Clinical catfishing is what happens when a vendor’s proposal does not match their operational reality. The proposal promises a team, a timeline, and a methodology. Execution reveals different staff, different timelines, and different capability. This is not always malicious. It is often a systemic problem: the team that writes the proposal is not the team that executes the work. The incentive structure rewards winning bids, not honest capability assessment. A vendor can promise excellence in the proposal because the proposal team has no accountability for execution. The execution team operates under different constraints. Kieran Engels has observed this pattern across CROs, sites, and specialized vendors. A proposal names a medical director with 15 years of experience. Execution reveals that the medical director will be reviewing work but the day-to-day team is junior and less experienced. This is not deception. This is misalignment between proposal and execution incentives.

KEY TAKEAWAYS

The Challenge

The problem with clinical vendor selection is misaligned incentives. The person writing the proposal is incentivized to win the bid. The person executing the work is incentivized to deliver profitably. These are not the same person. They often do not even know each other.

A CRO receives an RFP. The business development team responds. The proposal promises a monitoring plan with monthly on-site visits, a dedicated program manager, and a quality review cadence of twice weekly. The sponsor reads this and feels confident about execution oversight.

Then execution begins. The program manager assigned is junior and divided across three programs. Monthly on-site visits become quarterly because travel budgets are tight. Quality reviews are weekly, not twice weekly. The vendor is not breaking their contract. They are operating within its letter but not its spirit. The difference between what was proposed and what is executing is real.

This is not the vendor lying. This is the vendor operating under different constraints than what the proposal assumed.

Let’s be clear about what is happening. The proposal team is rewarded for closing deals. The execution team is rewarded for managing costs. These incentives are misaligned. And the gap between them is where execution problems emerge.

Kieran Engels has seen this across different vendor types. A CRO proposes a team with specific people. During execution, one of the named people leaves for another job. They are replaced with someone less experienced. The CRO fulfilled the contract by providing a replacement. But the execution capability decreased.

A site proposes a patient population and enrollment timeline. During execution, the patient population is harder to recruit than expected. Enrollment slows. The site did not breach the contract. They are operating in a harder environment than what the proposal assumed.

A specialized vendor proposes a novel analysis approach. During execution, the approach proves more complex than anticipated. Timelines slip. The vendor is doing the work they promised. But the delivery is delayed.

These are not vendor failures. These are proposal-execution gaps. And they are endemic to how vendor selection works.

The Infrastructure

The RFP-proposal process assumes that what is written in the proposal will be executed. But proposals are written by the people who sell. Execution is done by the people who deliver. These are different incentives operating on different timelines.

How does a sponsor address this? First, involve the execution team in the selection process. Not the business development team. The team that will actually do the work. This creates alignment. The people writing the proposal are the people who will execute it. Their incentives are the same.

Second, require specific staffing commitments. Not generic promises about a “dedicated team.” Specific names. Specific roles. Specific hours. And contractual protections if the named person is reassigned without cause.

Third, build feedback mechanisms that surface proposal-execution gaps early. A governance infrastructure with weekly feedback means that if the execution team is delivering differently than what was proposed, this becomes visible within weeks, not months.

Fourth, build governance infrastructure that clarifies expectations before execution starts. A proposal that promises a monthly on-site visit plan should result in a written monitoring plan that details which months, which sites, which activities. This forces specificity before the contract is signed.

Seuss+ works with biotech leadership navigating vendor relationships that have proposal-execution gaps. The first response is often to escalate to the vendor relationship manager. The vendor’s response is often technically accurate. But it does not close the gap between what was proposed and what is executing.

The real solution is systemic. Align the incentives of the proposal team and the execution team. Require specificity in proposals. Involve execution teams in selection. Build feedback mechanisms early.

This is the work of buying with your eyes open. It requires acknowledging that proposals are aspirations, not commitments. And commitments require specificity, accountability, and governance infrastructure to enforce.

Proposal vs. Reality

Key Industry Data

70% of clinical trials experience delays, with more than half related to site activation. (Source: Tufts CSDD)

Nearly 80% of trials fail to meet their original on time enrollment targets. (Source: Tufts CSDD)

Cancer center median trial activation time is 167 days, compared to the NCI target of 90 days. (Source: AACI/NCI)

Daily trial delays cost sponsors between $600,000 and $8 million per day in lost revenue opportunity. (Source: Tufts CSDD)

Best performing clinical facilities achieve 5% to 10% operating cost improvements through clinical standardization and productivity gains. (Source: McKinsey)

Frequently Asked Questions

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.

The post Clinical Catfish appeared first on Kieran Engels.

