Garmin® Health and ActiGraph™ Collaborate on Wearable Solutions for Clinical Trials
ActiGraph Clinical Trial Solutions
Wearable technologies provide valuable insight into real-world patient behaviors, helping investigators and sponsors evaluate treatment responses and make faster, better informed clinical decisions. Built on nearly 20 years of real-world data capture expertise, ActiGraph solutions deliver high quality, meaningful activity and sleep-related outcomes through a flexible cloud platform designed around the challenges and complexities of the clinical development process.
Medical-Grade Wearable Solutions
ActiGraph’s medical-grade wearable activity monitoring system has been deployed in dozens of pharmaceutical drug trials around the world to capture high quality physical activity and sleep data. Our activity monitors are FDA 510(k) cleared Class II medical devices in the U.S. and adhere to regulatory standards worldwide.
High Quality Patient Data
We’ve worked in collaboration with the global academic research community for nearly two decades to deliver the highest quality data possible to our clients. We use publicly available algorithms developed and validated by members of the scientific community to provide our users with a robust collection of physical activity and sleep measures, including:
- Daily activity profile - steps taken, kcals, and activity counts
- Bouts of sustained physical activity
- Intensity of physical activity (sedentary, MVPA, etc.)
- Sleep score, including sleep time and efficiency
- Patient wear time compliance
Innovative, Flexible Technology Ecosystem
ActiGraph’s CentrePoint platform leverages the power of cloud, wireless, and mobile technologies to simplify and enhance the patient experience, while also providing sponsors and investigators with near real-time data during the trial. Our ecosystem of hardware and software tools offer the flexibility to integrate with other types of connected health sensors, custom mobile applications, and third party EDC platforms.
Clinical Trial Support Services
We’ve partnered with major pharmaceutical companies and contract research organizations (CROs) in dozens of clinical trials across various phases, therapeutic areas, and patient populations. Because we understand the challenges of implementing new technologies within the complex drug development environment, we offer a variety of support services to make sure activity monitor deployment runs smoothly and captured data is accurate and clinically meaningful.
Subject Matter Expert Consulting
We’ve developed a network of subject matter experts (SME) that can assist with protocol development, device deployment, endpoint validation, algorithm development, and physical activity and sleep analysis during the trial or after Database Lock. Our SME partners have extensive experience with ActiGraph products and the interpretation of activity and sleep metrics.
Data Configuration & 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.
In-Trial Data Screening
Help guarantee the integrity of your study data with in-trial data screening. Tiered services include wear compliance verification, site error checks and queries, and monitoring changes in activity or sleep levels.
Site Shipping Logistics
Eliminate the hassle and inefficiencies of activity monitor disbursement and management. We’ll ship activity monitors to each site, monitor study inventory, and handle device repair and replacements.
Site Training
Let our Accounts Management team train your site personnel with protocol-specific CentrePoint training sessions, performed either on-site or via telecomm.
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Choose a Technology Partner with Unmatched Expertise
With 15 years of large-scale, multi-site study expertise, ActiGraph is your premier provider of medical-grade physical activity and sleep monitoring solutions. Please contact our Sales team to learn more or discuss your specific patient monitoring needs.
Contact our Sales team