Clinical Operations Doesn’t Need More Tools. It Needs Better Design.

Cambridge, MA — February 17, 2026 - By: Urszula Bartlomiejska, Director, Clinical Operations —
Friction in Clinical Trials: Where It Happens

I left SCOPE Summit 2026 with an observation that’s been building for years and is now hard to ignore: we’re not short on technology, we’re short on execution design in clinical research and clinical trial management.

Across the industry, from biopharma and biotechnology companies to full-service CRO partners, we have platforms, portals, remote visit capability, AI pilots, and dashboards that can generate more signals than any team can realistically action. And yet, study after study, the same dynamics apply from Phase I through Phase IIIB: timelines stretch, sites absorb more administrative load, and patients fall out when participation stops fitting into real life.

What felt different at SCOPE wasn’t a new technology promise. It was how often conversation moved past “what’s available” and straight into “what’s workable” in real-world clinical trial management.

Clinical trials rarely fail loudly. They fail quietly through friction. Friction looks like a patient who wants to participate but can’t reconcile travel, time off work, childcare, and upfront expenses. It looks like a coordinator spending more time logging into systems than supporting participants. It looks like three people from one trial are emailing the site with the same questions while the site tries to figure out who actually owns the decision.

That isn’t a technology problem. It’s an operating model problem. And the industry is saying it out loud.

Patient-Centered Design in Action

Patient-centred trials are also starting to mean something operational, not just aspirational. The phrase has been around long enough to blur into the background. But this year, people weren’t only repeating it; they were describing how they’re redesigning the experience so patients can actually complete the journey.

 

I heard some practical examples of patient solutions and decentralized clinical trials (DCT) approaches that remove friction: making pediatric participation less intimidating through child-friendly explanations (sometimes using a toy that mirrors medical procedures), removing the reimbursement bottleneck by shifting from “submit receipts and wait” to concierge-style travel and expense support, and designing hybrid visits that reduce disruption without reducing oversight, like a nurse at the patient’s home while the investigator joins remotely in real time.

 

Site Overload and Operational Constraints

None of these is a silver bullet. The point is the shift underneath them: experience is being treated as an operational variable, not a marketing statement. Because experience drives enrollment. Experience drives retention. Experience drives quality.

The next constraint isn’t recruitment. It’s sites. If there was one theme I heard in every track of the conference, it was this: sites are overloaded. Not “busy”. Overloaded. I heard “another password” more times than I heard “innovation.”

The industry has unintentionally designed a world where a site can run multiple studies using the “same” platform and still be forced into separate logins, workflows, rules, and points of contact. That’s not modernization. That’s multiplication. And when issues arise, the site too often doesn’t know who owns the resolution because ownership is split across functions, partners, and layers of oversight.

This is where better site management, site and patient solutions, and clearer clinical project management models become critical. This is how cycle time gets lost: not in the plan, but in the handoffs.

Digital Transformation vs Cycle Time

Digital transformation is underway, but the cycle time story hasn’t followed. We are clearly moving from paper to digital, from digital to remote, and from remote to AI-supported workflows. That evolution is real. But one of the more honest undercurrents I heard was that, despite all this transformation, molecule-to-market timelines are not shorter.

That’s the part leaders in clinical research organizations (CROs) and biopharma teams need to sit with. Technology is an amplifier. If the process is heavy, it amplifies heaviness. If the process is clean, it amplifies speed.

Turning Signals into Action

If we want the cycle time to move, the hard work remains the same: simplify protocols and data burdens, reduce duplication, clarify ownership, and build decision systems that translate signals into action. That includes stronger regulatory support, data management, and biostatistics alignment across teams.

Monitoring is a good example of this tension. Centralized monitoring and RBQM are no longer emerging; they’re becoming the expectation in expert clinical trial management. The logic is sound: fewer routine on-site verification activities, and more targeted oversight driven by risk and signals. But signals don’t make decisions. Organizations can generate flags all day long; what matters is whether they have clear thresholds, ownership, escalation paths, and a decision loop that changes behaviour fast enough to matter.

Redesigning Execution for Operational Excellence

That’s where operational maturity shows not in the framework, but in the strength of action.

So, if you lead clinical operations, the most important question in 2026 isn’t “What tools should we adopt?” It’s: what should we stop doing that creates friction, and what redesign of execution will make trials simpler for patients and sites? The organizations that win won’t be the ones with the most technology. They’ll be the ones that make participation easier, sites more effective, and decisions faster and clearer.

That’s what operational excellence looks like now.

About Stiris Research

Stiris Research is an entrepreneurial Clinical Trial Management company specializing in conducting complex Phase I through IIIB trials for North American biotechnology and biopharmaceutical companies. Stiris Research was formed as a result of listening to the stakeholders engaged in clinical trials, identifying their unmet needs, and developing a unique, value-based approach to address those needs.

For more information, please contact:

Marketing – Stiris Research Inc.

Email: info@stirisresearch.com

www.stirisresearch.com