Usability Evaluation Program
Our program allows study teams to make data-driven decisions about integrating DHTs by conducting usability validation prior to your trial.
Usability Evaluation Program
Study teams can now conduct usability validation using our comprehensive DHT solution through the Usability Evaluation Program prior to your trial.
Our Services
Scientific Services
End-to-End Scientific Support to Accelerate Clinical Development
Usability Validation
Usability is essential to realizing the full potential that digital health technologies (DHTs) can bring to clinical research. Recognizing this, the Digital Medicine Society (DiME) recently announced DataCC V3+ framework, which adds usability validation to the V3 components of verification, analytical validation, and clinical validation.
Usability validation involves establishing best practices for the design, development, and usability testing of sensor-based DHTs. Device characteristics such as design, battery life, and memory storage affect usability. The scalability, ease of use, and integrations of the platform are equally important. Each element is critical to generate the high-quality, complete data essential to a successful study.
Poor usability can lead to site disengagement, low patient adherence, and incomplete or low-quality data. In clinical research where multiple stakeholders (including study teams, sites, and participants) are crucial to trial success, validating usability helps you maximize the value of your DHT investment and capture the value that DHTs can bring to your development program.
Usability Evaluation Program
To validate that ActiGraph’s end-to-end DHT solution is fit-for-purpose for your specific study, we offer an evaluation program for clinical trial sponsors who have a qualified upcoming trial. This allows study teams to perform usability validation with our complete DHT solution before your trial.
The Evaluation Program includes:
- 5 wearable devices
- 5 CentrePoint Data Hubs and cellular data
- 2 months access to CentrePoint digital health platform
- 2 months Project Management and user support
- Science consulting engagement
- 1 virtual training session
- API or 1 standard data transfer at end of evaluation
View the Case Study of the usability evaluation that UCB conducted with ActiGraph to select fit-for-purpose DHTs for their clinical trials.
Delivering Exceptional Scientific Services for Your Clinical Trials
How Our Team Can Help Accelerate Your Clinical Development Program
At ActiGraph, we understand that introducing novel or additional elements to your development program can bring great opportunities, but also can come with risks. That’s why we built a world-class Science Team so you can leverage our expertise and experience to realize benefits such as improved enrollment, reduced participant burden, accelerated development timelines, and supported regulatory engagement.
We help you incorporate DHTs with a detailed deployment consultation and help you plan for effective fit-for-purpose data collection by leveraging shared best practices and avoiding common pain points.
Endpoint Design
Select and design the DHTs for the context of use and support the content validation of meaningful aspect of health.
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- Technical literature review and documentation
- DHT feasibility and usability evaluation
- Patient-focused research
- Protocol development
Algorithm Validation
Develop, validate, and implement algorithms that are fit-for-purpose for the context of use.
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- Compare and evaluate algorithm performance, including equivalency studies comparing devices
- Develop and implement new algorithms relevant for your study population(s)
- Refine and validate algorithms and data output
DHT Data Analysis
Conduct appropriate biostatistical analysis of the digital endpoints with consultation and/or full services.
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- Develop digital endpoint statistical analysis plan
- Including raw data from other wearable devices, such as Philips' discontinued Actiwatch
- Program and execute statistical analysis plan of wearable raw data
- Manuscript development and publication
Regulatory Engagement
Support regulatory engagement with our experience, knowledge, and documentations.
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- Consultations for regulatory engagement
- Clinical validity evaluation
- Develop Fit-For-Purpose regulatory dossier
ActiGraph Science Team
Sensor-based DHTs are inherently more complex than traditional clinical measures. To help study teams maximize the benefit of DHTs, ActiGraph has built a world-class team of engineers, data scientists, biostatisticians, and clinical scientists. Our multidisciplinary team provides end-to-end services to tailor the application of DHTs to the clinical hypotheses and reveal the otherwise invisible clinical insights derived from high-quality sensor data.
Christine Guo, PhD
Chief Scientific Officer
Rakesh Pilkar, PhD
Senior Data Scientist
Ali Neishabouri, PhD
Head of Data Science
Dawid Gerstel, PhD
Data Engineer
Matthew Patterson, PhD
Senior Data Scientist
Sylvain Zorman, PhD
Director Digital Health Sciences
Additional Resources
Sensor-based DHTs enable previously inaccessible insights into participant behavior to advance clinical development programs, but integrating wearables into a clinical trial calls for strategic alignment, meticulous planning, and early engagement with DHT partners. We've selected some useful resources below that share examples and best practices for maximizing the value of your DHT investment.
Optimizing DHT Operational Excellence
Schedule a Meeting with Our Science Team
Schedule a meeting with a member of our Science Team to learn more and receive personalized guidance on maximizing the benefits of digital health technologies (DHTs) throughout the clinical development lifecycle.
Contact Our Sales Team
Do you have an upcoming trial that could benefit from the use of digital measures? If so, contact us to learn more about our usability evaluation program.