AI-generated RFPs and proposals are becoming common. They sound polished. They are structurally complete. And they are often fundamentally misleading. When a vendor uses AI to respond to an RFP, the sponsor receives answers that are technically correct but operationally empty. The polish masks whether the vendor actually understands the program. The truth is, AI is a tool for efficiency. But vendor selection requires human judgment, specificity, and the ability to detect when a vendor is telling you what you want to hear rather than what is true. Kieran Engels has observed proposals generated by AI that hit every requirement on the RFP yet offered no specific insight into how the vendor would actually execute the work. The proposals looked complete. They were complete. They just were not true. This is not a criticism of AI. It is a recognition that tools are inputs, not authority. AI can make a proposal polished. Only people can make a proposal honest.

KEY TAKEAWAYS

The Challenge

AI-generated proposals are becoming standard practice in vendor selection. A vendor receives an RFP. They feed it into an AI system. The system generates a response that addresses every requirement, uses professional language, and is internally consistent. The sponsor reads it and sees a vendor that understands their program.

But here is what is actually happening. The AI system is reading the RFP and generating text that mirrors the structure of the RFP back to you. It is not generating insight. It is generating reflection.

Let’s be clear about what this means operationally. An RFP asks: How will you manage monitoring in a decentralized trial? The AI-generated response says: We will implement a comprehensive monitoring strategy that leverages remote tools to ensure data quality while minimizing site burden. This is technically correct. It is also operationally empty. It does not say what tools, how often, what happens when something goes wrong, or what this will cost.

A human-generated response from someone who has actually managed monitoring in decentralized trials would say something different. It would say: We manage decentralized monitoring through three touchpoints. First, real-time EDC review with alerts for out-of-range values, flagged within 24 hours of entry. Second, weekly video monitoring calls with sites, focused on high-risk data points. Third, monthly on-site visits to a subset of sites, rotating based on enrollment and data quality trends. This approach costs more than central monitoring but catches problems early.

The difference is specificity. Specificity requires experience. Specificity requires judgment. Specificity is what you need to evaluate whether the vendor can actually execute.

AI-generated proposals optimize for surface-level correctness. They address every requirement. They use language that mirrors the sponsor’s values. They show up on time. But they hide the operational reality beneath a layer of polish.

Kieran Engels has seen this pattern repeatedly. A vendor submits a proposal that sounds excellent. It covers all the bases. The sponsor moves forward. Execution begins. The vendor’s actual approach is different from what the proposal suggested. The monitoring plan is less frequent. The team is different. The escalation path is not what was promised. The vendor is not lying. They are implementing a different approach than what they proposed. But by the time this becomes clear, the vendor has been selected and implementation has started.

This is a selection problem, not a vendor problem. The selection process failed to distinguish between AI-generated polish and operational truth.

The Infrastructure

How does a sponsor address this? Several approaches work. First, ask for specificity. When a vendor proposes a monitoring strategy, ask them to name the monitoring coordinator, describe their experience, and outline the monitoring visit calendar by program month. Specificity is hard to fake. AI-generated proposals dodge specificity.

Second, ask about constraints. Every operational approach has constraints. A monitoring strategy that promises weekly visits has cost implications. It requires staffing. It requires logistical coordination. A vendor that does not acknowledge constraints is hiding from operational reality.

Third, involve the team that will do the work in the selection process. The person who will actually manage monitoring should meet the vendor’s proposed monitoring team. Not the vendor’s business development person. The actual monitoring team. This is uncomfortable for vendors. It is also revealing. This is where operational truth becomes visible.

Fourth, require references that check operational capability, not just vendor viability. Ask references: Did the vendor deliver what they proposed? Were there surprises? What would you do differently? References often reveal gaps between proposal and reality.

Tools are inputs, not authority. AI is a tool. It can make a proposal efficient. It can make a proposal polished. But only human judgment can make a proposal honest.

Seuss+ works with biotech leadership teams navigating vendor selection in an AI-abundant environment. The risk is not that AI will generate false statements. The risk is that AI will generate technically correct but operationally empty statements that obscure whether the vendor actually knows how to execute.

The solution is not to ban AI. The solution is to change the selection process. Make proposals more specific. Require constraint acknowledgment. Involve execution teams. Check references on operational capability.

This is the work of buying with your eyes open. It requires more work than reading polished proposals. But it prevents the expensive surprise of discovering after selection that the vendor’s proposal did not match their operational reality.

AI-Generated vs. Human-Generated RFP Responses

Key Industry Data

The FDA conducted 6,375 domestic researcher inspections between 2007 and 2015, with 360 resulting in significant violations and 194 triggering regulatory actions. (Source: FDA)

FDA warning letters increased 59% year over year, from 190 in FY2024 to 303 in FY2025. (Source: FDA)

The most common FDA inspection violations include failing to maintain accurate case histories (10.82%), enrolling ineligible subjects (8.85%), and failing to perform required tests (8.52%). (Source: FDA warning letter analysis)

Responses to FDA Form 483 observations are due within 15 business days. (Source: FDA)

Only 5% of FY2025 warning letters concerned clinical research or IRB oversight, indicating that when violations occur in clinical settings, they are treated with heightened severity. (Source: FDA)

Frequently Asked Questions

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.

