June 14, 2010 – 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.
Cardiocore (www.cardiocore.com) has provided superior centralized cardiac testing services to the pharmaceutical industry for 18 years. Services include centralized electrocardiography (ECG), Holter monitoring, echocardiography (ECHO), multigated acquisition scans (MUGA), protocol development and statistical analysis. The company is experienced in cardiac safety and efficacy testing in Phase I-IV and Thorough QT clinical trials. These services are supported by the company’s advanced data management system featuring the proprietary HolterGateway™ and CardioPortal™. Cardiocore headquartered in Bethesda, Maryland, with offices in South San Francisco, California, London, England and Singapore.
About Tiba Medical
Tiba Medical (www.tibamedical.com) is a leader in the field of blood pressure monitoring solutions. Tiba Medical’s flagship Ambulo 2400 ABPM system offers innovative features which set it apart from the current standard. Combined with best-of-breed office and home blood pressure monitoring solutions, as well as FDA 21 CFR Part 11 validated web platform, Tiba Medical’s BP-EDC solution offer a level of innovation, scalability and reporting which ensures better compliance by subjects and sites, and better overall results for a study. Tiba Medical is an FDA-registered establishment and certified to be compliant with the ISO 13485:2003, acknowledging that Tiba Medical meets quality system requirements that are recognized across the world. With offices in Portland, Oregon, Tiba Medical’s products are currently marketed in the US, Canada, Europe, Asia, Latin American and Africa.