As clinical research pivots toward decentralization, the challenge of ensuring accurate, continuous, and patient-friendly data collection has taken center stage. Sponsors and sites now seek solutions that not only capture complex physiological signals in real time but also make the experience simple for participants.

Vivalink, a digital health innovator, is working on redefining how remote patient monitoring (RPM) powers modern trials. In a recent joint session with Clario, Vivalink showcased how its integrated platform, combining medical-grade wearables, edge computing, and cloud-based data services, is helping sponsors streamline cardiac safety monitoring across sites and participants. The system’s flexibility allows seamless interoperability between Vivalink’s own sensors and hundreds of third-party devices, offering a unified view of participant data.

“Our Digital Health Technology Platform is designed for flexible interoperability with clinical applications, EHRs, and trial management systems,” explains Mariel Fabro, Vivalink’s Head of Product, in an interview with Drug and Device World. “It integrates medical-grade sensors, edge computing, and cloud data services for both continuous and episodic monitoring. Sponsors can combine multiple vital streams—heart rate, ECG, blood pressure, and more—into one view rather than juggling separate feeds.”

The Human Side of Integration

While Vivalink’s technology is sophisticated, Fabro emphasizes that its design philosophy begins with the participant experience. Wearable devices must be accurate and compliant, while also being simple, comfortable, and easy to use.

“Our devices are built to passively capture and transmit data,” Fabro notes. “We minimize participant steps and prioritize comfort with reusable adhesive patches, rechargeable options, and materials suited for daily living.”

For sites and sponsors, the platform’s centralized portal eliminates manual work. Study staff can monitor participant status, view compliance dashboards, and receive alerts when devices are disconnected or need attention. “With real-time visibility,” says Fabro, “sponsors can prompt a participant to reapply a patch or schedule a quick televisit instead of waiting for the next site visit.”

Fabro noted that a recent case study showcased the power of Vivalink’s integrated approach in a cardiac safety monitoring trial. The results revealed how an interconnected system can replace fragmented monitoring processes, improve compliance, and reduce operational burden.

“The participants, sites, and sponsors were all connected through the Vivalink platform,” Fabro says. “This allowed for real-time cardiac event monitoring, flexible participation, and submission-ready data validated through our partner Clario.”

The approach not only streamlined workflows but also boosted confidence in data quality, a critical factor in any regulated environment. “Our Biometric Data Platform complies with the highest global standards, including FDA, HIPAA, GDPR, and ISO certifications,” Fabro explains. “It continuously monitors data integrity and triggers alerts for any anomalies.”

What Patients Really Want

Technology may power decentralized trials, but patient trust keeps them running. A Vivalink survey of over 200 US adults, 90% said they were open to fully remote trials, and 52% were very likely to join one from home. The key drivers? Simplicity, support, and safety.

Respondents highlighted the importance of easy-to-use devices, clear communication, and FDA-cleared technology. Over half said access to tech support and step-by-step guides helped them feel confident using wearables. Comfort was also critical, with many participants saying they would leave a trial early if the technology was confusing or uncomfortable.

“People are willing to join remote or hybrid trials when the experience feels human,” Fabro says. “By capturing data in daily life rather than in a clinic, we reduce the travel burden and open the door to participants who might otherwise be excluded—like those in rural areas.”

The Road Ahead

For Fabro, the future of remote monitoring goes far beyond convenience. She envisions a data-driven ecosystem where digital biomarkers, predictive analytics, and real-world evidence converge to enhance both research and care.

“Remote patient monitoring is laying the foundation for a connected continuum between healthcare and clinical trials,” she says. “We’ll see digital profiles for risk stratification, predictive models for therapeutic response, and personalized medicine guided by real-world physiologic data.”

Yet, she acknowledges the path forward isn’t without friction. “Integrating technology into clinical workflows can be challenging,” Fabro notes. “Regulatory harmonization takes time, and interoperability across healthcare and trial systems remains an area for improvement. But every step toward standardization brings us closer to trials that are smarter, faster, and more inclusive.”

Fabro acknowledged that “in the case of these technologies being utilized in the clinical trial domain, the FDA has done a good job over the last few years developing frameworks and guidances on digital health technologies, real-world evidence, and related paradigms for clinical research purposes. This helps to establish a standard, but often global harmonization takes time.” Adding, “there is a broad range of technologies that can be considered “DHT,” so the first generation of guidances may not have fully considered the possible implementations.”

Opening Up Possibilities

Remote patient monitoring is part of the foundation for a connected continuum for both healthcare and clinical trials, and even bridging between the two domains, notes Fabro.

According to Fabro, “in the context of clinical trials, remote patient monitoring is poised to enhance various aspects of patient care and research significantly. It can facilitate the creation of digital profiles or digital twins that assist in risk stratification and optimizing patient recruitment. Additionally, predictive analytics will likely play a crucial role in forecasting patient responses to therapeutic regimens and minimizing safety issues. By establishing a real-world physiological profile of individuals, remote monitoring can complement the real-world evidence (RWE) and real-world data (RWD) framework, taking into account patients’ daily activities, routines, and environments. Furthermore, the data gathered through this approach can contribute to the development of complex models for personalized medicine, ultimately being integrated into therapeutic regimens for improved patient management and care.”

Vivalink’s integrated RPM platform demonstrates that successful decentralized trials hinge on both technological intelligence and human insight. By weaving usability, compliance, and interoperability into one digital fabric, Mariel Fabro and her team are showing the industry what truly connected research looks like.

“Our goal,” Fabro says, “is to make remote monitoring not just possible—but seamless, reliable, and centered around the participant.”