ERT Develops Industry’s First Integration of Continuous Glucose Monitoring Data & eCOA
ERT, a leading provider of high-quality patient data collection solutions for use in clinical drug development, recently announced a data license agreement with Dexcom to integrate glucose information captured via continuous glucose monitoring (CGM) and traditional self-monitoring of blood glucose (SMBG) with symptomatic/quality of life data collected via its electronic Clinical Outcome Assessment (eCOA) system.
The wireless, integrated solution is actively used to collect endpoint data in worldwide clinical trials, generating larger data sets to analyze glycemic control with new therapies.
ERT designed and built a novel solution that integrates continuous glucose data to meet the increasing needs of clinical researchers. By integrating data collected on ERT’s eCOA system with CGM data collected on Dexcom G4 CGM devices, clinical researchers gain expansive data sets to quantify what patients are experiencing as they manage their diabetes and diabetes-related symptoms. And, by leveraging ERT’s trial oversight solution, Insights Cloud, clinical researchers gain access to holistic views and proactive monitoring of data quality and compliance, resulting in greater visibility into trial progress.
Glucometers have been integrated with ERT’s eCOA system for several years, but now researchers can integrate retrospective CGM data with eCOA to collect even more endpoint data in their diabetes trials. The use of CGM as an adjunctive approach to traditional SMBG is poised for dramatic expansion within clinical research.
“Using CGM in clinical trials offers numerous advantages to clinical trial sponsors who truly seek to understand the full impact of diabetes on patients’ quality of life,” said Ron Sullivan, Executive Vice President, eCOA at ERT. “We are pleased to deliver the industry’s first integrated eCOA/CGM solution and look forward to continuing our relationship with Dexcom as we explore other opportunities to enhance treatment satisfaction for the millions of patients worldwide who are living with and managing diabetes.”
ERT is a leading provider of high-quality patient data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services, and clinical consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process. ERT delivers widely deployed solutions in centralized Cardiac Safety, Respiratory, and electronic Clinical Outcome Assessments (eCOA) – which includes patient-, clinician-, observer- and performance-reported outcomes – and cloud-based analytics and performance metrics. By efficiently integrating these solutions through a system built upon a scientific and regulatory foundation, ERT collects, analyzes and delivers safety and efficacy data critical to the approval, labeling and reimbursement of pharmaceutical products. For more information, visit www.ert.com.
Total Page Views: 1084