The post When AI Writes the RFP appeared first on Kieran Engels.

Executional strength is not hiring better people or finding better vendors. It is building systems that allow good people and good vendors to perform. Many biotech organizations assume execution is a function of talent. Hire the best director. Bring in the most experienced CRO. Partner with the leading site network. Yet execution still stalls. The gap between talent and outcome is infrastructure. Kieran Engels works with leadership teams that have recruited exceptional people and partnered with respected vendors, yet timelines slip and costs overrun. The difference between organizations that execute well and those that don’t is not the talent at the table. It is the systems that structure how that talent works together. Executional strength means clear decision rights, defined accountability, regular feedback, and governance systems that surface problems early. These systems can be built. They are not mysterious. But they require intentional investment.

KEY TAKEAWAYS

The Challenge

The assumption in biotech is that execution is a talent problem. If you hire the right person, execution improves. If you find the right vendor, execution follows. But this misses the core issue. Talent and vendors are inputs. Systems are infrastructure.

Executional strength is what happens when systems allow inputs to perform. When decision rights are clear, talent does not waste time negotiating authority. When accountability is singular, vendors know exactly what they are responsible for and what escalation looks like. When feedback is regular, problems surface before they compound.

Let’s be clear. The organizations that execute well are not the ones with more talented people. They are the ones with more mature governance infrastructure.

Kieran Engels has worked with teams that included exceptional people. Directors with 15 years of experience. Vendors with pristine track records. Yet execution was inconsistent. When governance infrastructure was mapped, the pattern became clear. The talented people were spending energy on clarification, negotiation, and firefighting rather than on execution. The infrastructure was not in place to let talent work.

What changed? Not the people. The systems.

A clear example: decision authority. When is a decision made? By whom? Who has the final say? In immature organizations, this is ambiguous. A vendor wants to make a change. The sponsor leadership is unclear who has authority to approve. Debate happens. Time passes. The vendor waits. The timeline slips. This is not a talent problem. It is an infrastructure problem. The answer is a single decision matrix that says: this type of decision is made by this person, with this approval timeline, and here is how dissent is handled.

The Infrastructure

Another example: feedback cadence. How often does the vendor report? How often does the sponsor review? How often does escalation happen? In immature organizations, feedback is annual or quarterly. Problems fester. By the time they surface, they are expensive to fix. In mature organizations, feedback is weekly or daily. Problems are visible early. Adjustments can be made while they are still small.

The third example: accountability clarity. When something goes wrong, who is accountable? In immature organizations, accountability is distributed. The CRO says the sponsor should have been clearer. The sponsor says the CRO should have been more proactive. The site says they were following the protocol. No one owns the outcome. In mature organizations, accountability is singular. A person owns each outcome. That person is named. That person escalates early if they are at risk of missing the outcome.

These are not new concepts. They are not mysterious. They are infrastructure. And infrastructure is a choice. An organization either builds it or does not.

Seuss+ has worked with biotech leadership that faced persistent execution challenges. The first instinct is always to change vendors or change people. Sometimes that is necessary. But in most cases, the first work is governance. Define decision rights. Name accountability. Establish feedback cadence. Map escalation paths. Then execute.

What this requires from leadership is discipline. It is easier to assume a person or vendor is the problem. It is harder to admit that the organization does not have clear governance infrastructure. But organizations that make this admission and invest in building infrastructure see immediate improvement in execution consistency.

This is the work of building execution capacity. It is not about finding better vendors. It is about building the systems that let good vendors execute.

Executional Strength Assessment

Key Industry Data

Phase II clinical trials average 75 protocol deviations, affecting nearly one third of enrolled patients. (Source: TransCelerate BioPharma)

Phase III trials average 119 protocol deviations per study, with oncology trials showing deviation rates affecting more than 40% of patients. (Source: TransCelerate BioPharma)

Electronic source data capture reduces protocol deviation rates by 54% compared to paper based systems. (Source: ACRP)

Organizations investing in structured quality training programs have achieved up to 194% improvement in cost avoidance. (Source: Healthcare quality benchmarks)

A single quality improvement initiative saved one health system $3.2 million in avoided penalties after training over 10,000 team members. (Source: Quality training ROI analysis)

Frequently Asked Questions

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.

The post Building Executional Strength in Clinical Development appeared first on Kieran Engels.

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

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

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

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.

The post Where Clinical Trial Execution Actually Breaks appeared first on Kieran Engels.

Strategy without execution accountability is theatre. Biotechs and VCs focus on scientific strategy and capital allocation but consistently underweight execution infrastructure. The companies that succeed in clinical development are not the ones with the best science. They are the ones with the clearest governance, the strongest vendor oversight, and the most honest assessment of their execution capability. Execution is not downstream of strategy. It IS strategy. The difference between biotech companies that get drugs to market on time and budget and ones that spiral is not science. It’s execution discipline.

