when it is too late to adjust the program.
No. Science is unpredictable. Sites face unexpected challenges. But governance infrastructure prevents the delays that are entirely preventable: those caused by miscommunication, distributed accountability, and delayed feedback. A strong governance system catches problems early and allows the team to adapt rather than firefighting at the end.
Define decision rights and accountability before the program starts. Not after the first delay. Before. Sponsor leadership should explicitly answer: Who decides what? Who is accountable for what? Who escalates problems to whom? These questions should be written down and reviewed with the full team at kickoff.
About the Author
Kieran Engels is CEO and Co-Founder of Seuss+, a strategy and execution partner helping biotech sponsors optimize vendor relationships across clinical development. With more than a decade of experience in vendor governance, risk management, and clinical trial execution, Kieran works with biotech leadership teams to build the oversight systems that protect timelines, budgets, and data integrity. Learn more at seuss.plus.
