Navigating the Pendulum

Through my 25 years inside pharmaceutical clinical operations groups, I’ve seen many different operating models for running clinical trials — each with its own strengths, limitations, and evolving pressures. Now, 7 months into my role as CEO of KPS Life — a company that provides scalable, embedded clinical trial resource solutions across all functions within Clinical Operations — I’ve had the chance to step back and see the full landscape from a new perspective.

It’s helped me better understand the pressures and patterns many companies are navigating.

One of the most enduring patterns in our industry is the pendulum effect. For decades, companies have swung between two extremes — full reliance on outsourcing to Full Service CROs or bringing everything back in-house through dedicated headcount or insourced models. These shifts are rarely the result of long-term strategy; they’re often driven by cost pressures, quality concerns, or internal headcount constraints. And while each swing feels like a correction, it often creates new challenges of its own.

Why does this pendulum exist? Many R&D organizations are facing major budget cuts due to patent cliffs or constrained funding, forcing them to rethink how they outsource and manage cost. At the same time, large CROs are undergoing layoffs and facing pressure to find creative ways to grow in a complex and shifting marketplace. Quality issues are continuing to surface in trial execution, and site relationships — while often discussed — still lack clear, consistent ownership models. Leadership changes can also drive swings, as new executives look to reshape operating models early in their tenure. Many companies seem to be chasing the next fix: bring it all back in-house when CRO performance dips, then shift it all back out again when internal resources run thin. The cycle continues.

The result is twofold — and both come at a cost.

First, organizations often overcommit to a single model, placing all their eggs in one basket without a long-term strategy for flexibility or balance. This can lead to rigid structures that don’t scale with evolving needs. Second, too many great people, with deep expertise and commitment to the science, are being stretched so thin they can’t do their best work.

And that’s a problem — because running clinical trials is one of the most meaningful things we can do in this industry. The purpose is clear: helping patients, advancing science, bringing new medicines to market. But delivering on that purpose requires something simple and scarce: great people who are dedicated, embedded, and empowered to take ownership — to do things right the first time, every time.

I believe the real opportunity isn’t to stop the pendulum — it’s to balance it. While full-service CROs offer scale, they often juggle competing priorities. Purpose-built FSP partners like KPS Life bring singular focus, continuity, and control — essential for Sponsors designing a resilient, balanced model. This approach allows organizations to scale their internal departments with the right mix of ownership, embedded expertise, and external flexibility — without overcorrecting in either direction.

When you find that middle ground, the pendulum stops being a problem. It becomes part of a purposeful model — one that’s built for resilience, not reaction. And ultimately, it helps us do what we’re all here to do: bring new products to patients who need them.

Stepping into this role has only reinforced what I’ve believed all along: clinical trial success starts with the people behind the work. The science may drive the mission — but it’s the people who make it happen.

If KPS Life can support you in designing an operating model that strikes the balance, please reach out to me or Nicole Duffey.