Empatica Health Monitoring Platform for Clinical Trials
Empowering clinical research with high-precision digital measures
Enhance your decentralized clinical trials with validated digital biomarkers and raw physiological data of the highest quality, from an FDA-cleared, full-stack platform designed to reduce patient and site burden across every therapeutic area. Conducting research at scale from patients' homes has never been easier.
Scale your research across studies and therapeutic areas with a single platform
Scalable
Scalable across studies and geographies, with simultaneous data collection from thousands of devices and multiple language support
Modular
One multi-use, adaptable wearable that can be worn across different areas of the body depending on your study needs
Reliable
Secure and compliant FDA-cleared technology and dozens of accurate digital measures, for guaranteed quality data
<2 months
from contract signing to starting data collection in your decentralized trial
>90% compliance
with EmbracePlus used as an actigraphy sensor¹
120+ Industry sponsored trials
have already implemented our Platform across multiple therapeutic areas
The only tool you need to remotely collect health data for your decentralized trials
Empatica's end-to-end platform covers every step of a decentralized clinical trial: remote patient enrollment, wearable device provisioning and shipping, continuous automated data collection, and clinical data management. Whether you are running a Phase IIa study or a global Phase III pivotal trial, the same platform, the same devices, and the same data quality apply.
Empatica Cloud
A full-stack, unified solution that’s built to work together
Cloud to Cloud
Use your own cloud while combining Empatica’s hardware and software for data collection and streaming. Discover Empatica's Cloud API
Designed for the patient
- Reduce burden and maximize compliance in decentralized research
- All data is collected via Empatica’s medical-grade wearables, with a modular design, comfortable materials, waterproof capabilities, and extended battery life, designed to be worn in daily life
- Data is streamed via a smartphone app that is simple to use and install on popular smartphone models. The app is translated into over 40 languages, with more continuously being added, allowing you to enhance diversity in your research without disadvantaging participants
- Setup is fast and easy, and can be done autonomously with the support of dedicated patient materials
- Battery life can last up to 28 days, reducing charging time
Made to support global trial operations
- Remote and secure enrollment, participant, and study management through the Care Portal
- Data collection and streaming to the Cloud is continuous and automated, thanks to the EmbracePlus and EmbraceMini capabilities
- Continuous support by a dedicated team, help desk, and materials, covering site and patient needs across every step of your study
- Empatica’s experienced team handles all logistics, including device shipping, replacement, and returns
- Sites receive frequent adherence reports via email, so that staff can quickly intervene when they identify compliance issues
- Regulatory support and audit trails, including IRB/Ethics committee-friendly materials
- Empatica performs frequent testing and certification of new phone models, and provides provisioned phones, to ensure technological compatibility
Validated across therapeutic areas
- Neurology & movement disorders support digital biomarker assessment through multimodal biosignals (EDA, PPG, actigraphy)
- CNS, psychiatry & mental health support insights into sleep, circadian rhythms, stress, and activity patterns
- Oncology & rare disease support fatigue, mobility, and functional activity outcomes
- Cardiovascular supports heart rate, HRV, IBI, and pulse dynamics
- Pain & musculoskeletal supports gait, activity, and sleep disruption
- Sleep disorders support TST, WASO, SOL, sleep efficiency, and rest–activity rhythms
- Metabolic & obesity support activity, sedentary time, sleep quality, and circadian disruption
Enhanced for the scientist
- Purpose-made for remote data collection, the Empatica Health Monitoring Platform is FDA-cleared and developed to provide researchers with medical-grade data, collected continuously from participants’ homes
- Accelerate treatment research with over 300 clinically validated and research-grade digital biomarkers that can be used as digital endpoints in your trials
- Develop your own digital biomarkers using high-frequency raw data from the EmbracePlus sensors
- Visualize digital biomarkers and patient data inside the Care Portal, spotting patterns and adverse events
- Support eCOA and ePRO data collection strategies, providing continuous, sensor-derived measures for use in regulatory submissions
Powered by EmbracePlus
- The world’s most advanced and versatile medical device
- 5x powerful sensors: PPG, EDA, Skin Thermometer, Accelerometer and Gyroscope
- Fully adaptable to the needs of your study; balance power with battery consumption and data quality using preconfigured sensor modes, including Actigraphy modes
- Taking health monitoring beyond the wrist, EmbracePlus can be combined with different accessories such as a belt clip and an elastic strap to be worn across different areas of the body
EmbraceMini: The perfect actigraphy wearable
- Compact and discreet, ideal to be worn next to a favourite watch or accessory
- 4x sensors: Accelerometer, Gyroscope, Magnetometer, Ambient Light Sensor
- 14+ days of battery
- The smallest actigraphy wearable validated for clinical research
- Fully modular
Seamless study management through the Care Portal
Centralize wearable data, digital biomarkers, and compliance metrics in a secure, web-based platform, giving sponsors, CROs, and site teams audit-ready visibility across every participant, site, and geography throughout the study.
- Manage multiple studies and sites through a secure online portal
- Easily enroll and manage participants
- Visualize patient data and digital biomarkers across timeframes
- Wearing time reports and dashboards
Explore Care
The largest and most trusted selection of digital biomarkers in research
- Over 300 digital biomarkers, including dozens of sleep and activity measures
- 6 FDA-cleared measures
- Data visualization directly inside the Care Portal
- Algorithm integrations from trusted partners
Discover our range of digital biomarkers
Achieve multifaceted trial outcomes with double-device monitoring
Monitor each participant using 2x devices, in any form factor of your choice. Data flows into a single app installed on participants’ phones, ensuring the same, low-burden experience.
