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Mortara Instrument Launches
E-Scribe Rx for Clinical Trial ECG Data Management
System provides
multi-protocol support, 21 CFR Part 11 compliance, and optional modules
to support proposed FDA submission guidelines for ECG.
MILWAUKEE, WI, USA
16 July 2002
Today Mortara
Instrument announced the launch of its
E-Scribe Rx ECG Data Management
System.
Built upon the Mortara E-Scribe ECG Data Management System, the E-Scribe
Rx provides important additional functionality to facilitate work flow
and to meet regulatory requirements associated with electronic data
collection and management for clinical research trials. The E-Scribe Rx
is the only ECG data management system that provides multi-protocol
support, 21 CFR Part 11 compliance and a suite of optional modules to
support the proposed FDA submission guidelines.
The E-Scribe Rx data management system provides for support of up to 256
simultaneous protocols. Each of the independent protocols can be
configured with different Custom ID settings for each trial. Using
Custom ID allows for user-defined demographic fields to be managed
within the E-Scribe Rx system and downloaded into various ECG
acquisition devices. Demographic field labels can be defined to match
the terminology utilized by any particular trial. This reduces
demographic data entry error and the operating costs associated with
querying investigative sites after receiving incomplete or inaccurate
data entry on ECG records. Commenting on this new feature for E-Scribe
Rx, Mark Mentzer, Director of Marketing said, “Understanding the need to
provide unique demographic fields for each protocol and the fact that
ECG core laboratories can have scores of trials running simultaneously
all over the world led us to the clear conclusion that the E-Scribe Rx
should support an expanded number of total protocols.”
In addition to the expanded protocol support, the E-Scribe Rx has been
designed specifically to facilitate 21 CFR Part 11 compliance.
Significant elements of the system have been enhanced to provide for
tighter security as well as extensive audit trails. Passwords are
automatically aged, all ECG record transactions are logged, and
electronic signatures are enforced. A complete record of changes is
maintained and can be accessed simply for any individual record. All ECG
record changes are referenced to the previous record and the authorized
person who made the change is indicated along with when and why the
change was made. “Compared to the standard requirements for a hospital
information system workflow, 21 CFR Part 11 represents a whole new
world,” said Mark Mentzer. “Hospital-oriented ECG data management
systems do not generally meet the Part 11 requirements and hence their
utility for collecting digital data in clinical trials is somewhat
limited.”
With optional modules including the 12XML export module and the Digital
Measurement and Annotation (DMA) module, the E-Scribe Rx can be
configured to be a complete solution for ECG acquisition, global
transmission, storage, measurement, annotation and export. These
modules, which are based on the proposed FDA ECG format, will provide
ECG core laboratories and sponsors with the tools and data format to be
in compliance with the final guideline provided by the FDA. Barry Brown,
Product Integration Manager for Mortara Instrument and participating
author in the draft format document commented, “Many of our recent
product developments have taken advantage of XML technology. We have
been actively participating in the development of the FDA XML ECG format
and will work closely with our customers to insure a smooth transition
once the final XML format is defined.”
About Mortara
David W. Mortara, Ph.D., one of the
world’s leading figures in ECG algorithm development, founded Mortara
Instrument in 1982. 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 for the innovations that are the core of the company's
complete line of ECG products. These product innovations include the
integration of 12-lead ECG technology in bedside monitoring, wireless
stress testing, Holter and telemetry monitoring
systems. The company's website is www.mortara.com
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