For clinical trials
Fall Monitoring
Wearable fall-event monitoring for clinical trials, with sensor data and reported context collected at home and in the community.
BioSensics combines PAMSys Fall sensors with BioDigit Home fall diaries, multilingual participant and caregiver workflows, wear-time monitoring, secure data handling, and automated event detection. Timestamped sensor events include activity and posture data; participant and caregiver reports add fall circumstances and near-falls. Monitoring periods, diary schedules, event definitions, event review, valid-wear criteria, and missing-data procedures are defined for your study.
Fall monitoring experience in clinical trials and research
PAMSys Fall has been used to measure fall frequency in Phase 1 to 3 drug trials. Its product page includes selected publications and presentations. Review detection performance, false detections, missed events, and monitoring coverage for the intended population and endpoint role; deployment experience is distinct from validation for a particular study.
Complement reported falls with timestamped sensor data
Falls can be an important outcome in neurological and neuromuscular trials. Events occur between visits, so wearable monitoring and reported information provide complementary perspectives. BioSensics supports the workflow from device deployment to automated analysis: study-configured sensors, participant onboarding, wear-time monitoring, fall diaries, secure data handling, and automated detection with PAMSys Fall. Sensor-detected events remain distinct from reported context and near-falls. Define event review, valid-wear criteria, and handling of false detections, missed events, and incomplete reports for the study.
What your study receives
Examples of the data and measures available through this service. The final selection depends on the configured monitoring, diaries, and the study design.
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Sensor-detected fall events
Timestamped events with associated activity and posture data, with study-defined review distinguishing detected events from the fall records used in analysis.
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Reported fall context
Fall circumstances and near-falls reported through BioDigit Home diaries, with participant and caregiver reports labeled by source.
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Mobility measures and coverage
Walking bouts, steps, cadence, bout duration, step-duration variability, posture, and postural transitions from the same sensor, with estimated wear and nonwear periods for coverage review.
Configured around your protocol
Support from sensor deployment through data analysis for continuous fall monitoring at study sites and at home.
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Study-configured sensors
PAMSys Fall wearable sensors configured for the protocol, with wireless charging for extended monitoring.
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Automated fall detection
Automated algorithms identify and timestamp sensor-detected fall events during everyday wear and record associated activity and posture data, with event confirmation and review following study-specified procedures.
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Complementary mobility measures
Walking bouts, steps, cadence, bout duration, step-duration variability, posture, and postural transitions provide complementary mobility information from the same sensor.
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Sensor-integrated fall diaries
Fall circumstances and near-falls are reported through electronic diaries in BioDigit Home, with participant and caregiver reports labeled by source and linked to sensor events as defined for the study.
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Wear-time monitoring
Algorithm-derived wear-time information identifies potential nonwear periods for coverage review.
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Centralized data and reporting
BioDigit Cloud brings detected events, reported context, mobility measures, and wear-time information into one study environment for review and study-defined fall summaries and reports.
Built for regulated clinical research
The service combines controlled data access, security, and traceability to support regulated clinical research. Study-specific requirements and applicable documentation should be reviewed before deployment.
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Device regulatory documentation
Review applicable CE-marking documentation and UK registration for the PAMSys Fall device version, intended use, and deployment locations.
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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
Review how configured electronic records and signatures support applicable 21 CFR Part 11 and EU Annex 11 requirements.
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Quality and information security
Quality and information-security controls support study operations. Confirm current ISO 13485 and ISO 27001 certification status and applicable scope.
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HIPAA and GDPR
Privacy and security controls support the handling of 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 setup, monitoring, upload, automated analysis, and reporting, with traceable records of study-data activity.
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Configure
Study-specific monitoring periods, diary schedules, respondent roles, language versions, users, event definitions, and review procedures are configured before deployment.
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Deploy
Sensors are provided at the study site or shipped to the home, as agreed for the study, with participant- and caregiver-facing guidance in the language versions selected for the protocol.
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Monitor and upload
Participants wear the sensor as specified in the protocol to record event, activity, posture, and wear-time data. Participant or caregiver diaries add context through BioDigit Home. Monitoring data transfer securely to BioDigit Cloud through the configured upload workflow.
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Analyze and report
Algorithms identify timestamped sensor events, characterize associated activity and posture, and compute configured mobility measures, with study-defined review distinguishing detected events from the fall records used in analysis. Study teams review sensor-detected events, reported context, and wear-time information centrally; reports, exports, API access, and activity records are defined in the study scope.
