The following is a guest article by Jiang Li, CEO at Vivalink
Decentralized and hybrid clinical trials gained traction out of necessity. During the pandemic, many teams had to shift quickly to telehealth, remote monitoring, and digital tools to keep research going. Since then, researchers have been increasingly adopting these models to capture real-time data, reduce participant burden, and improve access.
With the FDA finalizing guidance in late 2024, sponsors have clearer direction on how to incorporate tools like telehealth, remote data capture, and home health visits into trial designs. And while wearables were once limited to pilot studies, recent guidance and sponsor activity show that they’re now gaining traction in later-phase trials, where maintaining data integrity and monitoring adherence are essential.
But as decentralized models become more common, managing a patchwork of disconnected systems is increasingly unsustainable, especially as research teams face staffing cuts, delayed grants, and tighter timelines. Under this kind of pressure, disconnected tools are harder to manage. Trial teams don’t have the time, support, or infrastructure to manually piece together data across platforms.
Integration needs to be a priority from the outset. And technology plays a key role in helping teams do more with less, including keeping participants engaged, enabling real-time monitoring, and maintaining data quality across sites. But without interoperability, those same tools can introduce new complexity instead of reducing it.
When Systems Don’t Connect, Research Stalls
DCTs and hybrid trials rely on a mix of technologies to collect data, including wearables, mobile apps for patient-reported outcomes, telehealth platforms, lab systems, and dashboards for monitoring. But more often than not, these systems operate in isolation.
Biometric data is often stored in the cloud. Symptom tracking apps may feed into separate platforms. Lab results come through third-party portals, while telehealth notes live in another system entirely. Without integration, trial teams must manually cross-check timelines, reconcile data across systems, and track down missing information. Consider a typical hybrid trial site coordinator. On Monday, they download CSV files from a wearable vendor’s portal. On Tuesday, they manually re-format that data to match the ePRO system. On Wednesday, they upload it to the EDC, hoping there are no errors that trigger a query.
That fragmentation increases the risk of delays and missed insights. In its recent report, the Clinical Trials Transformation Initiative emphasized that fragmented systems make it harder for trial teams to work efficiently and for sponsors to trust the data. The report noted that without such integration, the potential benefits of DCTs, such as increased participant diversity and improved data quality, may not be fully realized.
Platforms that support interoperability across devices, patient-reported outcomes, lab systems, and dashboards reduce friction, minimize manual work, and give teams better visibility into how a trial is running. Now, imagine that same coordinator. Real-time data from the wearable flows directly into the EDC, fully formatted as SDTM data. Alerts are routed automatically. The coordinator’s time is freed up to focus on what matters: patient care and retention. Sponsors that plan for integration early are better positioned to keep trials on track, even as staffing and resources remain under pressure.
What an Interoperable System Looks Like in Practice
Disconnected systems create unnecessary work for trial teams, and even when tools are integrated, the process still requires planning and coordination. In a hybrid cardiac safety trial, a global CRO used wearable sensors to monitor patients’ ECGs and vital signs remotely across three separate 48-hour monitoring windows.
To support this design, the CRO used Vivalink’s platform to bring biometric and adherence data into one system. Trial teams could monitor activity in real time, receive alerts when uploads were missed or usage patterns changed, and use dashboards to quickly identify when participants needed support.
The technology didn’t remove the need for oversight, but it reduced the amount of manual follow-up required. With the right systems in place, the team maintained protocol adherence, responded faster, and minimized disruptions without adding to their workload.
Research Is Under Strain
Even as hybrid trials and DCTs become more common, the resources to support them are shrinking. The Department of Health and Human Services is undergoing major restructuring, with plans to eliminate 20,000 positions, including roles at the NIH and FDA. At the same time, a new federal policy capping overhead reimbursement for research institutions has led to grant delays, staff reductions, and scaled-back trial operations across universities and academic medical centers.
These changes have direct consequences for trial execution. In this environment, interoperability allows trial teams to keep studies moving without burdening already stretched staff. When platforms connect, teams can spend less time chasing data and more time focusing on the research. And when the tools are adaptable enough to match the needs of each protocol, research teams can adapt without rebuilding workflows from scratch.
In many cases, wearables and decentralized tools also enable researchers to launch new or expanded trial designs. Sponsors can segment studies into more targeted arms, add observational extensions, or bring research to populations that couldn’t participate before.
What Sponsors Can Do Next
The research environment has changed. Institutions are losing staff. Grants are delayed. Teams are stretched thin, trying to hold complex studies together with fewer resources. Every decision carries more weight, especially when it comes to how trial systems are designed, how tools are selected, and how teams are supported.
Planning for integration allows trial teams to set up systems that support real-time monitoring, catch issues as they arise, and reduce the risk of costly delays. Disjointed technology won’t solve staffing shortages or restore lost funding. But when devices and platforms are built to work across systems, they can ease the burden on trial teams, protect data quality, and help research continue.
