Decentralized and hybrid trials continue to grow in popularity, making it essential for contract research organizations (CROs) to seamlessly integrate remote wearable technologies into trial operations. Traditional, site-based trials often miss meaningful changes between participant visits, so remote wearable devices are appealing because they improve study quality through continuous, real-world data collection. One study showed that a 14-day adhesive ECG patch detected arrhythmias in 59.5% of patients, compared to 19% with a traditional 24-hour Holter monitor, demonstrating the potential of wearable devices.
To be truly effective, however, wearable solutions need to closely collaborate with CROs and understand their workflows, support patient adherence, and translate complex data into actionable insights. Additionally, as sponsors are moving beyond just evaluating data quality, tech partners that can support patient comfort and data translation are increasingly necessary.
Experienced digital health solution vendors play a key role in helping ensure trial success because they can help CROs and sponsors navigate the complexities of remote data flow while simultaneously maintaining consistency across diverse trial environments globally. A recent collaboration between a clinical wearables technology developer and a global, full-service CRO, showcased this dynamic in practice.
The two organizations worked together to implement remote cardiac monitoring across a large, multicenter trial, using an FDA-cleared remote ECG recording device. The trial’s goal was to study disease progression and new drug safety in patients diagnosed with pulmonary hypertension and heart failure, with the CRO owning the operational and regulatory layer, including site coordination, data management, protocol compliance, and quality oversight. The technology partner owned the technology layer, including platform validation, device logistics, and tiered technical support.
The study demonstrated what a successful infrastructure requires: a partnership between a CRO that understands the regulatory landscape, protocol complexity, and site dynamics, and a technology vendor whose scope extends beyond the device itself to cloud-based data platforms and real-time technical support. That broader scope is essential to solving real-world complications no device specification alone could anticipate.
Navigating Patient Accessibility and Lifestyle
It’s very common in decentralized clinical trials to account for patient accessibility, and age-related factors impact compliance and data integrity, which means ensuring that proper support is provided for use of the monitoring devices. As shown in this pulmonary hypertension study, a number of participants had limited experience with wearable technology, with participant-reported operational issues observed in 3.2% of assigned ECG kits. In order to overcome those issues, the partnership responded with proactive adherence monitoring, simplified training protocols provided to patients, as well as a clearly defined path for remote troubleshooting.
Connectivity and the variability of daily lifestyles introduce additional trial challenges, since participants in remote areas often experience disruptions to real-time data transmission from Wi-Fi and cellular access issues. Daily lifestyle changes such as traveling across time zones can affect time stamps for patients, causing further complications. The above-mentioned partnership addressed these issues through alternative recovery solutions, advising patients to intermittently travel to areas with stable internet access so the device could transmit accumulated data. Additional interventions such as travel notification reminders, reinforced wearables guidance, and re-recording requests helped ensure data quality across the study.
Overcoming Wearable Supply Challenges
For large multicenter trials, high patient screening volumes can cause a substantial demand for remote device kit shipments, which requires the vendor-CRO partnership to develop a fast-paced logistics workflow to ensure sites are supplied when needed. As the number of patients participating can not always be predicted, expedited shipments help prevent gaps in device availability.
Furthermore, in large studies, some device kits may be misplaced or discarded accidentally. As shown in the above-mentioned pulmonary hypertension trial, over the course of the trial, 7.2% of issued ECG kits experienced partial or complete component loss, particularly from those unfamiliar with wearable technology. The partnership responded by strengthening site training, implementing refresher sessions, and clarifying accountability procedures for patient and caregiver instruction. Because the trial platform stored data in the cloud, device loss did not result in data loss, a distinction that reflects the importance of system architecture in large-scale trial design.
Collaborating on safeguards needs a broader point for partnership in trials. Successful integration of wearable technology heavily depends on partners that can anticipate real-world barriers and react with support to both sites and patients during the study, by combining flexible technology with operational experience, to maintain data integrity in complex, real-world conditions.
Implications for CRO-Vendor Integration
The value of continuous monitoring is not unlocked by the device alone, but also through the system surrounding it. Data workflows, site coordination, patient support, and regulatory alignments all play a critical role in turning continuous data into meaningful clinical insights. Working with CROs to integrate smoothly into clinical workflows enables the next level of performance that ensures trial success.
As the adoption of wearables continues to grow, the demands for integration, data quality, and responsiveness will as well. Success will require thoughtful implementation and experienced partnerships that can work effectively together to ensure that wearable data is reliable and actionable. As the tech vendors know more about various clinical workflows, their adaptations and integrations will become better, growing with the market needs.
About Cecilia Xi, PhD
Cecilia Xi, PhD, is the VP of Clinical and Scientific Affairs at Vivalink, focusing on clinical and scientific strategies to further the adoption of medical devices and refine their capabilities. Her experience encompasses a broad range of class II and III medical devices including pacemakers, ICDs, CRTs, subcutaneous monitors, left atrial pressure systems, SCS devices, remote care systems, devices for cardiothoracic surgery, intravascular robotics and wireless telehealth (IoHT) wearable devices.
