Articles and Insights About Wearables for Clinical Trials

Digital Endpoints

Biomarkers vs. Clinical Outcome Assessments (COA) vs. Endpoints

Posted by Kate Lyden on October 29, 2020

COAs, Biomarkers, and Endpoints, Oh My!

Establishing a common vocabulary accelerates progress by enabling effective communication and collaboration among stakeholders and facilitating cross-study comparisons and evidence harmonization. However, when we work with clinical researchers, they often use the words biomarkers, clinical outcome assessments (COA’s), and Endpoints interchangeably, but technically they mean different things.

I’m confident that my amazing team members often think I’m crazy when I deliberate or nitpick over the use of a single word. The point is words matter, especially in science and definitely in a new field like digital medicine. As this field evolves, definitions and key terms must be used consistently to reduce the hindrance of evaluating and interpreting scientific evidence.

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VivoSense Awarded NIH/NCI Grant to Aid in Cancer Research

Posted by Dudley Tabakin on October 15, 2020

VivoSense, Inc. is proud to announce that we have been awarded an NIH/NCI Phase 1 contract to develop software enabling data integration from wearable sensors for cancer patients. The contract will result in the development of the VivoSense Cancer Health Informatics Platform as the leading wearable sensor agnostic cloud platform for cancer research and clinical care.

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Developing Digital Biomarkers Post Covid-19

Posted by Dudley Tabakin on July 9, 2020

The 3rd Annual Digital Biomarkers in Clinical Trials Summit hosted by Roche was the virtual place to be in June, bringing together 250+ global thought leaders and experts. They shared insights on developing and improving the way pharma clinical trials utilize mobile-enabled, wearables, and IoT capabilities to augment existing biomarker strategies, improve patient experience, and collect better data.

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Digital Biomarkers to Address COVID-19 Symptoms and Progression

Posted by Dudley Tabakin on April 2, 2020

The US and international effort to address the novel Coronavirus (COVID-19) pandemic is unprecedented. Experts from healthcare, public health, and policy are joining forces with experts in manufacturing and technology for the rapid deployment of innovative, lifesaving solutions. VivoSense, an expert in remote monitoring of physiological signals, is contributing to this effort through their advanced data analytics and Human Augmented AI platform.

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RSRT Partners with VivoSense to Develop Digital Biomarkers

Posted by Dudley Tabakin on March 17, 2020


Image Source: RSRT, Randol Family

VivoSense announces a series of new collaborations with the Rett Syndrome Research Trust (RSRT) to develop digital biomarkers that better assess the symptoms of Rett syndrome, focusing on autonomic dysfunction and other difficult-to-evaluate symptoms. The goal in developing these digital biomarkers is to better quantify and understand symptom impact on everyday life and to assess new treatments accurately.

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VivoSense® Plays Vital Role in Respiratory Monitoring in Infants

Posted by VivoSense Team on March 5, 2020

Severe respiratory disease is one of the leading causes of infant illness and death worldwide. There is a significant upward trend of clinical infant respiratory studies, including the investigation into respiratory success in ventilated infants, SIDS, and neurological disorders that affect the normal respiratory pattern. In this article, we discuss how noninvasive respiratory monitoring and VivoSense® software helps researchers collect and analyze respiratory data for clinical studies focused on infant and neo-natal breathing patterns.

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VivoSense® Provides the Solution to Accurate Volume Measures Derived from RIP

Posted by Dudley Tabakin on March 21, 2017

Respiratory inductance plethysmography (RIP) is a method for evaluating breathing characteristics by measuring the movement of the thorax and abdominal wall. RIP acquires respiratory data via two elastic bands placed around the rib cage (RC) and abdomen (AB), and thus, must be calibrated to provide accurate volume metrics.

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VivoSense Facilitates Novel Respiratory Studies in Premature Infants

Posted by Dudley Tabakin on February 7, 2017

VivoSense continues to lead the way in infant respiratory analysis.

Orange County, CA, February, 2017 – Washington University School of Medicine, and St Louis Children’s Hospital with funding from the NIH Prematurity and Respiratory Outcomes Project (PROP) https://clinicaltrials.gov/ct2/show/NCT01435187 have published early research findings. The primary goal of the PROP study was to identify biomarkers and clinical variables in premature infants that would potentially predict pulmonary status up to one year later.

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Vivonoetics to Provide Advanced Respiratory Assessment for SMA-1 Clinical Trial

Posted by Dudley Tabakin on January 24, 2017

Roche’s Firefish clinical trial will evaluate drug efficacy against respiratory muscle function and breathing patterns in infants treated for SMA.

Orange County, CA, January, 2017 – Vivonoetics Inc., developer of VivoSense® respiratory testing solutions, announced today that in partnership with Great Lakes NeuroTechnologies, they will be providing advanced respiratory assessment to the Roche FIREFISH study.

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Vivonoetics Partners with Beddit to Provide Contact-Free Monitoring of Sleep and Vital Signs

Posted by Dudley Tabakin on August 20, 2013

Vivonoetics Inc., developer of VivoSense® clinical research management and analysis software, announced today that they have partnered with Beddit, Inc., leading innovators in contact-free sleep and vital sign monitoring technology. The partnership will provide pharmaceutical companies and research organizations a practical and cost effective solution for long-term monitoring of sleep and vital signs, enabling more effective and efficient evaluation of new and existing treatments.

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