KEY TAKEAWAYS

The pitch is always the same. Brilliant science. Clear pathway to IND. Strong management team. Compelling market need. VCs hear it and fund it. Then somewhere between kickoff and first-in-human, things get complicated.

Understanding the Fundamentals

The science is still good. But timelines are slipping. Vendors are missing deliverables. There’s confusion about who’s accountable for what. Leadership is in constant firefighting mode. The company is burning through capital faster than anyone projected, not because the science failed but because the execution infrastructure wasn’t built to support the strategy.

This is what Kieran Engels sees repeatedly: Biotech teams and their investors have a strategy problem that looks like an execution problem. The real problem is that execution was never treated as strategy.

The Real Cost of Misalignment

Here’s the truth. The difference between a biotech company that gets a drug to the clinic on timeline and budget and one that spirals is not the quality of the science. It’s the clarity of the governance. It’s whether there’s a real feedback loop between what’s happening in execution and what the leadership team knows. It’s whether vendors understand what they’re supposed to deliver or just think they do.

Biotech companies and their investors spend months refining scientific strategy. They run market analyses. They model capital allocation. They debate the molecular basis of the disease. And then they treat execution like a checklist item. They assume that good people with a good science will somehow automatically execute well.

Building Governance Infrastructure

That assumption is wrong. Good science requires good execution infrastructure. Without it, the science never reaches the market. The science doesn’t fail. The timeline fails. The budget fails. The vendor relationships fail.

Let’s be clear about what execution strategy actually includes. It’s not just timelines and budgets. It’s vendor governance. Which vendors can actually deliver what you need? How will you know if they’re delivering it? What’s your decision-making structure? How will you catch problems early? If these questions aren’t answered before you start, you’re not executing strategy. You’re hoping.

The Speed Advantage

Seuss+ works with biotech teams to build execution strategy that actually supports scientific strategy. It’s not about adding overhead. It’s about preventing the hidden costs that come from vendor misalignment, scope drift, and leadership distraction.

One of the biggest mistakes biotech teams make is underestimating the cost of poor vendor management. They see vendor costs as a percentage of budget. But when a vendor misaligns with what you need and doesn’t deliver on time, the cost compounds. It’s not just the vendor cost. It’s the delay to your IND timeline. It’s the capital burn while you’re waiting. It’s the opportunity cost of the market window closing. Poor vendor management can destroy the financial model of a biotech company.

The other mistake is treating execution as a problem to be solved with more management. More project managers. More status meetings. More reports. That’s not execution strategy. That’s overhead. Execution strategy is clarity. Clear governance. Clear decision rights. Clear accountability. When those things are in place, a smaller team executes better than a larger team without them.

This is also why VCs should care about execution strategy as much as scientific strategy. A company with good science and bad execution infrastructure will fail. A company with good science and clear execution infrastructure will get the drug to the market on timeline and budget. The difference is not in the science. It’s in the infrastructure.

Kieran Engels has worked with biotech teams that had weak execution infrastructure and tried to compensate by hiring more people. It doesn’t work. You just hire more people in a dysfunctional system. What works is fixing the system. Getting clear on decision rights. Getting clear on vendor accountability. Getting honest about execution capability and building infrastructure around that.

The companies that move fastest are not the ones with the biggest teams. They’re the ones with the clearest governance. They’re the ones where the vendor understands exactly what they’re supposed to deliver. They’re the ones where leadership has visibility into execution without constant escalations. They’re the ones that catch problems early because there’s a feedback structure in place.

Speed without execution infrastructure is just panic in a different disguise. Speed with clear governance, strong vendor oversight, and honest assessment of capability is real acceleration. That’s the difference between biotech companies that succeed and ones that don’t.

Strategy-Only Approach vs. Execution-Integrated Approach

Key Industry Data

Trial delays cost sponsors $600,000 to $8 million per day in lost revenue opportunity. (Source: Tufts CSDD)

FDA issued 303 warning letters in FY2025, a 59% increase from 190 in FY2024. (Source: FDA)

The FDA formally adopted ICH E6(R3) on September 9, 2025, shifting the regulatory standard from routine monitoring to risk based, proportionate oversight. (Source: FDA)

Per patient costs in clinical trials range from $113,000 to $136,000 depending on therapeutic area and phase. (Source: IQVIA)

Clinical trials cost between $4 million for Phase I and over $100 million for Phase III programs. (Source: Industry benchmarks)

Frequently Asked Questions

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.

The post Why Execution Is the Real Strategy, What Biotechs and VCs Keep Getting Wrong appeared first on Kieran Engels.

Poor governance creates hidden costs that bleed across clinical programs. Scope drift accumulates silently. Financial leakage happens in budget gaps and contract overages nobody tracks. Rework multiplies in handoff failures and unclear ownership. Leadership fatigue sets in when decisions are questioned and re-made. Delivery slows because priorities shift without clear rationale. Governance breaks at four distinct levels: the board sets strategy but misses execution reality; executives make decisions without full vendor context; operations clash with vendor capabilities; vendors operate without clear accountability. The fix requires governance as a design system: clarity in strategy, explicit priorities, documented assumptions, and agreed conditions before execution begins.

