Cardiocore, a US-based cardiac core lab and Tiba Medical, a blood pressure monitoring technology provider, have formed alliance delivering advanced blood pressure monitoring solutions for both cardiac safety and efficacy clinical trials.
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. The company claimed that the solutions comprise a family of ambulatory, office and home blood pressure monitoring devices including Tiba Medical’s 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 an actigraphy system.
The technology continuously tracks patients’ movements, automatically categorizing blood pressure measurements as ‘awake’ or ‘asleep’. The innovation eliminates a key cause of false-positive ABPM results, and reduces sponsors’ dependence on patient diary data which are often unreliable.
Lawrence Satin, chief medical officer of Cardiocore, said: “Blood pressure is now recognized as an important biomarker in the evaluation of cardiac risk. 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.”
Merat Bagha, president and chief executive officer of Tiba Medical, said: “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.
“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).”