08 August 2006, MILWAUKEE, WI USA, NEW YORK, NY USA - Mortara Instrument Inc and AMPS LLC agreed to cooperate in aligning the HL7 XML validation checks in a future version of the AMPS XMLFDA Viewer with those implemented in the Mortara ECG Warehouse. The Mortara ECG Warehouse, currently in use by FDA for the import, storage, review and assessment of annotated electrocardiographic (ECG) studies, was developed by Mortara under a Cooperative Research and Development Agreement (CRADA) to support the Food and Drug Administration in assessing the cardiac safety of new compounds submitted for approval. .
The Mortara ECG Warehouse requires all annotated datasets to meet the HL7 standard in order to be successfully imported into the warehouse. An import validation check is performed on each ECG upon upload. Any errors and warnings found in the import process are logged to report non-compliant elements and reasons for non-compliance.
The AMPS Viewer tool includes an independent HL7 syntax validation algorithm providing a verification of the annotated datasets at 4 different levels, addressing all issues related with the submission of the datasets into the FDA Warehouse.
By virtue of this agreement the two independent platforms will both produce, in the near future, a consistent set of syntactical warnings and error messages, during the validation phase prior to the submission to the FDA Warehouse. This software alignment will insure that all requirements embodied in the HL7 Schema and the HL7 Implementation Guide will be interpreted and flagged by the two products in the same fashion, thus giving a consistent interpretation of the HL7 annotated ECG standard requirements.
Justin L. Mortara, Ph.D., Vice President for Mortara Instrument commented, “Since the creation of the annotated ECG standard and the implementation of the ECG Warehouse in collaboration with the FDA, Mortara has worked closely with numerous Sponsors and ECG central laboratories to achieve consistent interpretation and implementation of the HL7 annotated ECG standard. The result today is that more than 250,000 annotated ECGs have been successfully imported into the ECG Warehouse, making them available for advanced web based review by both Sponsors and regulators using the Mortara VERITAS algorithm toolset. Alignment of the AMPS Viewer with the ECG Warehouse HL7 validation check will provide another mechanism for central laboratories and Sponsors to verify the syntax of their HL7 annotated ECG datasets prior to placement in the ECG Warehouse. This will further simplify the process of getting ECG datasets into the ECG Warehouse, which in turn will enable broader use of the Mortara ECG analysis and review tools developed under our CRADA with the FDA.”
Fabio Badilini, Chief Scientist at AMPS commented, “We are extremely happy of the fruitful cooperation we have developed with Mortara Instrument in the past years and this agreement confirms that both companies aim to enhance and facilitate the work to both FDA personnel throughout the review process and to sponsors who wish to enhance their cardiac safety assessment of new drugs".
Mortara Instrument, Inc, based in
Milwaukee, WI , is distinguished in the field of non-invasive cardiology for innovations that are the core of the company’s complete line of ECG products including electrocardiographs, stress exercise systems, Holter systems and data warehousing solutions, and cardiology monitoring systems. The company’s website is www.mortara.com.
AMPS Llc, based in
New York, NY , is a leading edge software company providing software solutions used specifically by Clinical Research Organizations and Pharmaceutical corporations in the field of quantitative ECG analysis and blood pressure monitoring. The company’s website is www.amps-llc.com.