For clinical trials
Cognition
Digital cognitive assessments with automated scoring for clinical trials, in the clinic or at home.
BioSensics supports cognitive assessments with BioDigit Cognition, from task selection to standardized digital administration, secure data handling, and automated scoring. Available tasks include verbal fluency, oral Symbol Digit Modalities Test (SDMT), trail making, digit span, go/no-go, and conflicting instructions. Assessment batteries, collection settings, and scoring methods are matched to your study objectives, with supporting evidence reviewed for each task.
$3M NIH award brings our digital cognitive assessments to the PSP Trial Platform
With a $3 million NIH award, BioSensics is integrating its digital health technologies, including BioDigit Cognition, into the Progressive Supranuclear Palsy Trial Platform (PTP), a multi-site trial evaluating candidate therapies under a shared protocol. This integration milestone is distinct from evidence validating individual cognitive measures for a specific trial use.
Bring standardized administration and automated scoring to cognitive assessments
Cognitive assessments characterize performance across domains such as attention, processing speed, memory, and executive function. Manual scoring and differences in administration can introduce variability between raters and sites. BioSensics supports standardized digital administration and task-specific automated scoring: protocol-configured assessments, secure data handling, and speech recognition or other analysis methods appropriate to each task. Scores may describe response accuracy, response times, or completion times. The evidence needed for a trial endpoint depends on the selected assessment, population, language, and administration setting; automated scoring alone does not establish comparability between clinic and home collection.
What your study receives
Examples of the measures available through this service. The final selection depends on the configured assessments and the study design.
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Response accuracy
Task-specific accuracy scores, such as correct responses and errors, for each configured assessment.
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Response and completion times
Response latencies and completion times for applicable tasks, supporting comparison of performance across scheduled visits.
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Verbal task scores
Scores for verbal fluency and other spoken-response tasks, derived with automated speech recognition where applicable. Audio recordings are encrypted and stored securely in the study environment.
Configured around your protocol
Support for administering, managing, and scoring cognitive assessments at study sites and at home.
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Cognitive task selection
Verbal fluency, oral SDMT, trail making, forward and backward digit span, go/no-go, and conflicting instruction tasks.
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Protocol-configured batteries
Modular assessment batteries and visit schedules tailored to the study's measurement objectives.
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Clinic and home administration
Collection through BioDigit Clinic or BioDigit Home, including remotely supervised visits, with the level of supervision and task instructions defined for each setting.
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Task-specific automated scoring
Speech recognition supports verbal-response scoring; accuracy and timing are captured for applicable tasks.
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Centralized study data
Responses, timings, and audio are encrypted and transferred to a central study environment for authorized study-team access as required.
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Longitudinal review
Study teams can review scored results and participant history across visits, with reports for downstream analysis.
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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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 assessment data, with applicable HIPAA and GDPR requirements reviewed for the study.
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Audit trail
Audit records support traceability of study-data activity and authorized review.
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Authorized access
Role-based access controls govern who can view, share, and review each assessment.
From protocol to results
A structured workflow takes each assessment from administration at the site or at home through secure upload, task-specific automated scoring, and reporting, with traceability of recorded study activities.
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Configure
Study-specific assessment batteries, users, sites, and visit schedules are configured before deployment.
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Administer
Site staff administer assessments in the clinic, or participants complete configured tasks at home, using the protocol-defined instructions and level of supervision for each assessment.
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Upload and score
Responses, timings, and audio transfer securely to the central study environment for speech recognition or other task-specific scoring. Quality review and exception handling follow the study requirements.
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Review and report
Study teams review scored results and participant history in one place to track changes across visits. Reports and exports include traceability records, with file formats, delivery timing, and integration needs defined in the study scope.
Service details
| Detail | Description |
|---|---|
| Service | End-to-end digital cognitive assessments, data management, and automated scoring for clinical trials |
| Assessments | Verbal fluency, oral SDMT, trail making, forward and backward digit span, go/no-go, conflicting instruction tasks, and other study-specific assessments |
| Cognitive domains | Processing speed, attention, working memory, executive function, and language |
| Settings | Clinic collection via BioDigit Clinic or home collection via BioDigit Home, including remotely supervised visits; administration requirements and supporting evidence are specific to the task and setting |
| Languages | Supported task-language combinations and the related evidence are confirmed for the study population; spoken-response tasks depend on speech recognition support for each language |
| Analysis method | Automated speech recognition for applicable verbal responses; task-specific capture and analysis of response accuracy, response times, and completion times |
| Scoring | Automated scoring for configured tasks, with quality-review and exception-handling requirements defined for the study; clinic-to-home comparability requires assessment-specific evidence |
| Upload and storage | Centralized upload and storage in the configured study environment; confirm data-access arrangements, API availability, and integration requirements |
| Reporting | Study reports with participant history for longitudinal review and traceability records for recorded study activities |
| Validation | Review platform validation for the software version and configuration separately from measurement evidence for the intended use |
| Regulatory | Review applicable quality and security certification scope, electronic-record controls, and privacy requirements, including ISO 13485, ISO 27001, 21 CFR Part 11, EU Annex 11, HIPAA, and GDPR |
| Development | Developed with the support of the National Institutes of Health (NIH) |
| Support | Study configuration, training, deployment support, and ongoing assistance |
The tools behind the service
Cognitive assessments can run alongside other digital assessments within a configured BioSensics study workflow, with centralized access to the selected study data.
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Cognitive assessments
BioDigit Cognition
Software for administering digital cognitive assessments and applying automated, task-specific scoring to captured responses.
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In-clinic assessment
BioDigit Clinic
Capture cognitive assessments alongside speech, video, and fine motor control assessments at clinical sites in one system.
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At-home monitoring
BioDigit Home
Remote and remotely supervised cognitive assessments at home, with administration and scoring requirements defined for the selected tasks.
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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.
Does automated scoring remove the need for manual review?
Automated scoring applies the method configured for each task. Incomplete tasks, poor-quality recordings, or uncertain speech recognition may require manual review. Quality-review and exception-handling procedures are defined for the study.
Are clinic and home results interchangeable?
Not by default. Using the same task and scoring method does not by itself establish comparability. The evidence and protocol requirements for the planned setting, level of supervision, device, and participant population are confirmed for each assessment.
How are tasks selected for a trial?
Start from the cognitive domains and study objectives, then confirm task availability, language support, participant burden, scoring outputs, and the evidence supporting the intended endpoint role.
Can cognitive assessments be combined with other digital measures?
Yes. BioDigit Clinic and BioDigit Home run cognitive assessments alongside speech, video, and fine motor assessments in one study workflow. The proposed combination and visit schedule are confirmed during study planning.
How are data accessed and delivered?
Responses, timings, recordings, and scored results are stored in the configured study environment for authorized study-team access. Data-access arrangements, API availability, export formats, and report timing are defined in the study scope.
Related endpoints
Cognitive assessments are often paired with other digital measures collected in the same study.
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Speech and Voice
Measures of how a participant speaks, captured on the same platform and distinct from cognitive task scores.
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Gait and Balance
Instrumented gait and balance measures that are often collected alongside cognitive assessments in the same study.
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Patient-Reported Outcomes
The participant's own report of symptoms and function, adding their perspective to cognitive performance measures.
Bring digital cognitive assessments to your trial
Discuss cognitive tasks, administration settings, scoring methods, supporting evidence, and data delivery for your clinical trial with BioSensics.