Redefining project leadership to streamline complex clinical operations and deliver better outcomes

Running a clinical trial is like navigating a storm, tight deadlines, mounting regulations, multiple vendors, and ever-changing protocols. For many biotech companies, these challenges don’t just slow progress, they risk the very success of the trial. What’s missing is not just resources, but the right kind of leadership and structure to steer everything in the right direction.

That’s exactly where Zanteris steps in.

Founded by Mike Failly, Ph.D., a Clinical Operations Consultant with over 14 years of hands-on experience, Zanteris was born from a simple but powerful realization: the way clinical trials are managed needs to change. Too often, companies rely on generic solutions or fragmented teams that lack ownership and direction. Dr. Failly saw the toll this took on trial outcomes, and decided to build something better.

Zanteris brings clarity to clinical chaos by offering tailored consulting services that treat each project as unique. With a sharp focus on early-to-late phase trials, the company combines strategic project management with operational oversight to ensure timelines, budgets, and quality standards stay intact. At the core of this approach is a philosophy Dr. Failly calls “CEO of the Program,” where the project manager takes full accountability, driving collaboration across functions and vendors.

It’s not about doing more. It’s about doing it right.

Zanteris doesn’t just guide trials, they empower clients to regain control, reduce risk, and bring promising treatments to the people who need them, faster and more efficiently than ever before.

The Origin Story

When Mike Failly, Ph.D., launched Zanteris in 2021, he saw something amiss. The clinical operations field was stuck in repetitive routines, projects ran on brute force instead of sharp insight. Mike knew there was a smarter path. “It’s not about working harder. It’s about working smarter.”

Before Zanteris, Mike spent over 15 years driving clinical trials through roles spanning Study Coordinator to Associate Project Director at SYNEOS Health and within pharmaceutical companies. He led cross-functional teams, oversaw vendor performance, and steered complex therapeutic programs. His resume reads like a master course in clinical trial delivery, from oncology to rare diseases .

His epiphany came after witnessing how mass-market outsourcing failed to account for context, culture, and human variables. It wasn’t just about tools, it was about mindset. This realization birthed Zanteris: a consultancy built on customization and deep operational experience, not off-the-shelf solutions.

From day one, Zanteris positioned itself as an extension, not a vendor, blending into clients' teams with minimal overhead. They promised agile intervention, whether in setting up vendor strategies, launching trials, or coaching project managers to think like CEOs of their programs.

That’s the origin: a founder’s informed push for smarter, more tailored support. It didn’t take fluff. The story is disciplined, direct, and built on real-world lessons boiled down to better outcomes.

Strategy in Action: What Zanteris Does Differently

Zanteris is not another CRO. It’s a specialist consultancy focused on clinical operations consulting, project and vendor management, and human efficiency. What this means in the trenches: tight alignment with client goals, risk-aware planning, and leadership-led project delivery.

They step in at the beginning, RFIs, RFPs, vendor selection. They lead bid defense meetings and scope out oversight models. Then they will embed senior consultants to manage budgets, timelines, compliance, and vendors, effectively functioning as your in-house PM to ensure trials stay on target.

It’s a service that spans phases I through IIIb across therapeutic areas from oncology to cardiology. Beyond delivery, they train project leads, “the CEO of the project,” in emotional intelligence, stakeholder communication, and risk management .

The contrast is sharp. Traditional mass-market CROs are process-driven. Zanteris is relationship-driven, risk-savvy, and leadership-first. Not every risk leads to regret. But every regret comes from a risk not taken. This is not marketing fluff, it’s a philosophy steeped in the realities of trial failures and successes .

In short, Zanteris marries operational muscle with strategic finesse. They de-risk trials through active partnership, not checkbox compliance. And they shape client teams to sustain that strength long after contracts end.

Leadership Is the Linchpin

At Zanteris, leadership is not window dressing. It’s the engine. One of their core beliefs: clinicians and scientists deserve project leaders who speak up, go the extra mile, and rally teams, not just manage timelines.

This ethos is reflected in client feedback:

“Goes above and beyond to mentor junior staff… allowing me to grow into an effective leader.”  “We truly view you as part of our family.”

They focus on emotional intelligence, creating open environments where teams raise flags early and innovate together . The goal: clinical project managers who don’t just deliver, they inspire, adapt, and build trust.

Because when trials falter, it's rarely a protocol issue. It’s misaligned communication, hidden cultural tension, or unmanaged risk. "The problem is not the plan. It’s the pressure to follow it perfectly." Zanteris builds leaders who course-correct, not panic when variables shift.

This leadership-driven approach reshapes how teams operate and how sponsors and CROs interact. It reallocates focus: from firefighting to foresight, from compartmentalizing to collaboration.

Tech, AI, and the Human Touch

Even consulting needs to evolve. Mike acknowledges that clinical operations must embrace digital health and AI, but not at the cost of human reasoning. Their mission: to integrate tools thoughtfully, not fetishize them.

From predictive modeling and patient monitoring to digital trial design, Zanteris helps clients test and apply tech-enhanced processes. Yet they temper automation with oversight: AI supports decision-making, but leadership shapes the final call.

They also partner on real-world evidence and remote trial models, anticipating risk and opportunity before issues become critical. It’s fast-moving, but they insist on internalizing capabilities, not just outsourcing them.

What this means day-to-day: their consultants help build digital-savvy, risk-aware frameworks, not turn teams over to tools alone. It’s not about standing back; it’s about hands-on integration.

That balanced stance sets Zanteris apart. They don’t chase tech for novelty. They pick what works for each trial, with clear oversight, training, and deliverables aligned to outcomes, patients first, not tech first.

Looking Forward: Impact and Expansion

Zanteris has already made waves. Featured in The Silicon Review among "Global Best Companies to Watch in 2025," their methodology is gaining traction. LinkedIn buzz shows real-time impact: “First Patient In” posts signal momentum, and client trust growing beyond press releases.

They have carved a niche supporting small to mid-size biotech and life sciences teams, and now they are eyeing a larger market. Scaling without diluting values. More training cohorts. More embedded consultants. Yet their focus remains the same: smart execution, smart leadership, smart outcomes.

Expect deeper moves into digital health, RWE data aggregation, AI-driven risk prediction, and remote operational models. At the same time, anticipate tougher client targets: faster enrollments, tighter budgets, higher oversight pressure, and Zanteris continuing to shift those pressures back into opportunity.

What this really means: Zanteris is not just consulting on trials. They are shaping how trials get done in tomorrow’s industry. They help build internal muscle, create leadership pipelines, and embed tech in ways that respect people, and purpose.

In the end, the metric is not number of consultants, it’s patient impact, trial success, and cultural shift inside sponsors and CROs. And that’s why Zanteris stands apart: they don’t just promise outcomes, they equip teams to own them.

Zanteris is the story of a founder’s experience-driven pivot. It’s a consultancy that turned operational lessons into smarter engagement models. It’s risk-aware, leadership-centered, and tech-savvy, but rooted in human judgment and relationship-building. They mirror Mike’s belief: smart planning and adaptive leadership beat blind execution every time.

That’s the gist. Not fluff. Not just adjectives. A narrative about how one founder reshapes clinical operations from within, and why the industry is taking note.