Vivosense, Inc.

VivoSense, Inc. operates as a specialized Contract Research Organization (CRO) focused exclusively on wearable sensor technologies and digital health technologies (DHT) for clinical trials. Based in Newport Beach, California, the company has operated for 14+ years across more than 20 therapeutic areas and 30+ countries, working with pharmaceutical companies, CROs, and digital health innovators to implement sensor-based data collection in clinical research.

The company provides end-to-end services spanning study startup through closeout, including DHT strategy development, device selection and vendor management, protocol development, data collection operationalization, and sensor data analysis. VivoSense has worked with over 70 different wearable sensor types and maintains a proprietary DHT platform for compliant, auditable clinical trial data management. Their clinical operations and data science teams focus on transforming high-volume sensor data into structured clinical endpoints.

Notable work includes advancing MEADOW-RETT-BR, a digital health measure for apnea events in Rett syndrome patients, which received positive feedback from the European Medicines Agency (EMA) in 2024. The company has partnered with organizations including Biogen, Roche, argenx, and Mayo Clinic on digital biomarker implementation.

Organizations should consider VivoSense when clinical trial success depends on high-quality wearable sensor data and digital endpoints. The company's specialized focus addresses the common challenge of pharmaceutical sponsors struggling to extract meaningful insights from wearable technologies, offering both technical expertise and clinical operations support.

Engagements typically involve comprehensive DHT lifecycle management, from initial strategy and device selection through final statistical analysis and regulatory submission support. The approach is particularly relevant for trials in therapeutic areas where digital biomarkers provide advantages over traditional clinical assessments.

VivoSense operates exclusively within pharmaceutical and biotechnology clinical research, focusing on digital health technology implementation for regulatory-grade clinical trials. The company's healthcare specialization centers on transforming wearable sensor data into validated clinical endpoints across therapeutic areas including rare diseases, neurology, and respiratory conditions.

Their work directly supports drug development processes, with experience in regulatory interactions with agencies like the EMA for digital measure qualification. The company addresses healthcare-specific challenges including clinical data quality, regulatory compliance for digital endpoints, and integration of novel sensor technologies into traditional clinical trial workflows.

The ideal client is a pharmaceutical company, biotechnology firm, or traditional CRO conducting clinical trials in therapeutic areas where wearable sensors and digital biomarkers can provide objective, continuous patient monitoring. Organizations benefit most when they require comprehensive vendor management, data processing expertise, and regulatory strategy for digital endpoints rather than simply technology procurement.