ActiGraph Clinical Trial Solutions
Built on more than 20 years of real-world data capture expertise, our fit-for-purpose ecosystem of wearable biosensors and software tools deliver digital data in near real time through a flexible cloud-based technology platform designed around the challenges and complexities of the clinical development process.
FDA-Cleared, Medical-Grade Wearables
ActiGraph’s medical-grade wearable technology has been deployed in more than 100 pharmaceutical drug trials to capture real-world biometric data relating to physical activity, mobility, sedentary behavior, and sleep. ActiGraph is ISO-13485:2016 certified, and our activity monitors are FDA 510(k) cleared Class II medical devices in the U.S. and adhere to regulatory standards worldwide.
Real-Time, Real-World Digital Data
Participant biometric and study compliance data are continuously transmitted to the CentrePoint system, where they can be accessed by investigators and study personnel in near real-time. The ability to monitor behaviors remotely reduces the burden to participants and provides sponsors with faster and better insights, improved decision-making abilities, and greater trial oversight.
Innovative, Flexible Technology Ecosystem
ActiGraph’s CentrePoint platform leverages cloud, wireless, and mobile technologies to provide flexible data capture and transfer configurations to support various study designs and methodologies, including decentralized trials. Our ecosystem supports integrations with other connected health sensors, ePRO tools, custom mobile applications, and third party EDC platforms.
Transparent Algorithms, Future-Proof Data
ActiGraph uses public algorithms developed by the scientific community – not proprietary “black box” equations – to convert raw data into a variety of validated, population-specific measures. High resolution, raw e-source data is available for advanced analytics, including digital biomarker and clinical endpoint development. ActiGraph raw data is future-proof, meaning it can be reprocessed indefinitely as new algorithms and analytic methods are developed.
End-to-End Clinical Trial Support
Our seasoned team of GCP-certified project managers and subject matter experts (SMEs) understand the challenges of implementing new technologies into the complex and rigorous clinical research environment. From protocol development to post hoc data analysis, ActiGraph offers a full range of services to ensure efficient site processes, smooth technology deployments, and the collection of relevant and clinically meaningful participant data.
Subject Matter Expert Consulting
Our in-house subject matter experts (SMEs) have extensive experience in the collection and interpretation of actigraphy data across a wide variety of therapeutic areas and disease populations. ActiGraph SMEs can assist with protocol development, endpoint selection and validation, algorithm refinement, and regulatory data submission.
Study Site Training
We provide a customized, protocol-specific Site Manual and Patient Guide for each study, and our highly knowledgeable project management team will guide your site personnel through comprehensive remote or on-site CentrePoint training sessions.
Site Shipping Logistics
Our integrated logistics platform eliminates the burden of technology disbursement and inventory management. ActiGraph will ship patient packages directly to each study site, monitor study inventory, and manage all hardware repairs and replacements.
In-Trial Data Screening
ActiGraph's expert Data Management team can help to ensure the integrity of your study data with in-trial data screening. Tiered services include wear compliance verification, site error checks and queries, and monitoring for changes in activity or sleep levels.
Data Configuration and Transfers
Our Data Management team can configure your study data to match the specifications of the sponsor or CRO Data Management Team. This includes filtering the data to provide protocol-specific endpoints to the EDC system.
Choose a Technology Partner with Unmatched Expertise
With more than 20 years of large-scale, multi-site study expertise, ActiGraph is your trusted advisor and leading provider of medical-grade physical activity and sleep monitoring solutions. Please contact us to learn more or discuss your specific clinical research needs.
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