For clinical trials
Physiological Monitoring
Physiological and movement data from compatible smartwatches, with signals and recording schedules selected for your clinical trial.
BioSensics configures compatible commercial smartwatches for remote monitoring through BioDigit Watch, with secure cellular transfer and centralized data access in BioDigit Cloud. Supported signals include accelerometer, photoplethysmography (PPG), heart rate, SpO2, and skin temperature data, depending on the selected watch and configuration. Sensors, recording schedules, analysis, and supporting evidence are matched to your study objectives. Participants use a preconfigured watch without a companion smartphone app, smartphone pairing, or separate device account.
Remote monitoring without smartphone pairing
Preconfigured smartwatches can ship directly to participants and transfer supported sensor data over built-in LTE where service and coverage are available. No companion smartphone app or separate device account is required; study instructions guide wear and charging.
Extend physiological measurement into daily life
Measurements collected between visits can add context to assessments made in the clinic. BioSensics supports the workflow from smartwatch deployment through data review and analysis, using compatible commercial devices configured for the study. BioDigit Watch records supported physiological and movement signals and transfers data securely to BioDigit Cloud. Available signals, recording modes, and derived measures depend on the selected watch, software, and protocol. Supporting evidence is reviewed for the intended population and endpoint use.
What your study receives
Examples of the data and measures available through this service. The final selection depends on the configured sensors, schedules, and the study design.
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Physiological measures
Heart rate and pulse-derived variability measures from suitable PPG recordings, with SpO2 and skin temperature where supported. Additional cardiovascular measures and evidence for their intended use are defined for the study.
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Activity and movement measures
Raw accelerometer data and supported activity measures, such as step count, active minutes, and sedentary time, from the same device.
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Raw signals and derived measures
Recorded sensor data and study-selected derived measures, with reports and API access defined in the study scope. Analysis methods and supporting evidence are reviewed for the intended use.
Configured around your protocol
Support from smartwatch deployment through data review and analysis, with recording schedules and remote-monitoring workflows configured for your trial.
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Study-configured smartwatches
Compatible smartwatches configured with the sensors, sampling rates, and recording schedules supported by the selected device, and shipped directly to participants with study instructions.
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Heart rate and pulse variability
Optical pulse (PPG) recordings support heart rate and pulse rate variability analysis. PPG-derived HRV estimates require suitable signal quality and validation for the intended study use.
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SpO2 and skin temperature
Blood oxygen saturation (SpO2) and skin temperature can be collected where supported by the watch, software, and recording configuration.
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Co-monitored activity and movement
Accelerometer data and supported activity measures, including step count, active minutes, and sedentary time, provide movement context alongside physiological recordings.
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Built-in LTE data transfer
Supported sensor data transfer securely over built-in LTE where service and coverage are available. On-device buffering supports automatic synchronization when connectivity returns.
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Centralized data and analysis
Data are encrypted on the device and uploaded to BioDigit Cloud for authorized study-team access. Analysis methods, derived measures, and API requirements are defined for the study.
Built for regulated clinical research
On-device encryption, controlled access, security, and traceability support clinical research. Platform documentation and study-specific requirements are reviewed for the selected deployment.
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Encrypted on the device
Data are encrypted on the watch and transferred securely to BioDigit Cloud, with applicable privacy requirements reviewed for the study.
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Platform validation
Cloud-based study-data collection and management, with validation documentation reviewed for the software version, intended use, and configuration.
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21 CFR Part 11 and Annex 11
Electronic-record controls are assessed against applicable 21 CFR Part 11 and EU Annex 11 requirements for the configured system and study workflow.
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Quality and information security
BioSensics maintains an ISO 13485-certified quality management system. Information-security controls support the protection of study data.
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HIPAA and GDPR
Privacy and security controls support participant monitoring data, with applicable HIPAA and GDPR requirements reviewed for the study.
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Audit trail and authorized access
Audit records support traceability of study-data activity, with role-based access controls governing who can view and share results.
From protocol to results
A structured workflow connects study configuration, device deployment, monitoring, upload, analysis, and reporting, with traceable records of study-data activity.
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Configure
Sensor selection, sampling rates, collection schedules, monitoring periods, users, and workflows are configured to the protocol before deployment.
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Deploy
Preconfigured watches are shipped directly to participants or provided at the study site, with no companion smartphone app or separate device account. Study instructions guide wear and charging.
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Monitor and upload
Participants wear and charge the watch as instructed. Supported accelerometer, PPG, heart rate, SpO2, and skin temperature signals are recorded according to the study configuration and transferred securely to BioDigit Cloud over built-in LTE when connectivity is available. On-device buffering supports automatic synchronization.
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Analyze and report
Analysis of suitable recordings can derive pulse variability and other study-selected cardiovascular measures from PPG, and activity measures from accelerometer data. Study teams review available signals and derived measures in BioDigit Cloud. Quality review, supporting evidence, reports, raw-data delivery, and API access are defined for the study.
