For clinical trials
Patient-Reported Outcomes
Participant questionnaires and electronic diaries for clinical trials, at home and on site.
BioSensics captures participants' own reports of symptoms and daily functioning through study-configured questionnaires and electronic diaries. Scheduled prompts, checks at entry, scoring where configured, and secure transfer to BioDigit Cloud support collection at home and on site. Electronic patient-reported outcomes (ePRO) form part of the broader electronic clinical outcome assessment (eCOA) platform, alongside wearable, speech, video, cognitive, and motor assessments. Instruments, schedules, languages, and settings are selected for your study, with permissions and supporting evidence confirmed for each instrument.
Selected by the NIH to develop remote measurement technologies for rare-disease trials
In 2022, the U.S. National Institutes of Health selected BioSensics to develop remote measurement technologies for rare-disease clinical trials. BioDigit Home supports participant-reported questionnaires and diaries alongside wearable, speech, video, and cognitive assessments on the study device. This development milestone does not establish the validity of each instrument or endpoint.
Bring the participant perspective into your measurement strategy
Patient-reported outcomes capture participants' own accounts of their condition, symptoms, and daily functioning, without interpretation by clinicians or others. They complement clinician-reported and performance-based measures within the broader eCOA framework. BioSensics supports the workflow from protocol configuration through data capture and scoring where applicable: questionnaires and diaries on the study device, scheduled prompts, point-of-entry checks, and secure transfer to BioDigit Cloud. Staff may assist as permitted by the instrument and protocol, while preserving the participant's own responses. Digital collection supports timely, timestamped records; suitability for a trial endpoint depends on the selected instrument and intended use.
What your study receives
Examples of the data available through this service. The final selection depends on the configured instruments and the study design.
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Questionnaire responses
Timestamped participant responses to the instruments selected for the study.
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Electronic diary entries
Between-visit records, such as medication use or falls, collected on the protocol schedule.
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Configured scores
Instrument scores where automated scoring is configured, with point-of-entry flags and timestamped completion records available for study-team review.
Configured around your protocol
An end-to-end service for configuring, collecting, and reviewing participant-reported data at home and on site, with scoring where applicable.
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Protocol-specific instruments
Protocol-selected ePRO questionnaires and diaries, with study schedules and workflows configured for the authorized instrument versions.
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Electronic diaries
Protocol-configured electronic diaries for between-visit entries, including medication and fall diaries.
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At-home and on-site collection
Participant responses are collected at home through BioDigit Home or at sites through BioDigit Clinic, using instrument versions and administration procedures appropriate to each setting.
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Scheduled prompts
Automated reminders and scheduled tasks support timely questionnaire and diary completion in line with the protocol schedule.
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Automated scoring and quality checks
Automated algorithms calculate scores for instruments with configured scoring. Checks at entry can flag incomplete or out-of-range responses.
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Multilingual delivery and support
BioDigit Home supports 20+ languages, with remote technical support for sites and participants; instrument translations, on-site language options, and support languages are confirmed for the study.
Built for regulated clinical research
Quality, security, privacy, and traceability controls support regulated clinical research. Applicable documentation, instrument requirements, and study-specific configurations should be reviewed before deployment.
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ISO 13485 quality system
Quality management supports software development and maintenance. Review current ISO 13485 certification status and the scope applicable to the study platform.
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21 CFR Part 11 support
Controls are designed to support applicable 21 CFR Part 11 requirements for electronic records and electronic signatures.
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FDA guidance and ICH GCP
Designed to support study workflows aligned with applicable FDA guidance and ICH Good Clinical Practice principles.
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HIPAA safeguards
Designed to support the secure handling of protected health information in accordance with applicable HIPAA requirements.
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GDPR safeguards
Privacy controls support personal-data processing, with applicable GDPR requirements and study-specific responsibilities reviewed for the deployment.
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Security controls
Security controls support the secure collection, transfer, and storage of study data.
From protocol to results
A defined workflow moves each instrument through configuration, completion, scoring where applicable, and review, with traceability of recorded study activities.
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Configure
Instruments, diaries, schedules, language versions, respondent roles, and scoring requirements are configured, with instrument permissions and any requirements for electronic administration confirmed before deployment.
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Prompt and complete
Scheduled tasks and automated reminders prompt participants when entries are due. Participants enter their own responses at home or during site visits, with assistance only as permitted by the instrument and protocol.
