VivoSense
VivoSense is a specialized wearable sensor Contract Research Organization serving pharmaceutical sponsors, biotech firms, and digital health innovators with end-to-end wearable sensor implementation and digital endpoint services across clinical trials. Its proprietary cloud-based DHT platform and 14+ years of expertise support trials in 30+ countries and 20+ therapeutic areas.
- Company typePrivate
- Founded2010
- HeadquartersNewport Coast, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What VivoSense does
VivoSense, Inc. is a privately held, specialized Wearable Sensor Contract Research Organization (CRO) founded in 2010 and headquartered in Newport Coast, California. The company serves pharmaceutical sponsors, biotech firms, traditional CROs, and digital health innovators by providing end-to-end services for implementing wearable and connected digital health technologies (DHTs) in clinical trials. These services span three integrated phases: Study Startup (DHT strategy, sensor selection, protocol development), Study Conduct (device operationalization, monitoring, data collection, and transfer), and Study Closeout (data investigation, statistical analysis, and clinical validation). Named customer engagements include argenx (Phase 3b case study presented at the 2025 Digital Biomarkers Summit), Genentech/Roche (Clinical Trial Innovation Summit collaboration), GSK, RSRT, Boston Children's Hospital, Biogen, Mayo Clinic, and Newron.
The company's core technology is a proprietary, device-agnostic, cloud-based DHT platform that ingests, cleans, synchronizes, analyzes, and interprets wearable sensor data. The platform is described as compliant and auditable for use in regulated clinical trial environments and is paired with deep domain expertise across more than 70 wearable sensors, 20 therapeutic areas, and operations spanning 30+ countries. A flagship productized asset is MEADOW-RETT-BR, a DHT-based measure of apnea events in Rett syndrome patients co-developed with the Rett Syndrome Research Trust and Boston Children's Hospital, which received positive feedback from the EMA Innovation Task Force in December 2024.
VivoSense operates a B2B professional services revenue model with project-based, quote-determined pricing tied to study scope, duration, sensor requirements, and geographic reach. The company has raised approximately $27 million across its lifetime, including a $25 million Series A in March 2022 led by Perceptive Xontogeny Venture Fund and Debiopharm Innovation Fund. Distribution is exclusively direct enterprise sales, supported by thought leadership content (website, blogs, eBooks, webinars, peer-reviewed publications in journals such as Karger Digital Biomarkers and Frontiers in Digital Health) and active participation in industry coalitions including DiMe, DATAcc, FNIH, CTTI, CancerX, and ISPOR. Leadership comprises co-founder and CEO Dudley Tabakin, CSO Kate Lyden PhD, CTO Doug McAllister, Chief Algorithm Officer Ralf Hempfling, and functional VPs across sales, marketing, finance, engineering, science, quality, and clinical operations.
VivoSense firmographics
Firmographics- Name
- VivoSense
- Legal name
- VivoSense, Inc.
- Website
- https://vivosense.com
- Company type
- Private
- Founded year
- 2010
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- VivoSense is a specialized wearable sensor Contract Research Organization serving pharmaceutical sponsors, biotech firms, and digital health innovators with end-to-end wearable sensor implementation and digital endpoint services across clinical trials. Its proprietary cloud-based DHT platform and 14+ years of expertise support trials in 30+ countries and 20+ therapeutic areas.
- Ownership category
- akta.pro rank
VivoSense industry classification
Industry- Product category
- Clinical Research Services (Wearable Sensor CRO)
- NAICS
- Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Clinical CROs (Phase I–IV) (HLAGAAAA)
- akta.pro secondary industry
- Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF)
Keywords
Where VivoSense is headquartered
LocationHeadquarters
- HQ city
- Newport Coast
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
VivoSense business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales
Revenue model
- Wearable Sensor CRO Services: VivoSense generates revenue through providing end-to-end services for wearable sensor implementation in clinical trials. This includes DHT strategy consulting, sensor selection and operationalization, data collection and cleaning, and clinical validation services. The revenue model is project-based and service-oriented, working with pharmaceutical sponsors across clinical trial phases.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels7 records
VivoSense product offering
Product offeringCore offering
VivoSense operates as a dedicated Wearable Sensor Contract Research Organization (CRO), providing end-to-end services and a proprietary cloud-based Digital Health Technology (DHT) platform for implementing wearable and connected digital health technologies in clinical trials. Its offering spans Study Startup (DHT strategy, measure selection, protocol development), Study Conduct (operationalization, monitoring, data collection, data transfer), and Study Closeout (data investigation, statistical analyses, clinical validation) for pharmaceutical sponsors, traditional CROs, and digital health innovators across more than 30 countries.
Product overview
VivoSense operates as a Wearable Sensor Contract Research Organization (CRO) providing end-to-end services for wearable and connected digital health technologies in clinical trials. The company offers its proprietary VivoSense DHT Platform as the core technology infrastructure, complemented by three integrated service phases: Study Startup (DHT Strategy, Measure Selection, and Protocol Development), Study Conduct (DHT Operationalization, Monitoring, Data Collection, and Data Transfer), and Study Closeout (DHT Data Investigation, Statistical Analyses, and Clinical Validation). The company also develops specific digital health measures such as MEADOW-RETT-BR for rare disease applications. This unified platform-plus-services model enables pharmaceutical sponsors to integrate wearable sensor technologies throughout the clinical development lifecycle.
