Signant Health, formerly CRF Health and Bracket, is proud to announce that it has integrated its industry leading eCOA platform TrialMax®, with ActiGraph’s Centre Pointsystem. The integration, which includes ActiGraph’s FDA 510(k) cleared sensors, helps simplify the process of collecting and monitoring real-world activity, mobility, and sleep outcomes data for patients and researchers.
The Trial Max and Centre Point system integration is yet another step pointing towards the growing importance of measuring real-world patient functioning in clinical trials.Home-based activity and sleep monitoring, measured using ActiGraph’s research-grade wearable devices, provides important insights into real-world functioning that are applicable to drug development in a broad range of disease indications. Many diseases adversely affect activity and sleep, which ultimately impacts quality of life. Measuring treatment-related improvements in free-living activity and sleep provides valuable and objective insight into the aspect of treatment, and is essential in the study of sleep disorders, and also a critical component used to assess patient quality of life in many other conditions including pain, asthma, COPD, overactive bladder, cancer, and others.
Using multiple technologies in clinical trials can complicate participation for sites and patients. Signant Health has developed an integration with ActiGraph’s FDA 510(k) cleared sensors to make practical implementation easier for sites and patients and provide greater value from the combination of wearable and eCOA data collected and aggregated using the TrialMax® platform.
The integration provides important efficiencies and simplifies workflow for study sites. Patients are enrolled using Signant Health’s TrialMax eCOA platform, and real-time integration with ActiGraph’s CentrePointplatform means that all enrolment activities are accomplished through the single TrialMax interface. Sites and Sponsors can also view activity and sleep parameters alongside patient-reported outcomes data collected via TrialMax through Signant Health’s online reporting solution. In addition, data-driven notifications and alerts can be triggered based on both the activity/sleep and eCOA data collected using TrialMax – for example, providing reminders to patients to encourage compliance if they have worn the ActiGraph device for less than the requested number of hours per day.
With this integration, Signant Health continues to expand and support its promise to offer the industry more patient-centric trial designs. Bill Byrom, Signant Health’s VP Product Strategy & Innovation, said“It’s important that patients continue to experience trials that benefit them without burdening them. Using ActiGraph’s devices not only provides a simple and efficient experience for patients, it also simplifies and streamlines trials for sites and sponsors while offering better data and insights.”
Byrom added “It’s also beneficial for compliance. The combination of ActiGraph’s activity and sleep monitoring with TrialMax eCOA enables proactive data-driven alerts and notifications to sites and patients. We believe this has the potential to reduce unusable data and improve data quality when measuring real-world activity and sleep alongside patient-reported outcomes in clinical trials”.
Who Is Signant Health?
The best technology succeeds in the background. Signant Health provides solutions that simplify every step of the study participant journey to make it easier for people to participate in, and for sites and study teams to run, clinical trials. Signant unites eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industry’s most comprehensive patient-centric suite – an evolution built on more than 20 years of proven clinical research technology. Our intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable hundreds of sponsors and CROs (including all Top 20 pharma) to extend the reach of drug development, expand patient opportunities and improve data quality – helping them bring life-changing therapies to our families and communities around the world. Take a significant step toward patient-centricity at signanthealth.com. CRF Health and Bracket are now Signant Health.
ActiGraph is a leading provider of medical-grade physical activity and sleep monitoring solutions for the global scientific community. ActiGraph’s FDA-cleared wearable actigraphy monitors and robust analytics platform have been widely used to quantify human movement in academic and population health research for nearly two decades. In recent years, the company’s monitoring solutions have been steadily adopted by pharmaceutical and life sciences organizations seeking to capture real-world objective outcomes related to physical activity, mobility, and sleep behaviour for patients enrolled in clinical trials. For more information, visit www.actigraphcorp.com