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Transform Your Trials

Our Core Objective 
Take on the operational and analytical complexity of wearable digital health technologies.

We Are Your Wearable Sensor CRO

VivoSense Solutions

Unlock the Power of Digital

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Managed via the VivoSense End-to-End Platform

1 - Study Startup

DHT Data Investigation, Statistical Analysis, and Clinical Validation

3 - Study Closeout

DHT Operationalization, Monitoring, Data Collection, and Data Transfer

2 - Study Conduct

Study Startup

DHT Strategy and Protocol Development: We carefully craft your digital strategy to enable rapid decision-making, satisfy regulations, and achieve success.

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We guide you in selecting a sensor that balances patient burden, sensor functionality, and cost.
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Selecting the correct sensor is critical to your success. VivoSense has worked with over 70 clinical and consumer-grade sensors for over a decade and our clinical trial experts understand the complexities of choosing the correct fit-for-purpose solution.

Select Sensors

We select measures that matter to patients, are accurately quantifiable, and are clinically relevant.
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Sufficient evidence and scientific rationale must exist to support your measure’s context of use. Whether you’re using DHTs to derive a screening, monitoring, prediction, or safety biomarker, an exploratory endpoint, or an efficacy endpoint, our team of scientists will select measure(s) with the appropriate amount of supporting evidence needed to achieve your research goals and set you up for success throughout your clinical development program.

Select Measures

We work with your team to develop a DHT methodology that integrates with other study procedures as seamlessly as possible, minimizing the burden on patients, sites and study personnel, and maximizing DHT data fidelity and interpretability.
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Optimizing DHT procedures impacts not only the generation of actionable datasets with minimal missing data but has unquestionable effects on participant enrollment, retention, adherence, and overall trial experience. VivoSense science and operations teams have tried and tested an extensive array of DHT data collection and monitoring procedures across therapeutic areas, allowing us to meticulously develop the DHT blueprint for your trial, including proactively identifying risks and planning their mitigation strategies.

Develop Procedures

Study Conduct

DHT Operationalization, Monitoring, Data Collection, and Data Transfer: Utilizing the VivoSense Platform, our team will capture, clean, and analyze DHT data, to deliver the highest quality results to all stakeholders.

We manage and oversee all components of DHT operationalization, including procurement, vendor management, distribution to sites, data integrations, training of study personnel, and continuous oversight of DHT-related activities.
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Proper operationalization and oversight throughout the duration of your trial is critical to the production of interpretable and actionable DHT datasets. The proprietary VivoSense platform is where the VivoSense team performs all DHT-related activities throughout your trial. The platform serves as a centralized location where your study team has full visibility into the actions being carried out by the VivoSense team, providing a real-time system for your team to observe progress on DHT-related tasks and timelines, access resources, communicate with the VivoSense operations team, and generate reports.

Operationalize DHTs

We ingest high-resolution and aggregated DHT data directly into the VivoSense platform. When data is collected from disparate sources, such as multiple wearable sensors (e.g., actigraphy and CGM), ePRO, and clinical data, we synchronize and organize the data using proprietary methods to create contextual rich DHT datasets that are ready for analysis. The platform automatically audits all data transformations, and data are always revertible back to the source if needed.
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The fully compliant, automated, and auditable data ingestion and synchronization of DHT data ensure data are regulatory ready and allow for complex measure development and analysis, removing the burden from participants, sites, and study personnel to retrospectively transfer and synchronize relevant data.

Collect Data

We continuously monitor data quality and compliance. We use a combination of proprietary algorithms and human review to evaluate incoming data in near-real-time, allowing us to rapidly detect questionable or missing data, investigate its source, and sensibly deploy mitigation activities if warranted per the protocol.
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DHT data collected in real-world environments can be prone to error from a variety of sources, including signal artifact, participant non-compliance, site non-compliance, protocol deviations, and technology malfunction. When incoming DHT data are not reviewed in near-real-time, it is common to observe &gt;40% or more missing data, compared to &lt;5% missingness when VivoSense’s monitoring and cleaning methodologies are implemented.

Monitor and Clean Data

We craft and deliver custom data exports of digital measures based on your study needs, including datasets that adhere to Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) standards for clinical trial data. We review and reconcile derived data with study protocols prior to delivering datasets to your study team.
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Custom data specifications are agreed upon with your data management team prior to data analysis and delivery, and allow your biostats team to focus on carrying out analyses specified in the statistical analysis plan, rather than transforming and making sense of complicated data structures.

Deliver Custom Data Exports

Study Closeout

DHT Data Investigation, Statistical Analyses, and Clinical Validation: Our expert scientific team will work with you to analyze your digital data, establish clinical validity, and prepare regulatory ready reports.

We perform a systematic investigation into the attributes and properties of the data to accurately inform subsequent analysis within the population specific to your study.  We further quantify and investigate any sources of poor data quality or missingness and implement appropriate remediation.
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DHTs are new tools that are being used to conduct innovative research; consequently, there is often insufficient publicly available evidence to set precedence or best practice methodology within the population specific to your study. Feasibility investigations within the specific context of use reduce risks and save resources by setting the stage for systematic, efficient, and well-informed data analyses and interpretation.

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Assess Feasibility

We comprehensively evaluate DHT outcome data, including statistically evaluating treatment response within persons, between groups, and between responders versus non-responders.
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When evaluating change in DHT-derived endpoints, careful consideration must be given to identifying appropriate stratification factors, covariates and/or normalization/transformation procedures. In the case of primary or secondary endpoints, these procedures must be clearly defined in the statistical analysis plan and be based on evidence from previous investigations.

Evaluate Treatment Response

We will evaluate the extent to which novel, DHT-derived endpoints are associated with established endpoints and determine the minimal clinically important difference (MCID) using established methods.
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Depending on the positioning of the endpoint and the maturity of the measure, establishing the clinical validity of the DHT-derived outcome will be essential to regulatory acceptance.

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Establish Clinical Validity

We create insightful and compelling data visualizations to help interpret and communicate results to all stakeholders, including for inclusion in regulatory briefing documents.
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Well-designed tables and figures are imperative for clearly and concisely presenting complex DHT data to stakeholders.

Visualize, Interpret and Report

Our Solutions

Vivosense

Get in touch to learn more about what we can do for your trials.

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