ehind every successful global clinical trial are the people who deliver it, the processes that sustain it, and the precision that defines it. This case study reveals how an international site network worked to sustain operational excellence in a recent osteoporosis study.

Working in site operations within an international clinical research network, I’ve come to understand that operational excellence isn’t just a buzzword: It’s something we live and breathe every day. It’s not just about hitting targets or ticking compliance boxes. It’s about people, processes, and precision—especially in a therapeutic area like osteoporosis, where patient populations are often older, follow-up periods are longer, and endpoints are both clinical and imaging-based. Excellence means maintaining a careful balance between precision, empathy, and efficiency.

Over the past few years, I’ve had the opportunity to work on several global clinical trials, and one of the clearest examples of operational excellence came from our recent participation in a global phase 3 osteoporosis study investigating a new bone-forming therapy for postmenopausal women at high risk of fractures.

What Operational Excellence Means to Us at Site Level

In our site network, operational excellence means being able to consistently recruit the right patients, collect accurate and timely data, comply with protocol requirements, and maintain patient safety, all while staying flexible enough to adapt to local challenges. It also means being able to communicate effectively with both our global partners and our local communities.

For us, it’s the little things that really show we’re doing a great job: how quickly we reply to questions, how carefully we document everything, how rarely we run into challenges with the study protocol, and how well we keep our patients involved. Each of these might seem small on its own; together, they make our work solid and trustworthy.

This particular osteoporosis study involved coordinating regular bone density DEXA (Dual-energy X-ray absorptiometry) scans, managing long-term patient follow-ups, ensuring adherence to calcium and vitamin D supplementation, and working closely with local rheumatologists and primary care providers to identify eligible participants.

Who Defines and Measures Excellence?

Excellence is measured through a set of key performance indicators (KPIs), many of which we monitor daily: enrollment versus target rate, visit compliance and timelines, query resolution time, time from visit to data entry, and patient retention across long follow-up periods.

These metrics (indicators) were outlined by our site network leadership. At the beginning of the trial, we convened a global kickoff meeting where definitions and expectations were clearly laid out to our sites. For example: “Time from site activation to the first screening” was defined as no more than 10 calendar days from the date of patient consent, ensuring that eligible patients were moved efficiently and quickly into the study. “Data entry” needed to be completed within 24 hours of each patient visit. Access to real-time dashboards in our internal systems provided visibility of our performance inside the network.

It’s important to note that while these KPIs were defined for all sites, we encouraged feedback from all sites to refine expectations. For example, we flagged early in the study that elderly participants sometimes required longer visit times, which impacted our average time-to-data-entry metrics.

Real-World Lessons from an Osteoporosis Study

Our involvement in this osteoporosis trial spanned more than a year; even with recruitment limited timelines, we recruited 139 patients across 10 sites in three European countries.

Because osteoporosis is often asymptomatic until a fracture occurs, we had to work creatively to identify at-risk women. We partnered with local clinics and used community outreach events like bone health screenings, mobile diagnostic Osteobuses to educate and recruit patients.

Working in three European countries presented a few hurdles, including translation delays, regulatory differences, and patient hesitancy around newer therapies. However, as a broad international network, we had centralized training and operations support such as consistent training materials, shared technology platforms, and regular updates that helped us stay aligned with the rest of the network.

One operational challenge we encountered was patient retention, because the study required frequent site visits and imaging. We implemented flexible scheduling (extended clinic work hours, weekend appointments, etc.), transportation support, personalized communication (reminder phone calls, patient follow-up plans), and bundled procedures to minimize the total number of patient visits. These solutions were shared with the network and later implemented at other sites facing similar issues. Thanks to constant collaboration with sites, the CRO, and the sponsor, we managed to enroll and retain the proper number of participants in short timelines.

Implementing Change Locally, Sharing Lessons Globally

Commitment to continuous improvement made a big difference, as lessons from one site were shared across the network. For instance, one site developed a patient engagement campaign that improved patient recruitment, and we implemented the same approach in other countries as well. We also participated in regular performance reviews, not as punishment or pressure, but as a way to highlight wins and identify support needs. If a metric dipped, we didn’t get blamed; we got help.

Importantly, these fixes didn’t help only us: They were added to our network’s “best practices” repository and presented during global operations calls so others could benefit. This collaborative learning is one of the best parts of being in an international site network. We didn’t work in isolation. Our network routinely hosted performance reviews and virtual “learning labs” where high-performing sites shared their strategies. This culture of open feedback and continuous improvement made it easier to speak up when something wasn’t working—and to celebrate when it was.

Final Thoughts: Operational Excellence from the Ground Up

Achieving and sustaining operational excellence in a global clinical research site network requires more than checking boxes on a compliance list. It demands a comprehensive strategy involving metric-driven performance, collaborative definition of quality standards, and a robust mechanism for feedback and continuous learning.

Operational excellence at the site level is about owning our piece of the puzzle. It’s about creating strong local processes that fit into a much larger, global system. And it’s about being accountable but also supported, challenged but also empowered.

Our sites learned through this osteoporosis trial that operational excellence isn’t about being perfect: It’s about being consistent, proactive, and responsive. Operational excellence sees every metric not as a scorecard but as an opportunity to learn and improve. When your study deals with a vulnerable population and their long-term outcomes, these values matter even more.

When every site in every network pulls in the same direction, learns from each other, and strives for improvement, we create a system that delivers better research, faster answers, and, ultimately, more hope for the patients who count on us.

To learn more about operational excellence in clinical research, plan to attend our DIA 2025 Global Annual Meeting.