Gentiae Completes Mortara Certified Partner Program for Digital ECG Submission to the FDA
January 05, 2006
SAN FRANCISCO, CA – Jan 5, 2005 –Gentiae Clinical Research, Inc. a provider of centralized cardiac safety monitoring & imaging services, announced today their participation in and successful completion of Mortara Instrument’s Certified Partner Program. This program rewards compliance to the HL7 annotated ECG standard required for submitting ECG datasets to the FDA. The datasets are routed through the ECG warehouse which was developed by Mortara in collaboration with the FDA.
Gentiae completed a four-week process in order to achieve the certification, based upon steps outlined in an implementation guide provided by Mortara. These steps included verifying that data in all required and optional fields were mapped correctly; validating sample annotated ECG files; and transferring test data.
"The significance of this step is that our Sponsors can be certain that their digital ECG submissions will be accomplished efficiently and with absolute data integrity," said Michael Cheung, director of IT at Gentiae. "It also demonstrates our dedication to keeping in compliance with the latest regulatory guidelines in order to add value as a service partner to our clients. Their critical cardiac safety data can now transfer seamlessly from our digital ECG management platform, LifeSignals™, to the FDA ECG warehouse."
"It was a pleasure working through this process with Gentiae," said Randy Spaulding, vice president of clinical research at Mortara. "Due to their in-house digital ECG technology platform and their IT professionals, the data transfers and validation steps went as smoothly as possible. We look forward to working together on their upcoming FDA client submissions."
Gentiae Clinical Research, Inc., based in the San Francisco Bay Area, is an internationally recognized provider of cardiovascular core laboratory services including electrocardiography (ECG), Holter, echocardiography (ECHO) and angiography. As a spin-off from the Ischemia Research and Education Foundation, Gentiae’s ECG central laboratory inherits more than 18 years of experience interpreting cardiac safety data for global studies. Gentiae conducts research worldwide and provides a range of clinical trial management services that include protocol design, trial management, project management, data management, site monitoring, biostatistical analysis, report writing, and regulatory support. Gentiae manages the collection, measurement, clinical interpretation, analysis, archiving and submission of digital ECG data and diagnostic images through its LifeSignals™technology platform.
The name Gentiae, based on a Latin root, means "people of the world." More information about Gentiae can be found at www.gentiae.com .