Key Takeaways

Understanding the Four Levels of Governance Breakdown

Governance failures rarely announce themselves. They accumulate in quiet ways. A board approves a vendor selection based on operational assumptions that turn out to be wrong. Executives make decisions about trial timelines without consulting the vendors who will execute them. Operations teams implement processes that vendors cannot support. Vendors operate without clear accountability for decisions they influence.

Each level breaks independently. When all four break together, the result is a program that runs slower, costs more, and delivers less than promised.

Four Levels of Governance Breakdown

The Cost of Silent Scope Drift

Scope drift happens in the gaps between intent and execution. A vendor delivers more than contracted because nobody said no. A trial expands in scope because the decision to expand happened in a meeting without formal approval. Budget shifts because assumptions about effort were never documented. The accumulated effect is a program that costs 20% more and takes 20% longer than planned, but nobody can point to a single decision that caused it.

Building Governance into Strategy

The fix is not more meetings or more approvals. The fix is clarity. Kieran Engels works with sponsors to define strategy with operational precision. What are we building? What are we not building? What are we assuming about vendor capability? What happens if those assumptions break?

Seuss+ helps teams document these decisions and create governance systems that prevent them from being silently eroded. Decision criteria become explicit. Approval pathways become clear. Accountability becomes assigned.

Key Industry Data

The global CRO market reached $79.5 billion in 2023, with the top five players controlling more than 35% of market share. (Source: Grand View Research, IQVIA)

63% of new trial starts now come from emerging biotech companies that often lack internal infrastructure to evaluate CRO capability. (Source: IQVIA)

Between 50% and 60% of all clinical trial activities are outsourced to CROs globally, making selection the single highest impact operational decision. (Source: IQVIA)

A single protocol amendment adds approximately three months and $500,000 or more in unbudgeted costs, often driven by misalignment between sponsor expectations and CRO delivery models. (Source: Tufts CSDD)

Daily trial delays cost sponsors $600,000 to $8 million per day, and mid trial CRO transitions compound those losses significantly. (Source: Tufts CSDD)

Frequently Asked Questions

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.

The post The Hidden Cost of Poor Governance appeared first on Kieran Engels.

Sponsors routinely underinvest in governance because governance looks like overhead. It feels like bureaucracy. The real cost is downstream: scope drift, vendor misalignment, rework, leadership time consumed by decisions that should have been resolved upstream. Every dollar not spent on governance clarity at the beginning generates multiples in hidden cost downstream. This is the pennywise-pound-foolish problem of clinical development. Governance is not bureaucracy. It is the system that prevents waste.

KEY TAKEAWAYS

The conversation happens in almost every sponsor organization. Finance is pushing back on oversight costs. Someone says, “Do we really need this level of governance?” Someone else says, “That feels like overhead. Let’s strip it back and move faster.”

Understanding the Fundamentals

And then eight months into the program, the timeline has slipped. Scope has drifted. The vendor is saying the requirements were unclear. The team is in constant firefighting mode. And the cost overrun is three times what the governance investment would have been.

This is the pennywise-pound-foolish problem of clinical development. Sponsors underinvest in the clarity that prevents problems and then spend multiples managing the problems they could have prevented.

The Real Cost of Misalignment

Let’s be clear about what governance actually is. Governance is not bureaucracy. Governance is the system that prevents the cascade of small misalignments that become big problems. It’s decision rights. It’s clear KPIs. It’s change management. It’s a feedback cadence that lets you catch misalignment early instead of discovering it after months of execution.

The cost of poor governance is not visible. That’s why it gets underfunded. A governance failure doesn’t show up as a line item. It shows up as scope creep. It shows up as a vendor saying they didn’t understand what you needed. It shows up as a timeline extension that wasn’t planned. It shows up as leadership time spent on decisions that should have been resolved upstream.

Building Governance Infrastructure

At Seuss+, Kieran Engels has modeled the hidden cost of governance underinvestment. Sponsors with weak governance structures typically experience 10 to 30 percent scope drift over the course of a clinical development program. That’s not because the science changes. It’s because decision-making authority was never clear. So decisions get made, unmade, and remade as different stakeholders weigh in at different times.

Governance underinvestment also generates vendor misalignment costs. A vendor that wasn’t given clear requirements upfront will misinterpret what they’re supposed to deliver. That misinterpretation doesn’t get caught until they’re already three months into execution. Then you spend six weeks negotiating what was actually supposed to happen. Then they have to rework it. That’s months of delay and cost that could have been prevented by investing in clarity at the kickoff.

The Speed Advantage

The other hidden cost is leadership time. Sponsors with weak governance structures have escalations coming up constantly. A decision needs to be made and no one is clear on who should make it. So it goes to the sponsor’s leadership. A vendor is pushing back on a requirement and no one is clear on what the requirement actually is. So it becomes a leadership conversation. These escalations consume hundreds of hours per year. They distract from strategy. They slow down everything else.