Service details
| Service element | Details |
|---|---|
| Service | End-to-end physiological monitoring, device management, data management, and automated analysis for clinical trials |
| Capture | Compatible commercial smartwatches running BioDigit Watch, worn during protocol-defined monitoring at home and in the community |
| Compatible devices | Supported Samsung Galaxy Watch models; device selection depends on required signals, software, and cellular availability |
| Data streams | Accelerometer, photoplethysmography (PPG), heart rate, SpO2, and skin temperature data, depending on the selected watch, software, and recording configuration |
| Physiological measures | Heart rate and pulse rate variability from suitable PPG recordings; PPG-derived HRV estimates and additional cardiovascular measures require evidence for the intended use. SpO2 and skin temperature where supported |
| Co-monitored measures | Raw accelerometer data and supported activity measures, such as step count, active minutes, and sedentary time, from the same device |
| Sampling and schedules | Sensor selection, sampling rates, and recording schedules configurable within the limits of the selected sensor, device, and supported software |
| Monitoring mode | Continuous or scheduled recording, depending on the signal, supported device capabilities, and study configuration |
| Data transmission | Built-in LTE where service and coverage are available, with no smartphone pairing required; data buffered on the device and synced automatically when connectivity is available |
| Battery and charging | Up to 3 days between charges, depending on the watch, recording configuration, connectivity, and use |
| Participant setup | No companion smartphone app, smartphone pairing, or separate device account required; study enrollment and consent follow the trial protocol |
| Data output | Recorded sensor data and study-selected derived measures; analysis methods, supporting evidence, and raw-data delivery defined for the study |
| Upload and storage | On-device encryption with centralized upload and storage in BioDigit Cloud; authorized access, API requirements, and data-protection responsibilities defined for the study. Any proposed BioDigit Database contribution is considered separately |
| Reporting | Centralized review of physiological and activity measures through a single secure portal, with study reports and export for downstream analysis |
| Regulatory | ISO 13485 quality management; electronic-record controls assessed against applicable 21 CFR Part 11 and EU Annex 11 requirements; privacy and security controls supporting applicable HIPAA and GDPR requirements |
| Support | Study configuration, training, deployment support, and ongoing assistance |
The tools behind the service
Physiological monitoring can run alongside other BioSensics digital assessments within one protocol, with supported study data accessible through BioDigit Cloud.
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Smartwatch monitoring
BioDigit Watch
Software that configures compatible smartwatches for study-specific recording of supported motion and physiological signals, with secure transfer to BioDigit Cloud.
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Activity monitoring
PAMSys
Pendant sensor for monitoring body posture, postural transitions, physical activity, and walking parameters, deployable alongside the smartwatch in one protocol.
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At-home monitoring
BioDigit Home
Remote collection of speech, video, cognitive, and patient-reported assessments from participants at home on a single study device.
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Research data
BioDigit Database
A research resource for disease-specific digital biomarker data. Access and any proposed study-data contribution are considered separately, including permissions, consent, and permitted uses.
Questions to resolve before deployment
Key considerations for selecting assessments, interpreting results, and planning data delivery.
Do participants need a smartphone or an app?
No companion smartphone app or smartphone pairing is required. Preconfigured watches transfer data over built-in LTE where service and coverage are available. Participants follow the study instructions for wear and charging; battery life is up to 3 days depending on the watch, recording configuration, connectivity, and use.
How much of the day is covered?
Coverage depends on the selected signals, recording schedules, wear, and charging. Data are buffered on the device and synced automatically when connectivity is available. Wear expectations, usable-data criteria, and missing-data handling are defined during study planning.
Which devices are supported?
Supported Samsung Galaxy Watch models, selected according to the required signals, software, and cellular availability. Sensor selection, sampling rates, and recording schedules are configurable within supported device and software limits.
Are the measures validated for my endpoint?
The evidence for each proposed measure, population, and endpoint role is reviewed during study planning. Platform validation is assessed separately from measurement validation. Analysis methods, signal-quality requirements, and raw-data access for custom analysis are defined in the study scope.
How are data accessed and delivered?
Recorded signals and processed measures are stored in BioDigit Cloud for authorized study-team access. Reports, exports, API access, delivery formats, and timing are defined in the study scope. Any proposed BioDigit Database contribution is considered separately, including permissions and permitted uses.
Related endpoints
Physiological monitoring is often paired with other digital measures collected in the same study.
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Ambulation and Physical Activity
Continuous monitoring of everyday walking, posture, and physical activity with PAMSys wearables, deployable alongside the smartwatch in one protocol.
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Fall Monitoring
Fall detection and monitoring with the PAMSys Fall wearable between visits.
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Patient-Reported Outcomes
The participant's own report of symptoms and function, adding their perspective to physiological measurements.
Bring physiological monitoring into your clinical trial
Discuss sensors, collection schedules, monitoring periods, planned measures, supporting evidence, and data delivery for your clinical trial with BioSensics.