January 28, 2008
The Colorado Prevention Center Achieves Mortara Certified Partner Status, Enhancing the Services Offering Of Their Healthcare Discoveries Inc. Central ECG Laboratory Services Partnership
Milwaukee, WI, January 28th, 2008 - Colorado Prevention Center (CPC) and Healthcare Discoveries Inc. (HCD) who together provide innovative central electrocardiography (ECG) laboratory services, announce that the CPC has achieved Mortara Certified Partner status after successfully implementing Mortara’s 12-lead Surveyor Telemetry System in Phase I studies. The CPC has been awarded these designations by Mortara as a result of the HCD and CPC collaboration designed to significantly advance cardiac safety in drug development through a seamless integration between the two organizations.
The Mortara Certified Partner Program recognizes cardiac central laboratories and academic institutions engaged in the analysis and annotation of digital ECG data. In collaboration with the U.S. Food and Drug Administration (FDA), Mortara has developed the E-Scribe ECG Warehouse, to receive, store and analyze cardiac safety data submitted in standardized data formats in support of New Drug Applications (NDAs). ECG data must pass a validation step in the E-Scribe ECG Warehouse system, to ensure adherence to the Health Level 7 (HL7) XML standard. FDA reviewers use the data warehouse system to process ECG data with advanced tools and viewing technologies.
As a result of the certified partner status and implementation of the 12-lead Surveyor Telemetry System, sponsors can be assured that when working with HCD Inc. and CPC, ECG data will be acquired with optimized workflow and real-time monitoring of signal quality. HCD Inc. and CPC investigators apply uniform diagnostic standards when interpreting ECGs. “We are excited that our partner, CPC, has be accepted into this ’elite club’ of ECG data providers. This enables us to optimize safety while providing our Sponsors with high quality data and cost effective clinical solutions that they have come to expect from our organizations” said Dr.
Dennis Ruff , President of Healthcare Discoveries Inc. “The HCD/CPC model is a great example of the tight integration that is available between the CPU and the ECG core lab with the Mortara platform. The acquisition to analysis times that are possible with the implementation between these two organizations should provide the metrics sponsors would like to see for important studies.” commented Mark Mentzer, Vice President, Clinical Trials for Mortara Instrument.
Evan King , Chief Operating Officer of the Colorado Prevention Center noted, “We have now positioned ourselves to present Sponsors with a complete turn-key solution for cardiac monitoring that streamlines the management of ECG data from site acquisition all the way to FDA submission. Mori Krantz MD, a cardiologist and ECG core lab medical director at CPC added, “because we have extensive experience conducting cardiovascular trials ECG core laboratory services are a natural fit. Our goal is to enhance safety in new drug development by providing rigorous, high-quality interpretation and analysis focused on differentiating signal from noise.”.
About Healthcare Discoveries Inc.
Established in 2000, Healthcare Discoveries Inc. (www.healthcare-discoveries.com) is a wholly-owned division of Catalyst Pharma Group, Inc (www.catalystpharmagroup.com
). HCD is composed of an industry dedicated Phase I/IIa facilitiy, with >115 bed (semi-private rooms) capacity, located in San Antonio, TX. Integrated services at Healthcare Discoveries Inc. include: clinical development plan preparation, project management, regulatory document preparation, safety surveillance, clinical monitoring, data management, statistical analysis, medical writing, quality assurance auditing, and regulatory submissions.
US Contact Richard Anthony, PhD, 626-568-8645 x112
UK/EU Contact Kerry Dyson , +44 (781) 4930601
About Colorado Prevention Center
The Colorado Prevention Center is an Academic Research Organization (ARO) dedicated to improving health by conducting clinical research and integrating scientific findings into the practice of preventive medicine. As an ARO, CPC provides trial management services that support every aspect of clinical research, including study design, biostatistics and data management, comprehensive trial management, specialized endpoint evaluation services, and completion of final study reports. The CPC is an affiliate of the University of Colorado Denver.
Contact Evan King: (303) 860-0712 x134
Mortara Instrument's headquarters are located in Milwaukee, Wisconsin, with European operations based in Bologna, Italy. Mortara Instrument is distinguished in the field of non-invasive cardiology innovations that are the core of the company's complete line of ECG products including ECG systems, stress exercise systems, Holter systems, data warehousing solutions, and cardiology monitoring systems. The company's website is www.mortara.com