Vivalink is trying to support medical research organizations that are conducting clinical trials in a post-COVID environment. The company noted that many medical processes have been decentralized due to social distancing concerns, which means that doctors and clinicians need a way to track medical outcomes for trial participants who have never stepped foot inside a lab.
With that in mind, Vivalink has upgraded its Biometrics Data Platform to provide researchers with the turnkey hardware and software they need to conduct a decentralized clinical trial (DCT). The complete kit includes wearable devices that can track a range of vital signs, as well as data management and analytic software to help researchers make sense of the information they record. The analytic software has FDA approval, while the data itself is compatible with existing Clinical Trial Management Systems (CTMS).
Vivalink will ship devices to test locations all over the world, and will provide ongoing support services for organizations that are conducting trials. The company believes that DCTs will become increasingly common in the future, after conducting a survey that found that 44 percent of pharma and biotech professionals are already using remote patient technology in their trials, or are planning to launch a remote trial within the next year. The majority (65 percent) made that decision to minimize the health risks associated with COVID-19.
“Vivalink automates every aspect of remote patient data collection, transmission, management, and integration on behalf of the trial sponsors, making it easy for the clinical research team to focus on uncovering critical insights that impact drug development,” said Vivalink CEO Jiang Li. “Our global regulatory compliance, and experience providing an open data platform puts us in a unique position to facilitate the technical and qualitative aspects of dealing with data capture and processing in real world environments.”
Vivalink’s technology has been used in a wide variety of clinical trials, covering everything from drug safety to depression to heart disease. The company first revealed that it was working to update its Biometric Data Platform to support remote clinical trials in August.
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October 5, 2021 – by Eric Weiss
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