Never Underestimate The Power Of Clinical Operations
By Suzanne Vyvoda, fractional COO/CDO and clinical operations strategist
In the race to bring therapies to patients, biotech teams are moving faster than ever. Early milestones — like protocol development and CRO selection — signal momentum. But buried beneath the urgency to launch is a quiet assumption that can derail even the most promising programs: If we have a protocol and a CRO, we’re ready to go.
That assumption is costing teams time, budget, trust, and progress.
Clinical operations isn’t just a task force for running the trial, it’s the strategic arm that turns intent into impact. It’s how science becomes care. And when it’s missing or underpowered, the ripple effects are felt at every stage of execution.
Too often, clinical operations is treated as a transactional or downstream function. Once the protocol is drafted and a CRO is selected, there’s a sense that the operational heavy lifting is covered. But ask anyone who’s worked through an enrollment stall, a budget blowout, or a protocol amendment mid-study, and they’ll tell you execution isn’t plug and play. And even the best CROs can’t solve foundational gaps in design, oversight, or vendor integration without sponsor-side leadership.
At its worst, this mindset creates a false sense of security. Leaders assume that once the “trial engine” is turned on, it will keep running smoothly. But trials don’t fail because the CRO didn’t try hard enough. They fail when protocols can’t be executed, when vendors work in silos, when sites don’t feel supported, and when operational plans are reactive instead of proactive.
I once worked with a biotech that onboarded their clinical operations lead only after protocol finalization and CRO contracting. The logic was simple: “We’ll bring someone in to run the trial once the pieces are in place.” But within weeks of FPI, the gaps were clear. The protocol was elegant on paper but unworkable for sites. Eligibility criteria were too restrictive, and patient visit schedules were too intense. Sites began pushing back, enrollment was delayed, and the CRO escalated a flurry of site concerns. What followed was three months of protocol revisions, site reengagement, and a complete reset of timelines. None of it was necessary, had clinical operations been involved from the start.
The consequences of underestimating clinical operations are rarely theoretical. They show up as protocol amendments that should have been feasibility checks, as fractured vendor relationships due to misaligned expectations, as enrollment bottlenecks that drain both morale and budget, or as trial teams working in permanent reaction mode, constantly firefighting issues that were avoidable with earlier, deeper strategic planning.
So, what does clinical operations actually do? In short: everything that transforms a protocol into a functioning, patient-centered trial.
Clinical operations pressure-tests feasibility, not just in theory, but in practice. Can sites recruit these patients? Will patients actually enroll and stay on study? What are the hidden burdens in the visit schedule, the data flow, and the logistics? Clinical operations identifies these issues before they go live — before the cost of change becomes steep.
It builds and manages vendor ecosystems that align with the complexity of the study, not just the sponsor’s Rolodex. This includes selecting, onboarding, and overseeing CROs, labs, technology providers, specialty vendors, and more. It doesn’t just monitor vendor KPIs — it creates the environment where vendors can succeed and be held accountable.
Clinical operations also serves as the integrator across clinical development. It connects regulatory, medical, data management, biostatistics, and quality, ensuring cross-functional inputs are reflected in operational plans, timelines, and risk mitigation strategies. In lean teams, where headcount is limited and functions are stretched thin, clinical operations often becomes the glue: filling gaps, anticipating needs, and holding execution together.
And at the executive level, clinical operations plays a vital — yet often invisible — role in strategic decision-making. It informs how realistic timelines are communicated to investors. It validates whether portfolio prioritization reflects operational capacity, not just scientific potential. It equips CEOs, COOs, and boards with visibility into trial execution risk and enables them to act early.
A well-structured clinical operations team can be the difference between smooth interim data delivery and a scramble that erodes stakeholder confidence. It connects the dots between operational metrics and capital runway, allowing leadership to tell a credible, data-backed story to both internal and external stakeholders.
Crucially, clinical operations centers the site and patient experience. Strong clinical operations considers not just what is scientifically sound, but what is operationally realistic and human-centered. How long will the IRB review really take for this protocol? What will site coordinators struggle with? What logistics will trip up patients or caregivers? These aren’t small details. They are the difference between a trial that exists on paper and one that succeeds in the real world.
Let’s walk through a simple comparison.
Company A brings clinical operations in early, during protocol drafting. They engage sites and patient advocates during design, incorporate input into feasibility assessments, and build a vendor plan tailored to the study’s risk profile. They create tools, timelines, and clear expectations for execution partners. When the trial launches, the team can focus on enrollment and engagement — not cleanup.
Company B waits until the protocol is finalized, the CRO is selected, and contracts are signed. When clinical operations joins, they inherit decisions they didn’t help make. Sites are frustrated with the protocol’s complexity. The CRO is confused about timelines. Amendments are already in motion. And leadership is left asking why things aren’t moving faster.
Same CRO. Same study budget. Very different outcomes.
What sets them apart isn’t the CRO’s effort, it’s the sponsor-side engine guiding execution. That engine is clinical operations.
In another recent example, a biotech sponsor was heading into a high-stakes pivotal study with confidence, but little operational grounding. The protocol was aggressive, timelines ambitious, and vendor contracts already in place. Clinical operations flagged several disconnects in patient pathway assumptions and helped restructure visit schedules that would have otherwise violated local standard-of-care norms. They engaged sites proactively, revised country-by-country assumptions, and built in scenario modeling for enrollment projections. The result? First patient in ahead of schedule, zero major protocol deviations in the first three months, and sites reporting high satisfaction. That’s not luck. That’s strategy meeting execution.
This isn’t just relevant for large organizations with robust infrastructure. In early-stage and resource-constrained biotechs, clinical operations may be one person. But the right person — empowered and engaged early — can make the difference between momentum and mayhem. When teams are lean, clinical operations becomes the project manager, the vendor wrangler, the protocol analyst, the risk mitigator, and the internal communicator all at once. Without it, other functions are left to fill the gaps without the right context or experience, and things inevitably slip.
The biotech space is filled with incredible science, brilliant founders, and mission-driven teams. But translating that science into successful trials requires more than intent. It requires infrastructure, strategy, and clarity. And execution that starts well before FPI.
Clinical operations isn’t a glorified project manager or a CRO babysitter. It’s not a team you hand things off to after the “real work” is done. It’s the link between your scientific goals and the patients you hope to serve.
Without it, even the best protocols stall. With it, teams move forward with confidence, consistency, and care.
If you’re building or rebuilding your clinical operations function, don’t make it an afterthought. Bring it in early, empower it fully, and treat it like what it truly is: the operational strategy that powers your science.
About The Author
Suzanne Vyvoda is a biotech executive and clinical trial strategist with over 20 years of experience leading global development programs across oncology, immunology, inflammation, and rare disease. She has worked across large pharma and emerging biotechs, including roles at Gilead, AbbVie, and Telavant (a Roivant company), and has since held executive and consulting positions in high-growth startups. Suzanne specializes in clinical operations, vendor oversight, and cross-functional execution, partnering with early-stage teams to build the people, plans, and infrastructure that move therapies from pipeline to patients. She is passionate about breaking down silos across clinical research to drive smarter, faster, and more collaborative development.