Across clinical research, VivoSense has seen sponsors make meaningful investments in wearable sensors and digital measures, often led by forward-looking innovation teams working to bring new kinds of evidence into clinical development that address unmet needs. These efforts frequently generate promising signals and valuable data. However, when digital measures are introduced without the full scientific, operational, analytical, and evidence strategy needed to advance their usage in clinical development, even encouraging results can be difficult to translate into clear actionable next steps. In those moments, organizations may struggle to sustain momentum, and teams can be reorganized before the field has fully captured what was learned.

Kyle Busacker, who leads growth strategy at VivoSense, sees this as an opportunity to strengthen the learning loop for the field. While sensors are an important part of the equation, the greatest value comes from the process around them. “The process is the magic ingredient,” Busacker said. VivoSense’s perspective is that digital measures succeed when the technology is supported by intentional partnership across study design, operations, analysis, and evidence planning. This ensures early investments do not end with isolated signals but contribute to a scalable strategy for decision-grade evidence.

What a Wearable Sensor CRO does

VivoSense has worked on wearable sensors and digital measures in clinical research since 2010, and it grew up around scientists who studied this work formally rather than technologists who discovered sensors and went looking for a use. After its 2022 Series A, the company spent close to two years working out how to categorize itself to best push digital measures forward. In response, VivoSense pioneered the Wearable Sensor CRO model, a flexible but comprehensive solution designed to seamlessly support the full lifecycle of wearable sensor implementation in clinical research. 

The Wearable Sensor CRO model was deliberate on two levels. The first is descriptive. A contract research organization exists to absorb the operational burden of clinical research so sponsors can focus on the science, and VivoSense applies that logic specifically to wearable sensors. Rather than sell a measure for a sponsor to implement and hope it works, or ship hardware to a site and leave the value to chance, the Wearable Sensor CRO runs the full service of designing the digital measure strategy, getting the sensors to the sites,  onto the patients and the data into its platform, and doing the specialized analysis that turns complex signals into something a regulator and a patient can understand. The second reason is practical. Sponsors already have a procurement category for CROs, so the name fits a category their sourcing teams know how to buy, clearing a path through the institutional machinery that often stalls anything labeled experimental or exploratory.

Busacker frames the value of this model as risk reduction across the three pain points where sponsors most often lose ground. On design, a common failure is reaching for an off-the-shelf measure and hoping it fits the unique population and indication. In terms of operations, the investment breaks down when it recovers only half the data because half the patients were not wearing the device. On analysis, it is handing a biostatistics team a volume and type of data it has never worked with and expecting clean answers. Each is a place where investment quietly evaporates, and VivoSense’s role is to absorb the burden and ensure value across all three. 

As Chief Scientific Officer Kate Lyden put it, sponsors often understand the complexity at one stage of a trial but not across the whole of it, and the most expensive mistake is not a bad sensor choice, but the absence of a clear purpose, plan, and expertise for the data before the study even begins.

The case for doing the work early

If the VivoSense team returns to one piece of guidance most often, it is to create opportunities for learning before a digital measure is placed into a high-stakes decision pathway. Jen Blankenship, a senior research scientist at VivoSense who works with sponsors on study design, sees early-phase work as one of the most valuable ways to strengthen a digital measure strategy and determine whether a measure is fit for purpose. Early studies give teams room to evaluate whether patients and study teams can use the technology successfully, whether data collection is feasible, whether the analysis produces interpretable results, and whether the measure captures something meaningful for the trial.

For sponsors moving quickly toward pivotal trials, the pressure to preserve time and budget is real. But early-phase implementation can create value well before a digital measure is ready to support an efficacy claim. Used thoughtfully, exploratory digital measures can sharpen decisions between phases, while teams still have room to act on what the data reveal. They can help sponsors understand whether a therapy is showing meaningful promise, where more evidence is needed, and how best to invest in the next stage. “That maybe is not as sexy,” Blankenship said, “but it’s helpful.” The return on that early investment is twofold: better decisions now, and a stronger evidence strategy for the studies that follow.

Why a competitor-friendly investment makes sense

This is where VivoSense’s sponsorship of the Library of Digital Endpoints becomes the point. 

The Library is a free, openly available reference cataloging digital endpoints used in industry-sponsored trials across therapeutic areas, created so the field can build on what has already been done instead of starting from zero. The honest question is why a for-profit company would fund a resource its competitors can use, and Lyden’s answer goes to how she believes the field advances. 

Competition drives innovation in digital measurement, but in a field this new, the whole ecosystem benefits from shared learning. Sponsors, technology partners, researchers, and regulators are still working through how to use digital measures well: how to generate meaningful evidence, improve trial efficiency, better capture outcomes that matter to patients, and build the evidence packages needed for confident decision-making. Precompetitive collaboration helps the field learn faster from what work, what does not, and how these measures are being implemented in clinical trials. That is what the Library aggregates. By helping the field move in the same direction now, shared resources like the Library can accelerate progress toward a future where digital measures are a trusted part of clinical development, creating value for patients, sponsors, and the broader clinical research community.

The Library is a powerful snapshot of a specific slice of the field. It catalogs digital endpoints used in industry-sponsored trials that evaluate the safety or efficacy of an FDA-regulated product. It keeps growing as more endpoints earn their way into those trials. Sponsors are the forcing function, the ones who can invest, design well, and move endpoints up the hierarchy from exploratory to secondary to primary, and the Library is where that work becomes visible and reusable.

What better looks like

The narrative that needs to shift is the idea that a pivotal Phase 3 trial with a digital primary endpoint is the only outcome worth celebrating. That milestone matters, but treating it as the sole measure of success overlooks the value digital measures are already delivering across clinical development: informing endpoint selection, strengthening evidence strategies, supporting internal decisions, and helping sponsors better understand how treatments are impacting outcomes that matter to patients. The next phase of progress is not waiting on a breakthrough device. It depends on greater discipline in how the field uses these tools: with clear evidence goals, thoughtful implementation, and a shared understanding of what works in practice. That is the case for the Library, and the case VivoSense and DiMe are making together: a visible, shared record of real-world implementation can help the field learn faster, build on prior work, and turn digital measurement from isolated innovation into trusted clinical development practice.

Explore the Library of Digital Endpoints, and learn more about VivoSense.