Tiba Medical and Spaulding Clinical Research Team Up to Bring Blood Pressure Monitoring to Phase I Cardiac Safety Clinical Trials

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July 2, 2009 - Milwaukee, WI – Tiba Medical and Spaulding Clinical Research announced today an important collaboration for supporting Phase I cardiac safety clinical trials.




As part of this strategic agreement, Spaulding Clinical Research has integrated Tiba Medical’s Ambulo 2400 ambulatory blood pressure monitoring (ABPM) systems into its suite of offerings.    In this way, clinical trials that need to review blood pressure as a cardiac safety biomarker can now obtain, acquire, analyze, and report findings seamlessly.  The ambulatory device and related software will greatly simplify and improve the frequent acquisition of blood pressure data in varying activity states.  The completed solution will allow pharmaceutical companies and their Clinical Research Organization (CRO) partners to accomplish the following objectives:


  • Design and manage a stringent protocol for cardiac safety monitoring using a state-of-the-art Clinical Trial Management System
  • Obtain, analyze, review, and report critical clinical safety biomarkers—including blood pressure—for each subject in a Phase I environment
  • Correlate ECG data (e.g., ST segment shifts) with blood pressure data at perfectly synchronized time points
  • Perform chronologically precise correlations of physiological parameters (e.g., electrocardiographic QTc or blood pressure) with plasma concentration for PK/PD modeling
  • Warehouse all data and provide near real-time results for review by sponsors and safety experts, and
  • Utilize a solution that is validated and complies with the FDA’s 21 CFR Part 11 criteria for electronic records

“In our continuing pursuit to move the science of cardiac safety studies into the 21st century, it is important to offer our clients the ability to collect blood pressure as an added cardiac safety biomarker,” said Randy Spaulding, founder of Spaulding Clinical Research.   “By incorporating Tiba Medical’s ABPM systems, we are able to offer our clients a state-of-the-art solution that seamlessly integrates with our overall services.”

“The FDA and other regulatory agencies are continually assessing various biomarkers and surrogates as part of the risk/benefit evaluation of new drugs.  Changes in blood pressure induced by new drugs are now recognized as an important consideration for increased cardiovascular risk” said Merat Bagha, President and Chief Executive Officer of Tiba Medical.  “We are pleased to partner with Spaulding Clinical Research to provide a seamless, integrated, and ready-to-go platform for better assessing cardiac safety” said Mr. Bagha.



The combined solution will be available directly from Spaulding Clinical Research to biopharmaceutical customers and their CRO partners in July 2009.



About Spaulding Clinical


Based near Milwaukee, WI, Spaulding Clinical Research (www.SpauldingClinical.com) is a Phase 1 Clinical Research Unit and Cardiac Core Lab, offering a range of services including definitive QTc (TQT) studies, first-in-human studies, multiple rising dose, bioavailability and bioequivalence, drug interaction, food effect, and PK/PD characterization. Spaulding Clinical also offers a full suite of Cardiac Core Lab and over-reading services with state-of-the-art technology and cardiac expertise.

About Tiba Medical

Based in Portland, Oregon, Tiba Medical offers innovative and affordable hypertension diagnostics solutions.  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.  For more information about Tiba Medical and its products please visit our web site at www.tibamedical.com

 

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