For clinical trials

Speech and Voice

Standardized speech collection, vocal-feature analysis, and centralized review for clinical trials.

BioSensics supports speech assessment from standardized tasks and multilingual collection through secure storage, BioDigit Speech analysis, and expert scoring and review where included. Tasks include passage reading, vowel phonation, counting, and syllable repetition, collected at sites or at home. Tasks, languages, recording requirements, and analysis features are selected for your study objectives, with supporting evidence reviewed for each task.

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Letter of Intent for digital speech measures in PSP accepted for review under the FDA ISTAND program

The FDA ISTAND program has accepted for review a Letter of Intent proposing BioDigit Speech automated speech measures as a drug development tool for PSP clinical trials.

View the qualification pathway

Objective voice biomarkers, captured and analyzed end to end

Speech assessments can provide information relevant to neuromotor and cognitive research, but consistent collection across sites and languages requires defined tasks and procedures. BioSensics supports speech collection, centralized review, and automated analysis: multilingual tasks, secure data handling, and BioDigit Speech feature extraction. Expert ratings, where included, are separate outputs. The features available for a recording depend on its task, language, and quality; supporting evidence should match the intended study use.

What your study receives

Examples of the data and measures available through this service. The final selection depends on the configured tasks and the study design.

  • Recordings and study metadata

    Speech recordings paired with structured study information collected through customizable e-forms.

  • Vocal-feature data

    Vocal features spanning phonation, articulation, prosody, and intelligibility; the features generated depend on the task, language, and recording quality.

  • Review and reporting

    Centralized access for expert scoring and review where the study includes it, with reports of the configured analysis results and activity records.

Analytical validation in PSP

In 49 participants with PSP, BioDigit Speech intelligibility scores from standardized passage reading were compared with the mean ratings of three experts. For native speakers, r = 0.90 and ICC = 0.84; automated scores were systematically lower.

Configured around your protocol

Support for capturing, managing, reviewing, and analyzing speech across study sites and languages, with secure cloud-based data management.

  • Protocol-defined speech tasks

    Study-specific, modular tasks including passage reading, vowel phonation, counting, and syllable repetition.

  • Multilingual collection

    Standardized speech collection used in clinical trials in more than 10 languages. Analysis coverage is task- and language-dependent.

  • Site and home capture

    Collection at clinical sites through BioDigit Clinic or remotely through BioDigit Home, including remotely supervised sessions, with recording procedures defined for each setting.

  • Recordings with context

    Recordings upload securely to the central study environment in BioDigit Cloud, paired with protocol-defined study metadata collected through customizable e-forms.

  • Automated feature extraction

    BioDigit Speech offers over 40 vocal features across its analysis capabilities; the features generated depend on the speech task, language, and recording quality.

  • Expert scoring and review

    Authorized expert raters and collaborators can access recordings for study-defined scoring and review.

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.

  • Platform validation

    Cloud-based study-data collection and management, with validation documentation reviewed for the software version, intended use, and configuration.

  • 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.

  • Quality and information security

    Quality and information-security controls support study operations. Confirm current ISO 13485 and ISO 27001 certification status and applicable scope.

  • HIPAA and GDPR

    Privacy and security controls support the handling of participant voice data, with applicable HIPAA and GDPR requirements reviewed for the study.

  • Audit trail

    Audit records support traceability of study-data activity and authorized review.

  • Authorized access

    Role-based access controls govern who can view, share, and review each recording.

Speech collection used in clinical trials in more than 10 languages

Standardized tasks and collection procedures across study languages and sites, with analysis coverage confirmed task by task. Expert scoring and review are included where specified by the study.

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From protocol to results

A defined workflow takes speech assessments from recording at a site or at home through upload, study-specified review, automated analysis, and reporting, with traceability of study-data activity.

  • Configure

    Tasks, languages, recording requirements, planned features, e-form fields, and the role of expert rating are configured before deployment.

