Washington, DC — Cardiocore, a premier cardiac core lab, and Tiba Medical, a leading blood pressure monitoring technology provider, announced today their alliance delivering advanced blood pressure monitoring solutions for both cardiac safety and efficacy clinical trials. The partnership is highlighted this week in Cardiocore’s exhibit (booth #511) at the Drug Information Association’s 46th Annual Meeting, here in Washington, DC.
As part of the agreement, Cardiocore offers Tiba Medical’s Blood Pressure Electronic Data Capture (BP-EDC) solutions to sponsors and Clinical Research Organization (CRO) partners. These solutions comprise a best-of-breed family of ambulatory, office and home blood pressure monitoring devices – including Tiba Medical’s flagship Ambulo 2400 Ambulatory Blood Pressure Monitoring (ABPM) systems.
The solution supports investigative sites with rapid Internet data transmission and a secure web portal for data management and reporting. Validated and verified to stringent industry standards including the FDA’s 21 CFR Part 11 and Good Clinical Practices guidelines, the system is specifically designed to enable seamless acquisition, analysis and reporting of blood pressure data in global clinical trials.
Special features include real-time data verification that ensures each recording’s completeness prior to transmission, and advanced configuration settings that accommodate even the most complex recording schedules. The Ambulo 2400 also contains a unique actigraphy system. This technology continuously tracks patients’ movements, automatically categorizing blood pressure measurements as “awake” or “asleep”.” This innovation eliminates a key cause of false-positive ABPM results, and reduces sponsors’ dependence on patient diary data which are often unreliable.
“Blood pressure is now recognized as an important biomarker in the evaluation of cardiac risk,” said Cardiocore Chief Medical Officer, Lawrence Satin, MD, FACC. “Regulatory agencies are requiring a closer look at this biomarker within several therapeutic areas including diabetes, oncology and central nervous system. Addressing that need, we are pleased to partner with Tiba Medical, incorporating their top-quality technologies to help enable success in our clients’ clinical development programs.”
“Cardiocore’s scientific leadership and proven experience in managing trials from Phase I to Phase IV, make them an ideal partner to deploy our blood pressure monitoring platform,” said Tiba Medical President and Chief Executive Officer, Mr. Merat Bagha. He continued, “Cardiocore’s study management teams provide global provisioning, site support and blood pressure data management incorporated with their other centralized cardiac testing modalities such as electrocardiography (ECG) and echocardiography (ECHO).”
For additional information and to obtain a detailed proposal for an upcoming trial involving blood pressure data management services, contact a Cardiocore’s business development representative in the US, Europe or Asia respectively.
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