Governance clarity in four areas prevents most of this cascade. Decision rights. Who actually decides things? What decision authority does the sponsor’s leadership have? What authority does the vendor have? What happens if you disagree? If that’s not clear, you’ll spend months discovering it through conflict.

KPI definition. What does success look like? What are you actually measuring? What is the vendor accountable for? If that’s not defined before execution starts, you’ll spend the whole program arguing about whether the vendor is delivering or not.

Change management. How do you handle scope change? Who approves it? What’s the process? If that’s not clear, every change request becomes a negotiation. Scope drift accelerates.

Accountability structure. What’s the feedback cadence? How often do you review performance? What happens if something isn’t on track? If that’s not in place, problems don’t surface until they’re disasters.

Investing in these four things upfront costs time and focus. It’s weeks of conversations with stakeholders about what they actually need and what authority they’re comfortable delegating. It’s negotiation with the vendor about what they’re accountable for. It’s not fast.

But it prevents the alternative. The sponsors who move fastest in clinical development are the ones who got the governance clarity done first. They move faster downstream because decisions are already made. Expectations are aligned. Problems get caught early because there’s a feedback structure in place. Vendors are clear on what they’re accountable for so they deliver on it rather than discovering misalignment months later.

Kieran Engels has seen sponsors try to skip the governance work and move fast. They all end up slower downstream. The governance work doesn’t compress. It just gets moved from the planning phase to the crisis management phase. And in the crisis management phase, it’s more expensive and more costly.

This is also why governance is not a luxury for well-resourced sponsors. It’s a necessity for fast execution. The sponsors with the least budget can least afford to have scope drift, vendor misalignment, and leadership overhead consuming their timeline. They’re the ones who need governance the most.

Governance Investment vs. Downstream Cost Impact

Key Industry Data

70% of clinical trials experience delays, with more than half related to site activation challenges in multi-country programs. (Source: Tufts CSDD)

The EU Clinical Trials Regulation mandates assessment timelines of 50 to 81 days from submission to decision. (Source: EMA)

North America now accounts for only 27% of global trial starts, while Asia accounts for 30%. (Source: Citeline/Statista, 2021)

The Asia Pacific region contributed more than 50% of the 70,000 new clinical trials registered between 2017 and 2021. (Source: Citeline)

Over 452,000 clinical trials are registered globally, with nearly 65,000 actively recruiting as of 2023. (Source: WHO Clinical Trials Observatory)

Frequently Asked Questions

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.

The post Governance Underinvestment,  The Pennywise Problem in Clinical Development appeared first on Kieran Engels.

KEY TAKEAWAYS

Here’s what most vendors know: Clinical sponsors are looking for vendors that feel right. Polished. Available. Responsive. So vendors optimize for that. They build great decks. They make themselves available for endless discovery calls. They promise flexibility and adaptability.

Understanding the Fundamentals

And then execution starts. The resource that was going to lead your project gets pulled onto something else. The timeline they approved starts shifting because no one was clear on what ‘done’ looked like. The governance structure you agreed to in kickoff never quite takes shape because no one defined what the sponsor’s decision rights actually are.

The problem wasn’t the vendor. The problem was that you were evaluating fit based on signals that don’t matter.

The Real Cost of Misalignment

Operational proof is different. It’s asking: How does this vendor actually work? What are their real constraints? How do they staff projects? What happens when we ask them something that contradicts something else in their proposal?

Let me be clear. The vendors that fail in clinical development aren’t failing because they lack capability. They’re failing because there’s misalignment between what the sponsor needs and what the vendor can realistically deliver. That misalignment is visible in the proposal and in how they respond to constraints. Most sponsors just don’t know how to read it.

Building Governance Infrastructure

At Seuss+, the work is helping sponsors see the governance signals in vendor proposals. A vendor that can clearly articulate their staffing model is more trustworthy than a vendor that promises unlimited flexibility. A vendor that tells you their constraints is more reliable than a vendor that says they can do anything. A vendor whose proposal is internally consistent is more aligned with your needs than a vendor whose proposal shifts depending on the conversation.

This is governance-led vendor evaluation. You’re not asking, “Do we like working with them?” You’re asking, “Is their operational model aligned with how we govern? Can we clearly define what they’re supposed to deliver? Can we hold them accountable for it?”

The Speed Advantage

The vendors that succeed in clinical development are the ones where there’s no surprises in the governance structure. You ask them about their decision cadence, and it matches what you need. You ask them how they handle scope change, and their answer aligns with your change management process. You ask them about continuity, and their staffing model supports it.

Kieran Engels has worked with dozens of sponsors who hired vendors based on best-fit feeling and then spent months in rework and negotiation. Every single time, the signs were in the proposal. The vendor was promising something that contradicted something else. Or they were being vague about staffing. Or their timeline assumed a decision-making pace that didn’t match how the sponsor actually operates.