  • Record and upload

    Site staff or participants record standardized speech tasks, in clinic or at home. Recordings and protocol-defined metadata are uploaded securely to the central study environment in BioDigit Cloud.

  • Review and analyze

    Authorized expert raters and collaborators review recordings where required by the protocol. BioDigit Speech analyzes eligible recordings to extract the vocal features selected for the task and language.

  • Report

    Configured results support study reports, with activity records providing traceability. Handling of unsuitable or incomplete recordings, reporting, export, and review responsibilities are defined in the study scope.

Service details

Service details
Detail Description
Service End-to-end voice capture, management, review, and automated analysis for clinical trials
Speech tasks Study-specific, modular tasks including passage reading, vowel phonation, counting, and syllable repetition
Languages Speech collection used in clinical trials in more than 10 languages; confirm the current language list, task-specific analysis coverage, and evidence relevant to the study
Settings In-clinic and remote collection across global study sites, including remotely supervised home sessions where configured
Upload and storage Centralized voice-data upload and storage through BioDigit Cloud, with study-specific access and data-delivery arrangements
Review Authorized expert scoring and review, distinct from automated feature extraction; rater provision and review responsibilities are specified in the study scope
Metadata Customizable e-forms for recording-associated study metadata; define required fields, user roles, and completion timing
Automated analysis Over 40 vocal features across BioDigit Speech capabilities, spanning phonation, articulation, prosody, and intelligibility; available outputs depend on the task, language, and recording quality
Audit and reporting Study-defined reports and activity records supporting traceability of study-data handling
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
Support Study configuration, training, deployment support, and ongoing assistance

The tools behind the service

Speech assessments can run alongside other digital assessments within a configured BioSensics study workflow, with centralized access to the selected study data.

  • Speech assessment

    BioDigit Speech

    BioDigit Speech extracts configured vocal features from eligible recordings. Its feature inventory spans over 40 measures; not every feature applies to every task or language.

  • In-clinic assessment

    BioDigit Clinic

    Capture speech alongside video, cognitive, and fine motor control assessments at clinical sites in one system.

  • At-home monitoring

    BioDigit Home

    Capture speech assessments at home through remote and remotely supervised study workflows.

  • 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 analysis replace expert rating?

Automated analysis extracts the configured vocal features, while expert raters provide separate scores or review where included. The outputs required by the protocol and the role of human review are confirmed during study planning; one does not automatically replace the other.

Are the same features available in every language?

Not always. Collection is standardized across languages, but analysis coverage is task- and language-dependent. Task and feature availability, and the supporting evidence, are confirmed for each study language before measures are selected.

Will every recording produce analysis results?

Not every recording is eligible for every analysis. Recording requirements, quality-review responsibilities, and the handling of incomplete or unsuitable recordings are defined during study planning.

How does speech analysis differ from cognitive testing?

Speech analysis extracts vocal features such as phonation, articulation, and prosody. Cognitive assessments measure performance on tasks, some of which use verbal responses. The study objectives determine which measures are needed, and both assessments can be included in the same protocol.

How are data accessed and delivered?

Recordings, study metadata, vocal-feature outputs, expert ratings where included, and reports are stored in the study environment in BioDigit Cloud for authorized study-team access. Data-access arrangements, API availability, export formats, and report timing are defined in the study scope.

Related endpoints

Speech assessment is often paired with other digital measures collected in the same study.

  • Cognition

    Cognitive tasks with automated scoring, some of which use verbal responses captured on the same platform.

  • Gait and Balance

    Instrumented gait and balance measures that are often collected alongside speech tasks in the same study.

  • Patient-Reported Outcomes

    The participant's own report of symptoms and function, adding their perspective to speech measures.

Bring voice biomarkers to your trial

Discuss speech tasks, languages, planned features, review requirements, supporting evidence, and data delivery for your clinical trial with BioSensics.

Discuss your study