The clinical trials industry has spent the last few years learning some pretty hard lessons about digital transformation. After a decade of pilot programs, proofs-of-concept, and gradual adoption, not to mention the pandemic-driven scramble to decentralize everything, the industry now has a more realistic understanding of what actually works in the real world. Connected devices are no longer an emerging technology but are becoming foundational infrastructure.

This transformation has been driven by converging forces. Regulatory pathways have matured, patient technology has achieved clinical-grade performance, and most importantly perhaps, patients and sites have spoken. They expect seamless, integrated experiences. The industry must rise to the challenge.

What’s Different About 2026?

The projections shared here are observations of trends already in motion, not visionary predictions of some distant future. Some, like the hybrid trial standard, reflect market forces reaching critical mass. Others, such as AI in operations, indicate where early adopters can reap notable rewards. Together, they outline an industry where patient-centricity and operational effectiveness are no longer mutually exclusive goals, but complementary ambitions enabled by thoughtful technology adoption.

The breakthrough devices have been created; the regulatory structures are in place. Now the hurdles are integration, standardization, and scale—translating connected devices from specialized test pieces to infrastructure that sponsors barely notice and sites handle with ease.

Our vantage point—at the intersection of sponsors, sites, patients, and technology vendors—provides unique visibility into what’s working, what isn’t, and where the industry is headed. For strategic leaders conducting clinical trials, clarity about 2026 is essential. The decisions around technology, vendor partnerships, platform investment, and protocol design today will determine tomorrow’s competitive success. The window for reactive tactics is closing.

Crucially, the questions on the minds of clinical trial leaders have now shifted from “Do we adopt connected devices?” to “How do we deploy them effectively at scale?”

Here’s what we’re seeing on the horizon:

The hybrid model becomes standard practice

In 2026, expect the vast majority of new Phase II/III trials to be designed as decentralized or hybrid from day one. Expect to see the majority of new Phase II and III protocols build in both site-based and home-based data collection from the start, rather than trying to bolt on technology later.

And this makes sense when you think about it.

Different endpoints simply need different approaches. Blood draws still need to happen at sites. Continuous glucose monitoring works best at home. The sponsors who figure out how to thoughtfully combine both methods from day one will be the ones who see success quickest. Pure decentralized trials will be limited to specific use cases, not the default modality.

What’s making this possible? Interoperability platforms that actually deliver on their promises. Site coordinators are done juggling dozens of different systems for different trials. If you can’t provide a unified platform in 2026, good luck recruiting sites.

Consumer wearables finally break through

For years, we’ve watched companies like Apple and Samsung dance around the periphery of clinical research without fully engaging in a meaningful way. The reason has always been straightforward: virtually all their revenue comes from consumers, while most of their compliance headaches come from research requirements.

That calculation changes in 2026. We’re predicting at least two major consumer wearable platforms will achieve FDA clearance for primary endpoint collection in specific areas—cardiovascular and sleep disorders are the most likely candidates. The difference now? There’s mature infrastructure that lets these companies keep their consumer and clinical-grade data streams separate while using the same hardware.

This matters more than you might think. When patients can use their own Apple Watch or Galaxy device for a trial, compliance rates shoot up. When technology feels familiar, it fades into the background, and you’re left with just the data, which is exactly what you want. We estimate that patient compliance will increase 30-40% when using familiar consumer devices.

Trials get more complex (in a good way)

Here’s something counterintuitive: as devices get easier to use, trials will incorporate more of them. We’re already seeing studies routinely use three to four different devices, and by the end of 2026, trials using five or more devices will be standard in complex areas like cardiometabolic diseases and neurology.

The trick isn’t minimizing the number of devices—it’s minimizing the cognitive burden. A well-integrated platform can make five or more devices easier to manage than two poorly connected ones. As one site coordinator put it recently: “I don’t care if it’s 10 devices, as long as I only have to log in once.” Unified dashboards will make multiple devices feel like one system, simplifying the experience for both participants and research teams.

This explosion of data streams opens up new possibilities for precision. Instead of just asking whether a drug works, we’ll understand exactly how it works, when it works, and for whom it works best.

AI finds its real role

The AI revolution in clinical trials won’t look like what the vendors are selling you today. While everyone’s talking about AI for data analysis and endpoint detection, the actual impact will be more practical—and more valuable.

In 2026, primary AI adoption will focus on operations rather than data analysis. AI will prove itself in three critical areas: predicting which sites need support before they have to ask for it, automatically flagging potential protocol deviations before they become real problems, and keeping track of regulatory compliance across increasingly complex global requirements. Expect post-Brexit CE mark confusion to worsen before improving as regulatory pathways continue to diverge. China’s unique requirements will drive dedicated technology strategies for sponsors operating in that market.

AI-powered regulatory tracking will become essential for managing the complexity of global trials across multiple jurisdictions. AI won’t be taking over regulatory submissions without human oversight. The FDA has made it clear they want human verification of AI-derived endpoints, and that’s the right call when patient safety is on the line.

Global trials actually become global

This might be the most important prediction for 2026, even if it’s the least flashy: connected devices will finally deliver on the promise of truly worldwide trials. Smaller, faster, cheaper, and more capable devices are changing the economics of global research. A bioelectrical impedance scale that provides near-DEXA quality body composition data can now be deployed to rural sites in emerging markets for a fraction of what it used to cost.

Portable EEG units eliminate the need for patients to travel hundreds of miles to specialized centers. Continuous monitoring devices run reliably for weeks without needing a charge. Remote monitoring will enable rare disease trials in previously unreachable populations, democratizing access to clinical research worldwide.

We’re predicting a 40% increase in trial sites in emerging markets in 2026, driven entirely by what connected devices now make possible. And this isn’t just about saving money—it’s about accessing diverse patient populations that better represent who will use these medications.

Site experience transformation

The problem of using large numbers of laptops will be improved by the end of 2026 as integrated platforms become the norm. Sites may avoid sponsors without integrated platforms, forcing market correction toward user-friendly solutions. Training and support will be embedded directly into device interfaces, reducing the burden on site staff.

The shift from point-in-time to continuous data collection will accelerate significantly. Real-time safety monitoring will become standard instead of a premium feature, while algorithmic endpoints will proliferate for specific therapeutic areas to enable more nuanced and responsive trial designs.

Patient-centricity is paramount

Success will be measured by wear compliance, not just data quality, reflecting a deeper understanding of patient experience. Devices that are more medical in design will be phased out for consumer-friendly designs that participants are comfortable wearing in daily life. Battery life of 5+ days will become the minimum standard, eliminating frequent charging as a barrier to compliance.

What It All Means

These predictions share a common thread: connected devices are moving from exciting possibilities to operational realities. The industry is now focused on figuring out how to deploy connected devices efficiently, reliably, and at scale.

The winners in 2026 won’t be the ones with the flashiest technology. They’ll be the ones who understand that successful trials need technology, services, and human expertise in equal measure. They’ll recognize that making life easier for patients and sites isn’t just a nice-to-have—it’s fundamental to getting quality data.

We remind our teams of this constantly: in clinical research, technology should be invisible. When patients forget they’re wearing a medical device and sites forget they’re using specialized software, that’s when you know you’ve succeeded.

These predictions come from our experience managing connected device trials in over 100 countries and insights from thousands of ongoing studies. The future of clinical research isn’t about picking between traditional and digital methods—it’s about intelligently combining both to generate better evidence, faster.