Build complementary datasets
Track vitals and other specialized digital biomarkers alongside actigraphy data, with 300+ digital measures to choose from.
Discover correlations
Reveal important correlations that single-device monitoring can miss with accurate and in-sync time-stamping.
Achieve more accuracy and versatility
Combine data collected from different body parts, such as lumbar and waist monitoring with wrist data.
Design more sophisticated protocols
Leverage the ability to capture different types of digital endpoints simultaneously, and demonstrate the reliability of your study.
Streamline clinical trials with Empatica’s Cloud API
Seamlessly integrate the Empatica Health Monitoring Platform into your existing clinical trial management system (CTMS) with our Cloud APIs.
- Reduce study complexities with seamless data flow
- Leverage Empatica’s 300+ digital measures and FDA-cleared medical wearable
- Manage EmbracePlus users directly from your own software
Learn more
Empatica Actigraphy
Explore a comprehensive range of sleep and activity endpoints used in clinical research, including TST, WASO, sleep efficiency, rest-activity rhythm, and circadian disruption indices, supporting sleep studies, fatigue endpoints, and actigraphy-based clinical outcome assessments in decentralized trials.
Learn more
Regulatory and Compliance
Empatica’s constant and decisive efforts aim at ensuring the safety, effectiveness, and quality of its medical devices as well as providing products that meet customer and applicable statutory and regulatory requirements
View Regulatory & Compliance
Thousands of papers have been published using our technology
We collaborate with the best research teams in the world to advance the understanding of human health in real-life settings. Our work is focused on measuring and quantifying the impact of wearable technology in health, while our products have been used in a breadth of contexts, from large-scale clinical trials to intimate academic studies.
Frequently Asked Questions
How does Empatica ensure regulatory compliance in clinical trials?
Empatica's platform is built to meet the regulatory standards required for use in sponsored clinical trials. EmbracePlus and EmbraceMini are FDA-cleared medical devices and CE MDR certified under EU Medical Device Regulation 2017/745. All data is stored and transmitted in compliance with 21 CFR Part 11, HIPAA, and GDPR. The platform generates complete audit trails, supports IRB and ethics committee submissions with purpose-built documentation packages, and undergoes regular independent quality audits. Empatica's regulatory team provides direct support throughout the submission process, including device validation documentation, protocol-specific IFU materials, and post-market surveillance reporting.
What therapeutic areas has Empatica's platform been used in?
Empatica's platform has been deployed across 120+ industry-sponsored trials in neurology (including epilepsy and seizure monitoring), CNS and psychiatry, oncology, rare disease, cardiovascular, sleep medicine, and pain and musculoskeletal conditions. In neurology, EmbracePlus carries FDA clearance for tonic-clonic seizure detection, one of only a handful of wearable devices with this clearance. In CNS and sleep research, EmbraceMini's actigraphy suite delivers the full set of sleep endpoints (TST, WASO, sleep efficiency) required by FDA and EMA guidance documents. Empatica's clinical team can advise on device selection, sensor configuration, and endpoint selection for your specific indication.
How long does it take to get started with Empatica for a new trial?
Empatica's average time from contract signing to first patient data collection is under two months, significantly faster than custom-built or multi-vendor solutions. The onboarding process includes protocol design support, device configuration to your sensor mode requirements, Care App localisation for your study languages, site training materials, and logistics setup for device shipping and returns. Empatica handles all hardware provisioning, including phone compatibility testing and provisioned phones if required by your protocol. For multi-site or global trials, the same onboarding workflow scales without requiring additional vendor integrations.
What makes Empatica's digital biomarkers suitable for regulatory submissions?
Empatica's digital biomarkers are derived from FDA-cleared hardware and validated against clinical gold standards across peer-reviewed publications. Six measures carry direct FDA clearance. The broader library of 300+ measures is research-grade and designed to meet the FDA's Digital Health Technology guidance framework and the V3 (Verification, Analytical Validation, Clinical Validation) framework for digital endpoint qualification. Empatica provides algorithm documentation, validation study references, and regulatory submission support materials, including device descriptions suitable for IND, NDA, and BLA filings, through its dedicated regulatory affairs team.
How does Empatica support patient compliance and data completeness?
Empatica's >90% compliance rate across actigraphy studies reflects deliberate device and UX design choices. EmbracePlus and EmbraceMini are lightweight, waterproof, and designed to be worn alongside everyday accessories. The Care App supports 40+ languages and is installable on all major Android and iOS smartphones, with an onboarding flow participants can complete independently. Battery life of up to 28 days (EmbracePlus) and 14+ days (EmbraceMini) minimises charging interruptions. Site staff receive automated adherence reports by email, enabling early intervention when compliance dips, and Empatica's help desk provides direct participant support across all geographies.
Can Empatica's devices be used across different body locations?
Yes. EmbracePlus supports multi-body monitoring through a modular accessory system, including a wrist strap, belt clip, and elastic strap, allowing lumbar, waist, and wrist placement in the same study. Two devices can be deployed per participant simultaneously, with all data flowing into a single Care App instance. This enables combined endpoint strategies, for example, pairing wrist-based PPG and EDA data with lumbar accelerometry for gait analysis, without increasing app complexity for the patient. EmbraceMini is optimised for wrist actigraphy and designed to be worn discreetly alongside a personal watch.
Wondering if our solutions and digital biomarkers fit your needs?
Reach out and a member of our team will be in touch with you as soon as possible.