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ERT Integrates Remote Biosensor Patch with Electronic Clinical Outcome Assessment System
  • USA - English


News provided by

ERT

Jun 09, 2015, 10:20 ET

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“.. We hope to show clinical researchers the ease and value of integrating important objective and subjective data to gain more comprehensive patient insight during clinical development." said Ron Sullivan, EVP, eCOA at ERT

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PHILADELPHIA– June 9, 2015 (PRWEB) June 09, 2015 -- ERT, a leading global provider of high-quality patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions, today announced the integration of an innovative wearable biosensor which captures and wirelessly transmits real-time, continuous, clinical-grade biometric measurements into the ERT electronic Clinical Outcome Assessment (eCOA) system. ERT will showcase a proof of concept demonstration of the integration at its Innovation Lab in Booth #2000 at the Drug Information Association (DIA) Annual Meeting, June 14-17 in Washington, DC.

The ERT Innovation Lab capitalizes on the acceleration and diversification of technological advances for use in new medical product development and broad clinical care. DIA Annual Meeting attendees can visit the Innovation Lab to see demonstrations of progressive product advancements – including the biosensor patch / eCOA system integration – which are being developed to help pharmaceutical companies and CROs meet clinical trial objectives more efficiently and reliably.

“We are excited to have integrated a clinical grade wearable biosensor with our eCOA system to expand the extremely exciting possibilities of collecting electronic patient data for clinical trials,” said Ron Sullivan, Executive Vice President, eCOA at ERT. “By demonstrating this integration at our Innovation Lab at the DIA Annual Meeting, we hope to show clinical researchers the ease and value of integrating important objective and subjective data to gain more comprehensive patient insight during clinical development.”

The biosensor is a disposable, wireless patch worn on the chest. Its thin, light form factor is comfortable and discreet while providing healthcare professionals access to unprecedented amounts of continuous vital sign data on their patients. The patch contains cutting-edge sensors and electronics, along with advanced algorithm technologies, to provide continuous, clinical-grade measurements of ECG, respiratory rate, heart rate, heart rate variability, skin temperature, physical activity, posture and fall detection.

As a proof of concept, ERT is capturing patient fall detection data from the patch biosensor and using it to trigger an episodic electronic diary assessment to capture information about the circumstance of the fall. Sponsors can use one or more of the vital statistics as needed to support efficacy and/or safety endpoints that meet their clinical development objectives.

Learn more about ERT, the wireless biosensor / eCOA system integration and other DIA Annual Meeting Innovation Lab demonstrations at http://www.ert.com/dia-annual-meeting/.

About ERT
ERT (http://www.ert.com) is a leading provider of high-quality patient safety and efficacy endpoint 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 throughout the product lifecycle. ERT delivers the most widely deployed solutions in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, 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. ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Switzerland, Japan and Germany.

Christine Tobin, ERT, http://www.ert.com/, +1 (412) 719-4568, [email protected]

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