March 09, 2007
Mortara Announces CardiaBase Certified Partner Status
CardiaBase Data Formatting Is Compliant with HL7 Version 3 Annotated ECG Standard
Nancy, France – March 2, 2007 - CardiaBase, which provides central reading of cardiac data (ECGs and Holters), in order to assess the cardiac consequences (side effects) of new drugs, announced today the successful completion of Mortara Instrument’s Certified Partner Program. This certification provides sponsor organizations with the assurance that data sets produced by CardiaBase will be ready to upload into the E-Scribe ECG Warehouse for sponsor or FDA review.
“CardiaBase has always paid particular attention to its compliance with regulatory requirements and IT systems. This certification is yet another security for sponsors who need high-value ECG services in Phase I clinical trials” Pascal Voiriot, CEO for CardiaBase, said.
The Mortara ECG Warehouse was developed by Mortara in collaboration with the Food and Drug Administration (FDA) to act as a repository for annotated electrocardiographic (ECG) studies provided to the FDA in support of new drug applications. The system is designed to be used by FDA reviewers to process ECG data with advanced tools and viewing technologies based upon Mortara’s E-Scribe Rx product and VERITAS™ ECG algorithms.
CardiaBase SAS is headquartered in
Nancy, France . CardiaBase is specialising in central reading of cardiac data with a particular focus on Phase I studies, representing 90% of its activity. The company has developed specific measurement methods that brings unequalled accuracy and allow optimizing the volunteers sample size. The company website is www.cardiabase.com .
Mortara Instrument headquarters are located in Milwaukee, Wis., with European operations based in
Bologna, Italy . Mortara is distinguished in the field of non-invasive cardiology innovations that are the core of its complete line of ECG products including electrocardiographs, stress exercise systems, Holter systems, data warehousing solutions, and cardiology monitoring systems. The company website is www.mortara.com.