Service details
| Service element | Details |
|---|---|
| Service | End-to-end fall monitoring, device management, data management, and automated analysis for clinical trials |
| Capture | Study-configured PAMSys Fall wearable sensors worn during protocol-defined monitoring at home and in the community |
| Sensor | Single lightweight wearable with a 3D accelerometer; confirm the specified 50 Hz sampling configuration for the selected device version |
| Fall detection | Automated identification of sensor-detected fall events with timestamps and associated activity data. Event-confirmation procedures and any separate fall-risk model require study-specific definition and evidence |
| Co-monitored measures | Physical activity, walking and running parameters (walking bouts, step counts, cadence, bout duration, and step-duration variability), posture, and postural transitions from the same device |
| Fall context | Fall circumstances and near-falls reported through BioDigit Home diaries, with participant and caregiver reports labeled by source. Their relationship to sensor-detected events is defined for the study |
| Monitoring mode | Continuous recording during planned wear; upload and review timing depend on configuration. Research monitoring does not imply immediate safety alerts or emergency response |
| Battery and charging | Wireless charging; battery duration and charging intervals depend on the device version and monitoring configuration |
| Wear-time monitoring | Estimated wear and nonwear periods support coverage review. Define valid monitoring time and handling of missing periods when analyzing fall frequency |
| Languages | Multilingual participant- and caregiver-facing workflows; confirm available language versions, diary translations, and technical-support coverage for the study |
| Upload and storage | Centralized upload and storage through BioDigit Cloud; access, exports, and API requirements are defined for the study. Any proposed BioDigit Database contribution is considered separately |
| Reporting | Centralized review of detected events, reported context, mobility measures, and wear-time information; study-defined fall summaries, reports, and exports |
| Regulatory | Confirm device-specific CE-marking documentation, UK registration, quality and information-security certification scope, electronic-record controls, and applicable privacy requirements for the deployment |
| Support | Study configuration, training, deployment support, and ongoing assistance |
The tools behind the service
Fall monitoring integrates with BioSensics' full platform. Deploy alongside other digital assessments within the same study protocol, with all data accessible through a single portal.
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Fall monitoring
PAMSys Fall
The wearable sensor and algorithms for detecting and characterizing sensor-derived fall events during everyday research monitoring.
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Activity monitoring
PAMSys
Wearable sensor for continuous monitoring of body posture, postural transitions, and walking parameters.
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At-home monitoring
BioDigit Home
Remote collection of speech, video, cognitive, and participant-reported assessments at home, including diary context that can be reviewed alongside sensor-detected events.
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Research data
BioDigit Database
A research resource for disease-specific digital biomarkers. 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.
Does the sensor alert anyone when a fall is detected?
No. Research monitoring does not imply immediate safety alerts or emergency response; upload, analysis, and staff-review timing are defined by the study configuration, and participants and caregivers follow the study's own guidance.
Are detected events the same as confirmed falls?
No. Sensor-detected events remain distinct from reported context and near-falls, and study-defined review distinguishes detected events from the fall records used in analysis; handling of false detections, missed events, and incomplete reports is defined for the study.
Can the mobility measures predict falls?
The walking, posture, and transition measures from the same sensor provide complementary mobility information but do not by themselves constitute a validated fall-risk prediction; any separate fall-risk model requires study-specific definition and evidence.
How is missing monitoring time handled?
Missing monitoring periods are not treated as zero falls. Wear-time information identifies potential nonwear periods, and valid monitoring time, handling of missing periods, and events reported during nonwear are defined for the study before fall frequency is analyzed.
How are data accessed and delivered?
Detected events, reported context, mobility measures, and wear-time information are stored in BioDigit Cloud for authorized study-team access. Fall summaries, reports, exports, and API access are defined for the study; any proposed BioDigit Database contribution is considered separately.
Related endpoints
Fall monitoring is often paired with other digital measures collected in the same study.
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Ambulation and Physical Activity
Continuous walking, posture, and activity monitoring with the PAMSys pendant and ankle sensors.
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Gait and Balance
Instrumented gait and balance tests at visits, complementing everyday fall and mobility monitoring.
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Patient-Reported Outcomes
Participant questionnaires and electronic diaries, including the fall diaries used alongside sensor-detected events.
Bring longitudinal fall monitoring to your trial
Discuss event definitions, monitoring coverage, review procedures, supporting evidence, and data-delivery requirements for your clinical trial with BioSensics.