The other vendors, the ones that deliver on time and on scope, are usually not the most impressive in the pitch room. They’re the ones who asked the most questions about your governance. They’re the ones who said no to things that didn’t fit their model. They’re the ones who were explicit about their constraints.

This is also why vendor failure isn’t really vendor failure. It’s governance failure. If you hired a vendor based on a feeling rather than operational alignment, and they fail to deliver, that’s not because they’re incapable. It’s because you didn’t diagnose what they could actually deliver before you signed.

Governance-led vendor evaluation prevents that. It forces both sponsor and vendor to get clarity on expectations before execution. It creates accountability because the expectations are explicit. And it prevents the months of misalignment and rework that come from discovering too late that the vendor’s operational model doesn’t match your governance needs.

Traditional Vendor Selection Criteria vs. Governance-Led Criteria

Key Industry Data

Daily trial delays cost sponsors between $600,000 and $8 million per day in lost revenue opportunity. (Source: Tufts CSDD)

63% of all new trial starts now come from emerging biotech companies, up from 56% in 2019. (Source: IQVIA)

The top five CRO companies hold more than 35% of total market share. (Source: IQVIA)

Between 50% and 60% of all clinical trial activities are now outsourced to CROs globally. (Source: IQVIA)

The global CRO market reached $79.5 billion in 2023 and is projected to exceed $125 billion by 2030. (Source: Grand View Research)

Frequently Asked Questions

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.

The post Why Best-Fit Vendor Is Dead, And What to Look for Instead appeared first on Kieran Engels.

This article originally appeared as part of The Vendor Edge series on LinkedIn. This is an expanded and updated version for kieranengels.com.

Risk is not something to eliminate. It’s a diagnostic tool. Most clinical development teams respond to risk by building more controls, adding more oversight, and pushing the problem downstream. The teams that actually move fast are the ones who read risk signals early, understand what they mean about governance and vendor readiness, and use that information to make better decisions upstream. When risk is treated as information rather than threat, it becomes one of the most powerful steering tools in a sponsor’s toolkit.

KEY TAKEAWAYS

Let’s be clear about what risk actually is. Risk in clinical development isn’t inherent danger. It’s information. It tells you something about the clarity of your governance, the readiness of your vendors, and the alignment between what you’re asking people to do and what they understand they’re supposed to deliver.

Understanding the Fundamentals

The problem is how sponsors respond to that information. Most clinical development leaders see a risk signal and treat it like a threat. They build another control. They add another approval gate. They escalate the decision. The risk doesn’t go away. It just gets buried deeper, waits longer, and explodes bigger downstream.

Kieran Engels and the team at Seuss+ have spent the last decade watching this pattern repeat. Teams that move fast in clinical development aren’t the ones with the most controls. They’re the ones with the clearest upstream governance. They read risk early, diagnose what it means, and use that diagnosis to reframe the problem.

The Real Cost of Misalignment

Here’s the cognitive shift: Risk is not a problem to solve. It’s a signal to read. When a vendor proposal contradicts itself, that’s not a vendor problem. That’s a governance problem. It means your requirements weren’t clear enough for them to hit. When a timeline is beginning to slip, that’s not a capacity problem. That’s an alignment problem. It means someone isn’t clear on priorities.

The teams that actually succeed understand the difference. They use risk as a diagnostic tool. They ask: What does this signal tell us about clarity, alignment, and readiness? What was supposed to happen that didn’t? What’s the upstream cause?

Building Governance Infrastructure

This isn’t about lower risk. This is about faster decision-making. When you can read risk signals and translate them into specific governance changes, you solve problems before they become crises. You prevent the months of rework that come from discovering misalignment after execution has already begun.

Governance-informed risk reading also changes how you evaluate vendors. Vendor risk is not about whether they’re capable. It’s about whether there’s alignment between what you need and what they actually deliver. A vendor might be technically excellent but structurally misaligned with your decision-making cadence. That’s a risk signal. It tells you something needs to change in how you’re partnering with them.

The Speed Advantage

The truth is that Kieran Engels has watched sponsors spend millions on additional vendor oversight because they couldn’t read the upstream risk signals. The additional controls don’t fix the problem. They slow everything down. What fixes it is going back to the beginning and asking: What was supposed to be clear that wasn’t? What alignment is missing?

This is why governance isn’t overhead. Governance is the system that lets you read risk signals early and respond before they cascade. Every hour you spend getting clear on roles, decision rights, and expectations upstream is an hour that prevents three hours of rework, escalation, and crisis management downstream.

Risk-informed governance also changes how you manage speed. Speed without visibility is panic. Speed with clear governance and honest risk reading is acceleration. The difference is whether you can see the problems coming.

