Products

BioDigit Clinic™

Motor, speech, and cognitive assessments, video, eCOA, and vital signs in one integrated solution.

BioDigit Clinic brings study-specific assessments into one on-site workflow. It supports consistent data collection, simplifies work for site teams, and reduces the need for participants to use separate assessment systems.

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$3M NIH award supports integration with the PSP Trial Platform

Supported by a $3 million NIH award, BioSensics is integrating its digital health technologies, including BioDigit Clinic, with the Progressive Supranuclear Palsy Trial Platform (PTP). The platform is designed to evaluate multiple candidate therapies under a shared protocol, with approximately 50 sites planned across North America.

Learn about the PTP (opens in a new tab)

One integrated solution for on-site data collection

Separate assessment systems can add work for site teams and participants and complicate data management. BioDigit Clinic brings multiple assessments into one integrated solution, combining eCOA, speech, cognition, video, motor function, and vital signs in a study-specific workflow that supports consistent collection and review.

What BioDigit Clinic collects

Configure on-site data collection across six categories to match the study protocol and visit schedule.

  • eCOA

    Electronic clinical outcome assessments with automatic scoring at collection, where supported by the instrument.

  • Speech measurements

    Speech assessments with built-in quality checks and automatic analysis of vocal features.

  • Cognitive measurements

    Digital cognitive assessments with standardized administration procedures across sites.

  • Video capture

    Video capture with quality checks and automated analysis for supported movement and functional assessments.

  • Motor measurements

    Digital motor assessments using finger tapping and spiral drawing tests.

  • Vital signs

    Vital sign measurements from integrated FDA-listed devices selected for the study.

Simplify on-site assessment workflows

Bring selected assessments together to support data quality, simplify site workflows, and make study visits easier to manage.

  • Data integrity

    Standardized capture and automated scoring support consistent records and help reduce transcription errors.

  • Streamlined workflows

    A shared assessment workflow simplifies setup and day-to-day data collection for site staff.

  • Less assessment burden

    Collecting selected assessments in one system reduces switching between devices and applications.

  • Real-time scoring

    Automatic scoring and built-in quality checks help flag issues during supported assessments.

  • Efficient study operations

    Integrated data collection can reduce duplicate work and simplify study operations.

  • Timely data review

    Coordinated collection and scoring help study teams review data and address issues promptly.

BioDigit Clinic specifications

BioDigit Clinic specifications
Specification Details
Solution Integrated on-site digital data collection for clinical trials, tailored to each study
Data types eCOA, speech, cognition, video, motor function, and vital signs
eCOA Electronic clinical outcome assessments; automatic scoring for supported instruments
Speech Speech measurements with quality checks and automated vocal feature analysis
Cognitive Standardized digital cognitive assessments
Video Video capture with quality checks; automated analysis for supported assessments
Motor Digital motor assessments via finger tapping and spiral drawing tests
Vital signs Integrated FDA-listed devices selected for study-specific vital sign collection
Scoring Automatic scoring and quality checks for supported assessments
Data storage Secure collection and storage under study-specific data management and access arrangements
Quality and compliance ISO 13485 quality management; controls to support applicable 21 CFR Part 11, ICH GCP, HIPAA, and GDPR requirements

Quality, security, and compliance support

BioDigit Clinic supports regulated clinical research through quality processes and data protection controls. Compliance depends on the study configuration, intended use, and operational procedures.

  • ISO 13485 quality

    Developed and maintained under an ISO 13485 certified quality management system.

  • 21 CFR Part 11

    Supports 21 CFR Part 11 requirements for electronic records and electronic signatures.

  • ICH GCP

    Supports workflows aligned with applicable FDA guidance and ICH Good Clinical Practice principles.

  • HIPAA

    Safeguards support the handling of protected health information under applicable HIPAA requirements.

  • GDPR

    Data protection controls support applicable GDPR obligations for study-related personal data.

  • Secure by design

    Security controls support protected collection and storage of study data.

Part of the BioSensics ecosystem

BioDigit Clinic supports on-site assessments within BioSensics' platform. Combine it with BioDigit Home and wearable sensors to bring clinic and remote data together for study teams.

  • At-home monitoring

    BioDigit Home

    Remote data collection that complements clinic visits with assessments configured for use at home.

  • Cognitive assessments

    BioDigit Cognition

    Standardized cognitive assessments with automated scoring, administered in the clinic or at home on the same platforms.

  • Speech assessment

    BioDigit Speech

    Automated speech analysis with more than 40 vocal features across supported assessments.

  • Research data

    BioDigit Database

    Research datasets that support digital biomarker development, with access subject to data-use agreements.

Bring integrated assessments to your study sites

Contact our team to discuss assessments, integration, and support for your study.

Request a demo