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ERT, a global provider of high-quality patient safety and efficacy data collection solutions for use in clinical drug development, today announced the availability of a centralized Ambulatory Blood Pressure Monitoring (ABPM) solution. ABPM enables biopharmaceutical companies to efficiently evaluate the efficacy and cardiac safety of both hypertensive and anti-hypertensive drugs as well as endpoints for cardiovascular and cerebrovascular outcomes.
The ABPM solution is an extension of ERT’s suite of centralized cardiac safety solutions and services, which improve data quality, reduce investigator workload, and improve the overall user experience at the investigative site. The solution utilizes the Mortara Ambulo™ 2400 monitor, which is validated to stringent clinical accuracy standards, including the British Hypertension Society, AAMI SP-10, and the global ISO 81060-2:2009 standard. Based on patented, oscillometric technology and built-in actigraphy for automatic categorization of sleep/awake cycles, ERT’s ABPM solution captures accurate 24-hour readings of systolic and diastolic blood pressure, mean arterial pressure, and pulse rate.
“Mortara is excited to expand its relationship with ERT to include our Ambulo technology in their ABPM solution. In analyzing past practices for centralized ABPM, we identified significant opportunities for innovation to create a solution that was better tuned to the needs of clinical trials. Mortara’s ABPM platform is that solution and we are confident that biopharmaceutical companies will find it to be a practical and reliable tool to meet their clinical development needs,” commented Dr. Justin Mortara, CEO, Mortara Instrument.
ERT’s ABPM solution includes a seamless, digital data transfer process that eliminates the collection of erroneous site, patient, and visit information. It enables clinical trial sponsors to benefit from increased reporting efficiencies and to further reduce site burden by integrating ABPM with ECG and Holter services. Trial sponsors will also benefit from an efficient project assurance process; integrated device logistics and supply management; integrated demography and visit checks; and integrated data management and delivery, including access to reports on My Study Portal, ERT's integrated study portal.
“ERT's aim is to improve the science of cardiac safety while helping sponsors increase efficiencies and reduce overall costs through the adoption of a fully-centralized approach,” said Amy Furlong, Executive Vice President and Chief Operations Officer, ERT. “We are pleased to add the ABPM solution to our comprehensive suite of centralized clinical endpoint solutions and to continue providing innovative solutions for our customers.”
As part of its ongoing educational initiative, ERT is hosting a complimentary Webinar on Wednesday, June 12 entitled, "The Role of Ambulatory Blood Pressure Monitoring in Clinical Drug Development”. For additional information and to register, visit http://www.ert.com/resources/webinars/.