Differentiator
Problem solved
Functional benefit
Products and services
- VivoSense DHT Platform VivoSense's proprietary cloud platform for managing digital health technology implementation in clinical trials. It serves as a centralized location for DHT-related activities including data collection, cleaning, monitoring, analysis, and reporting, providing a compliant and auditable solution for wearable sensor data. Sold as part of VivoSense's wearable sensor CRO service engagements with pharmaceutical sponsors.
- Study Startup Services DHT Strategy, Measure Selection, and Protocol Development services including sensor recommendation based on study needs and data quality, design of data collection and processing procedures, and digital health technology vendor relationship management to streamline clinical operations. Sold as part of VivoSense's wearable sensor CRO service engagements with pharmaceutical sponsors.
- Study Conduct Services DHT Operationalization, Monitoring, Data Collection, and Data Transfer services utilizing the VivoSense Platform for device deployment, site training, compliance tracking, and continuous data capture and cleaning. Sold as part of VivoSense's wearable sensor CRO service engagements with pharmaceutical sponsors.
- Study Closeout Services DHT Data Investigation, Statistical Analyses, and Clinical Validation services including feasibility assessment, treatment response evaluation, clinical validity establishment, and regulatory-ready reporting. Sold as part of VivoSense's wearable sensor CRO service engagements with pharmaceutical sponsors.
- MEADOW-RETT-BR Digital Health Measure MEADOW-RETT-BR is an innovative digital health technology-based measure of apnea events in patients with Rett syndrome, developed by VivoSense with the Rett Syndrome Research Trust and Boston Children's Hospital and currently undergoing EMA qualification for regulatory acceptance. It represents a specific digital endpoint that VivoSense develops and validates for rare disease applications.
Quantifiable outcome
- 99% data availability achieved in cystic fibrosis trial with 200 devices across 18 sites worldwide
- +4 more outcomes
Companies that use VivoSense
Customer profileNamed customers6 records
Segments3 records
Ideal customer profiles3 records
VivoSense technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
VivoSense partnerships and signals
Strategic signalPartnerships
13 partnerships are on record, tiered minor, flagship and core.
- OCT UK & Ireland 2026 ConferenceminorCEO Dudley Tabakin presented at OCT UK & Ireland 2026 conference in London, discussing barriers to wearable adoption in clinical trials and achieving regulatory acceptance for digital endpoints.
- argenxflagshipStrategic partnership for end-to-end wearable sensor CRO services. Presented joint case study at 2025 Digital Biomarkers Summit showcasing how VivoSense's operational oversight improved Phase 3b study outcomes to 95.3% valid data days. Partnership spans strategy development, measure selection, operationalization, and regulatory strategy.
- RocheminorHost venue for the 8th Annual Digital Biomarkers in Clinical Trials Summit 2025. VivoSense and argenx presented joint case study at this flagship industry event.
- Rett Syndrome Research Trust (RSRT)corePartner in MEADOW-RETT-BR digital health measure qualification for Rett syndrome. Collaboration focused on developing DHT-based measure of apnea events to support regulatory qualification with EMA and advance novel therapies for rare disease.
- Boston Children's HospitalcoreClinical partner in MEADOW-RETT-BR measure development for Rett syndrome. Working with VivoSense and RSRT on qualification of DHT-based apnea measurement with EMA Innovation Task Force.
- GenentechcoreCEO Dudley Tabakin led panel at Genentech's Clinical Trial Innovation Summit. Collaboration on digital biomarker implementation discussions with GSK and gRED representatives. VivoSense presented on the Wearable Sensor CRO model and digital measure adoption.
- GSKminorDr. Sachin Shah, Digital Biomarker Lead at GSK, participated in Genentech panel with VivoSense CEO, discussing operational demands of wearable sensor data at scale and regulatory submission approaches.
- DiMe (Digital Medicine Society)coreVivoSense joined DATAcc DiMe project 'Building the Business Case for Digital Endpoints' - a joint collaboration between DiMe and FDA. Contributed to Digital Endpoints ROI Calculator, Value Framework, and Case Study Catalog. Active contributor to DiMe Projects including Playbook, Core Measures of Physical Activity, and Core Measures of Sleep.
- DATAcc (Digital Health Measurement Collaborative Community)coreCollaborative community with FDA's Center for Devices and Radiological Health. VivoSense contributes to establishing shared industry benchmarks for evaluating ROI of digital endpoints in drug development. Partner includes Tufts and FDA.
- FNIH (Foundation for the National Institutes of Health)coreVivoSense is a member of both the Cancer and Neuroscience FNIH Biomarker Steering Committees. FNIH connects leading public and private organizations to accelerate biomedical breakthroughs through the Biomarkers Consortium.
