Building the Business Case for Digital Endpoints: A Collaborative Effort by DATAcc and DiMe 

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Vivosense is pleased to announce it has joined the DATAcc DiMe project – Building the Business Case for Digital Endpoints. This initiative is a joint collaboration between DiMe and the FDA. Together, they aim to enhance the understanding and adoption of digital technology to improve clinical trials.

The primary objective of this project is to establish shared industry benchmarks. These benchmarks will evaluate the ROI of digital endpoints in the development of drugs, medical devices, and other regulated interventions. Consequently, the project aims to support organizations in building the business case for digital endpoints. By doing so, it advances the development, implementation, and scaling of fit-for-purpose digital measures in clinical trials.

Dudley Tabakin, Vivosense co-founder and Chief Product Officer, commented, “Vivosense has a 13-year history in developing and deploying digital endpoints in clinical trials. As a company, we have a passion for improving the efficiency and efficacy of the drug development process and patient care. Furthermore, we have been fortunate to support several DiMe projects to help advance the understanding and use of digital endpoints. Therefore, we look forward to collaborating with DiMe, Tufts, FDA, and our other partners on this project. Our goal is to enhance the understanding and development of a consistent framework for evaluating Return on Investment with digital endpoints.

About DATAcc by DiMe

The Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) is a collaborative community with the FDA’s Center for Devices and Radiological Health. It provides a forum for collaboration where partners and experts from across the digital health field work together. Additionally, our aim is to advance the use of digital health measures in research to improve lives.

About VivoSense

Since 2010, VivoSense has been revolutionizing clinical trials by developing and deploying digital endpoints from wearable devices. Our team of experts and proprietary cloud platform add value at every phase of a clinical trial. From trial design to sensor selection and operationalization, data capture, cleaning, and analysis, our deep scientific knowledge and extensive clinical trial experience have been instrumental. Moreover, we help clinical researchers analyze and interpret wearable sensor data, thereby enhancing patient research and care.

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