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.

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