- CTTI (Clinical Trials Transformation Initiative)coreVivoSense is committed to CTTI's mission to build better, faster clinical trials. CTTI convenes 80+ members and 500+ multi-stakeholder organizations to develop and drive adoption of practices increasing clinical trial quality and efficiency.
- CancerXcorePublic-private partnership to boost innovation in cancer. Co-hosted by Moffitt Cancer Center and DiMe, alongside ONC and OASH. VivoSense participates to advance digital health technologies in oncology research.
- ISPORminorVivoSense participates in ISPOR, the leading global scientific organization for health economics and outcomes research. Promotes HEO/R excellence to improve decision-making for health globally.
Scale indicators8 records
Recent moves6 records
Expansion highlights5 records
VivoSense competitors and assessment
Company assessmentBroad incumbents
- Medidata (Dassault Systèmes): Enterprise clinical trial platform owned by Dassault Systèmes with sensor ingestion, eCOA, and decentralized trial capabilities via Rave. Competes with VivoSense at the platform layer for wearable data capture and analysis in pharma-sponsored trials.
- IQVIA: World's largest CRO with expanding digital health, real-world evidence, and connected device capabilities. Overlaps with VivoSense in wearable sensor deployment and digital endpoint services, particularly across large global Phase III programs.
- ICON plc: Top-tier global CRO with a growing digital endpoints and decentralized trials practice (post-PRA Health and Symphony Clinical Research integrations). Broad incumbent competing for the same wearable CRO budgets as VivoSense.
- Clario: Large clinical trial technology company (formed from ERT and Bioclinica) offering eCOA, imaging, and increasingly wearable sensor / digital endpoint solutions to pharma sponsors. Broad incumbent competing with VivoSense in the digital endpoint layer of clinical trials.
Emerging players
- Medable: Decentralized clinical trial technology platform with integrated eCOA, ePRO, and connected device / wearable sensor modules. Competes with VivoSense in enabling sponsors to operationalize wearable data in clinical trials, though more platform- and less service-led.
- Science 37: Decentralized clinical trial operator that integrates wearable sensors and remote data capture for sponsor studies. Comparable to VivoSense in its emphasis on wearable-derived digital endpoints in decentralized/hybrid trial designs.
- ObvioHealth: Decentralized and hybrid clinical trial CRO with integrated wearable sensors and digital endpoints. Competes with VivoSense for sponsors seeking end-to-end DCT execution with wearable-derived outcomes.
Others
- Evidation Health: Real-world health data and digital measurement platform leveraging wearables and connected devices, with applications in clinical research and patient-generated evidence. Thematically adjacent to VivoSense's wearable data business, primarily outside the regulated clinical trial endpoint layer.
Direct peers
- ActiGraph: Wearable sensor hardware and analytics provider widely used in clinical research, including clinical-grade actigraphy for digital endpoints. Comparable to VivoSense as a specialized wearable data provider for clinical trials, though more hardware-centric.
- Koneksa Health: Direct competitor offering a wearable sensor / digital biomarker platform and CRO-style services for clinical trials. Overlaps with VivoSense on device-agnostic sensor capture, digital endpoint validation, and pharma sponsor customers in respiratory and rare disease.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
VivoSense social profiles
Digital presenceVivoSense financial estimates
Financial estimateRevenue estimate
Valuation estimate
VivoSense leadership team
Management profileNumber of profiles
Profiles9 records
VivoSense funding detail
Funding detailFunding overview
Funding rounds3 records
Investors4 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
VivoSense M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about VivoSense
What does VivoSense do?
VivoSense operates as a dedicated Wearable Sensor Contract Research Organization (CRO), providing end-to-end services and a proprietary cloud-based Digital Health Technology (DHT) platform for implementing wearable and connected digital health technologies in clinical trials. Its offering spans Study Startup (DHT strategy, measure selection, protocol development), Study Conduct (operationalization, monitoring, data collection, data transfer), and Study Closeout (data investigation, statistical analyses, clinical validation) for pharmaceutical sponsors, traditional CROs, and digital health innovators across more than 30 countries.
Is VivoSense a public or private company?
VivoSense is a private company. It is classified as venture growth investor backed and is currently operating.
When was VivoSense founded?
VivoSense was founded in 2010. It employs 11 to 50 people.
Where is VivoSense based?
VivoSense is headquartered in Newport Coast, United States, in the North America region.
How does VivoSense make money?
One revenue line is on record: wearable Sensor CRO Services.
Who are VivoSense's main competitors?
Broad incumbents on record are Medidata (Dassault Systèmes), IQVIA, ICON plc and Clario. Emerging players are Medable, Science 37 and ObvioHealth. Evidation Health is listed as an others. Direct peers are ActiGraph and Koneksa Health.
Does VivoSense have an API?
No public API is recorded for VivoSense.
What industry is VivoSense in?
VivoSense's product category is Clinical Research Services (Wearable Sensor CRO). Its primary akta.pro industry code is HLAGAAAA, Clinical CROs (Phase I–IV), with a secondary code of HLAGAAAF, Clinical Data Management, Biostatistics & Statistical Programming CROs. Its NAICS code is 5417 and its SIC code is 8731.