Risk Signals vs. Typical Response vs. Governance-Informed Response

Key Industry Data

An estimated $20 billion in annual R&D spending is wasted due to poor clinical trial management and preventable failures. (Source: Clinical Trials Transformation Initiative)

A single protocol amendment in a Phase III trial adds approximately three months and over $500,000 in unbudgeted direct costs. (Source: Tufts CSDD)

Nearly 60% of all trial protocols require at least one amendment, with one third of those amendments being avoidable. (Source: Tufts CSDD)

39% of Phase III small molecule trials fail to progress to a regulatory application. (Source: Tufts CSDD)

Only 11.8% of drugs entering clinical testing ultimately gain regulatory approval. (Source: Tufts CSDD)

Frequently Asked Questions

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.

The post Risk as a Powerful Tool in Clinical Development appeared first on Kieran Engels.

KEY TAKEAWAYS

The False Binary That Breaks Teams

Leadership teams often believe they must choose. Be empathetic and risk unclear accountability. Or be accountable and risk appearing harsh. This binary is false. It persists because organizations have historically distorted both concepts. Accountability got weaponized into blame. Empathy got reduced to conflict avoidance. Kieran Engels has seen this dynamic destroy vendor relationships within weeks. A team that lacks empathy becomes a team that does not listen. A team that lacks accountability becomes a team with unclear expectations. The result: mutual frustration and escalating conflict.

The truth is: empathy is the precondition for clear accountability. If a vendor does not believe you understand their constraints, they will interpret accountability conversations as punishment. If they do not see empathy, they default to defensive postures. Similarly, if you are empathetic but never clarify what accountability looks like, you are being kind in the moment and cruel later, when misaligned expectations unravel the relationship.

What Empathy Really Means in Governance

Empathy in governance is not softness. It is clarity about context. It is understanding that your vendor has constraints you may not see. They have competing priorities from other clients. They have resource limitations. They have knowledge gaps about your program. Empathy means articulating these constraints explicitly so neither party misinterprets the other. It means asking why before assuming incompetence. It means understanding that when a vendor misses a deadline, the explanation matters because it informs how you course-correct.

Seuss+ builds governance that starts with empathy. Before you set expectations, understand what your vendor is working with. Before you hold them accountable, make sure you have given them the information they need to succeed. Before you escalate a miss, understand whether it is a capability gap or a resource allocation problem. These are not soft conversations. They are clear and direct. They prevent misinterpretation. They build trust.

What Accountability Really Means in Practice

Accountability is not punishment. It is clarity about consequences. It is defining upfront what will happen if expectations are not met. It is measuring progress against those expectations. It is giving feedback when performance drifts. It is following through when adjustments are needed. Accountability becomes harsh only when it arrives as a surprise. When it is expected and consistent, it is experienced as fair.

The core problem with many governance structures is distributed accountability. “We all own this.” “It is on all of us.” These statements sound collaborative and empathetic. They are actually the death of accountability. When everyone is accountable, no one is. When a program misses a milestone, unclear accountability means unclear corrective action. Vendors experience this as arbitrary. Sponsors experience this as evasion. Redesign accountability to be clear and specific. This vendor owns this deliverable. This sponsor leader owns this decision. This timeline is non-negotiable unless jointly agreed otherwise.

Three Scenarios: What Happens When You Get the Balance Right

Consider a scenario where a CRO misses an enrollment milestone. Without empathy, the response is punitive: escalate, audit, threaten replacement. The vendor becomes defensive. Collaboration ends. Enrollment actually slows because the vendor is protecting itself. With empathy alone, the response is understanding: “We get it, enrollment is hard. No worries. Let us adjust the timeline.” Expectations fade. The vendor has no incentive to course-correct. Timeline keeps slipping.

Now consider the third path: empathy and accountability working together. The conversation is direct but human. “We understand you are experiencing site recruitment challenges. That changes our view of the root cause but not our accountability expectation. We will adjust timeline by two weeks based on your revised recruitment plan. If that plan misses, we need to discuss replacement options. But we want to solve this together first.” The vendor is heard. But expectations are clear. This conversation is harder than either extreme. It is also the only one that builds sustainable relationships.

Three Approaches to Governance: Comparison

Key Industry Data

Retention improves measurably in organizations that invest in customized onboarding, mentorship programs, and inclusive leadership development. (Source: Industry retention analysis)

Senior executive turnover costs 213% of the departing leader’s annual salary when accounting for recruitment, onboarding, lost productivity, and institutional knowledge gaps. (Source: Leadership development research)

The cost to replace a specialized pharmaceutical or biotech professional ranges from 100% to 200% of annual salary, with senior roles exceeding $500,000 per replacement. (Source: Talent management research)

CRO voluntary separation rates have historically run at 12.5%, compared to a national average of 1.5% across industries. (Source: Industry benchmarks)

Pharmaceutical sales sector average annual turnover is 35%, with 44% of sales representatives leaving within their first two years. (Source: PharmExec)

Frequently Asked Questions

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.

The post Empathy and Accountability Are Not a Trade-Off: Building Governance That Works appeared first on Kieran Engels.