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Check and score
Checks at entry flag incomplete or out-of-range responses before submission. Automated algorithms score instruments where configured; unscored diary entries remain available as study data. Exception handling is defined for the study.
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Review
Study teams review timestamped completion records and data in BioDigit Cloud, with traceability of recorded changes. Required exports, metadata, and delivery schedules are defined for the study.
Service details
| Detail | Description |
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| Service | Protocol-configured ePRO questionnaires and electronic diaries within a broader eCOA platform, with scoring where applicable and study-data management |
| Instruments | Protocol-selected questionnaires and diaries, configured using authorized instrument and language versions with study-specific schedules and workflows; instrument availability, licensing, and permitted electronic adaptations are confirmed for the study |
| Diaries | Electronic diaries for between-visit entries, including medication and fall diaries |
| Settings | At-home completion through BioDigit Home and on-site completion through BioDigit Clinic |
| Devices | A configured study device can bring ePROs, diaries, and other protocol assessments into one participant workflow |
| Scoring | Automated scoring where configured and applicable; point-of-entry checks can flag incomplete or out-of-range responses |
| Adherence | Scheduled tasks and reminders that support timely completion in line with the protocol |
| Languages | BioDigit Home supports 20+ languages; instrument translations, their provenance and permissions, on-site language options, and technical-support coverage are confirmed separately |
| Telehealth | Support for telehealth visits with study staff, when included in the study workflow |
| Participant support | Remote technical support for study sites and participants |
| Upload and storage | Data are securely transmitted to BioDigit Cloud for storage and remote access |
| Regulatory | Quality-system documentation and controls supporting applicable electronic-record, privacy, and security requirements; review ISO 13485 scope, 21 CFR Part 11, HIPAA, GDPR, relevant FDA guidance, and ICH GCP for the study |
| Support | Study configuration, training, deployment support, and ongoing operational assistance |
The tools behind the service
Patient-reported outcomes can be integrated alongside wearable, speech, video, cognitive, and motor assessments, with study data accessible through a single portal.
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At-home collection
BioDigit Home
A participant-facing study device for at-home ePROs and diaries, alongside wearable, speech, video, and cognitive assessments.
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In-clinic collection
BioDigit Clinic
On-site eCOA and other assessments in a connected study workflow, with automated scoring where configured.
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Smartwatch capture
BioDigit Watch
Optional smartwatch data collection alongside questionnaires, diaries, and other protocol assessments within the configured study platform.
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Research data
BioDigit Database
A research resource for disease-specific digital biomarkers. Discuss access and any proposed study-data contribution separately, including permissions, consent, and permitted uses.
Questions to resolve before deployment
Key considerations for selecting assessments, interpreting results, and planning data delivery.
How does ePRO relate to eCOA?
eCOA is the broader category of electronically collected clinical outcome assessments, including clinician-reported, observer-reported, and performance outcomes. This service covers participants' own reports through ePRO questionnaires and diaries; clinician- or observer-reported instruments are identified separately.
Can site staff complete an ePRO for a participant?
No. An ePRO represents the participant's own response, not a staff member's interpretation. Permitted administration assistance is specified per instrument and protocol, and point-of-entry checks flag incomplete or out-of-range entries without interpreting or replacing the participant's responses.
Are instruments and translations included?
Instrument versions, licensing, translation permissions, and configuration responsibilities are confirmed during study planning; platform language availability does not establish availability of every instrument translation. Electronic administration may also require the instrument owner's permission and evidence of measurement equivalence for the intended use.
Can questionnaires run alongside other assessments?
Yes. Questionnaires and diaries run on the same study device as wearable, speech, video, cognitive, and motor assessments within one protocol, with device configuration, assessment schedules, and participant burden confirmed for the proposed combination.
How are data accessed and delivered?
Responses, scores, and completion records are transmitted to BioDigit Cloud for storage and authorized remote access, with traceability of completion and data changes. Required exports, metadata, and delivery schedules are defined for the study.
Related endpoints
Patient-reported outcomes are often paired with performance and sensor measures collected in the same study.
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Cognition
Performance-based cognitive assessments to pair with participant reports, on the same study device.
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Gait and Balance
Structured mobility assessments to combine with reported symptoms and diary entries.
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Fall Monitoring
Wearable fall detection and monitoring between visits, complementing fall diaries with sensor-based records.
Bring participant-reported data into your connected study workflow
Discuss participant-reported questionnaires and diaries, instrument requirements, language versions, and data delivery for your clinical trial with BioSensics.