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<p>We deliver the expertise and purpose-built cloud platform to design, deploy, and analyze digital endpoints from wearable sensors.</p>


Transforming Clinical Trials and Changing Patients’ Lives with Novel Digital Endpoints

About Us

Deliver Value for All Stakeholders

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Drive Success at Every Phase

Are You Asking These Vital Questions?

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<h4>How will your evidence package drive internal decisions on future trials?</h4>
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<p>Pre-clinical and Phase 1 investigations are opportunities to gather valuable data that set subsequent trials up for success.</p>
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<p>Identifying meaningful aspects of health (MAH) to patients will help determine patients’ perspectives and preferences for capturing these digital data via wearable technology.</p>


<h4>Are you considering the patient&#8217;s perspective?</h4>
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<p>Health authorities such as the FDA prioritize patient-focused drug development, ensuring that selected endpoints capture aspects of health that are most meaningful to specific clinical populations.</p>
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<p>Our experts will help you minimize burden, maximize engagement and retention, and continually consider the patient perspective to generate real and lasting value.</p>


<h4>Are you designing the right wearable sensor and digital endpoint strategy?</h4>
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<p>High-quality datasets are dependent on both the validity of the technology, the analytics to produce the selected endpoints, and the willingness of the population to adhere to the data collection protocol.</p>
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<p>We are proven experts in evaluating the validity and usability of digital health technologies, and our scientists will guide you through selecting and procuring the best fit-for-purpose wearable sensor solution for your clinical program, setting you up for success.</p>


<h3>Strategic planning in Phase 1 for use throughout the approval process.</h3>


Pre-Clinical & Phase 1

<h4>Do your study design, data collection procedures, and analysis plan support your research question?</h4>
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<p>What you choose to measure and how you collect the data determine the conclusions you are able to make.</p>
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<p>Our proprietary cloud platform streamlines data collection across multiple technologies and implements rigorous data cleaning and artifact detection procedures necessary for the precise interpretation of high-resolution sensor signals.</p>


<h4>Are you demonstrating early efficacy?</h4>
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<p>Novel digital endpoints that capture continuous, ecologically valid outcomes as patients go about their daily lives provide vital early signs of efficacy.</p>
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<p>Our dedicated data scientists will guide you in sophisticated longitudinal data analysis to generate critical insights that support timely and efficient decision-making.</p>


<h4>Are you building the evidence to support subsequent phase 3 endpoints?</h4>
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<p>For over a decade, we have been developing real-world digital clinical measures from digital health technologies.</p>
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<p>Our scientists will help you define and execute an evidence-generation algorithm that leverages your phase 2 data to support the clinical validity of novel endpoints in subsequent phase 3 studies.</p>


<h3>Endpoints to improve efficacy signal.</h3>
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Phase 2

<h4>Will your digital endpoint-derived evidence package detect meaningful change?</h4>
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<p>A clean and compelling package of meaningful data is essential to gaining regulatory approval.</p>
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<p>To be useful in drug development, digital endpoints must be sensitive to change. Based on years of experience, our scientists will guide you in selecting and defining the endpoint parameters most likely to respond to treatment.</p>


<h4>How will you handle missing data?</h4>
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<p>Data collected outside of clinic settings can be subject to vital gaps due to patient non-compliance and technology malfunction.</p>
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<p>Our proprietary cloud platform allows for near-real-time compliance monitoring, seamlessly ensuring high-quality data are being collected and cleaned per the protocol and resulting in datasets with very low rates of missingness.</p>


<h4>Do your digital health technology datasets conform to CDISC standards?</h4>
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<p>Datasets submitted to health authorities such as the FDA must conform to pre-specified standards.</p>
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<p>Our data management experts will work with your team to ensure the digital data packages are delivered in a format that supports your statistical analysis plan, conforms to regulatory standards, and is auditable back to the source within our fully compliant platform.</p>


<h4>Are your data regulatory-ready?</h4>
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<p>In order for health authorities to make regulatory decisions based on digital endpoints, sufficient evidence must exist to support their analytical and clinical validity.</p>
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<p>Our scientists will guide your team in planning and executing the necessary investigations by producing regulatory-ready reports and by optimizing communication pathways with key regulators.</p>


<h3>Precision digital endpoints for successful regulatory submission.</h3>


Phase 3

<h4>Does your evidence strategy support label differentiation?</h4>
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<p>Developing a digital evidence strategy that gives you the sharpest insight into outcomes of interest, enables you to more effectively detect and deliver market value and label differentiation.</p>


<h4>Will your evidence strategy differentiate your product in the market?</h4>
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<p>Care in choosing your evidence strategy can bring lasting value in the marketplace. Selecting measures that provide real-world insight into the effects and impacts of your product sets you up to make compelling arguments for unique value propositions in the market.</p>


<h4>Can your data support future trials?</h4>
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<p>Our proprietary cloud platform streamlines collection, cleaning, analysis, and reporting.</p>
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<p>Easily accessible, validated data free from artifact overcomes barriers to possible use in future studies, adding value to your investment.</p>


<h3>Discover and deliver enduring real-world patient impact and market value.</h3>


Phase 4

Our Value

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