Mortara Instrument Announces Collaboration with US Food and Drug Administration (FDA)
June 08, 2004
MILWAUKEE, WI USA
Mortara Instrument, Inc. today announced an agreement with the FDA to collaborate on a digital data warehouse which will facilitate review, analysis and archival of cardiac safety data submitted as part of new drug applications. The data warehouse is expected to process electrocardiographic (ECG) data and provide tools for FDA reviewers to manage, review, and analyze submitted datasets more efficiently.
The development effort will involve Mortara Instrument personnel in collaboration with FDA's Center for Drug Evaluation and Research (CDER) senior scientists. Development of the ECG data warehouse will utilize core technologies from Mortara’s E-Scribe Rx ECG data management system and will incorporate new features to facilitate specific FDA submission, review and warehousing requirements. These requirements include native support of the new HL7 XML “Annotated ECG” waveform and annotation standard used to submit ECG data to the FDA.
Mortara Instrument’s ECG data management technology will allow the ECG warehouse to integrate seamlessly with existing E-Scribe Rx systems or function as a standalone ECG repository. The FDA ECG warehouse architecture will be scalable to support the high volume requirements anticipated by the Agency as substantial amounts of digital ECG data are submitted throughout all phases of drug development. The warehouse will feature tools for dataset import and format validation; web-based query and review of ECG data with associated annotations; scoring systems for rank ordering ECG records and studies of interest; and advanced tools for research-oriented analysis and display of ECG data.
Development of the FDA ECG warehouse will proceed under a Cooperative Research and Development Agreement (CRADA) recently executed between Mortara and the FDA. “The CRADA process provides a unique opportunity for Mortara to work directly with the FDA in the establishment and continuing development of the ECG warehouse.” commented Justin Mortara, Ph.D., Vice-president, Sales and Marketing for Mortara Instrument. “The result will be a solution which is not only useful for FDA reviewers, but a spectrum of other parties concerned with cardiac safety data collection, analysis and submission, now and in the future.”
Mortara Instrument's headquarters are located in Milwaukee, Wis., 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 electrocardiographs, stress exercise systems, Holter systems, data warehousing solutions, and cardiology monitoring systems. The company's website is www.mortara.com