|
 News
Releases
|
|
Key
Scientists at eResearchTechnology, Mortara
Instrument, and
AMPS receive Food and Drug Administration’s Commissioner’s
Special Citation Awards for Important Contributions in the ECG Waveform
Standards Development
The standard will provide for regulatory submission of annotated ECG
data to help
meet the FDA’s need to assess the Cardiac Safety of New Drugs
Philadelphia, PA, Milwaukee, WI, New York, NY, USA
10 October 2003
The Commissioner of the Food and Drug
Administration has awarded a Special Citation to key scientists at
eResearchTechnology, Inc. (eRT), (NASDAQ: ERES), Mortara Instrument,
Inc. and A.M.P.S, LLC (AMPS), and others for providing invaluable
assistance to the FDA for the development of a format for regulatory
submission of digital annotated electrocardiograms (ECGs). The format
will be used by the FDA to determine the cardiac safety of new drugs.
The three companies have worked in close collaboration over the past 2
years to develop a seamless digital ECG solution for both standard
12-lead resting and 12-lead ECGs obtained by Holter monitoring. The
digital solution is the backbone of the central ECG services offered to
sponsors of clinical research to define the cardiac safety of their new
products. In recognition of this effort (along with other contributors),
Fabio Badilini of AMPS, Barry Brown of Mortara and Joel Morganroth, M.D.
of eRT each received the Special Citation Award.
Fabio Badilini, the founder of AMPS has been instrumental in providing a
free XML wave form viewer to allow anyone to image the ECG with the
annotations placed by the central ECG laboratory and has also developed
a full version software allowing for organization, identification and
specialized analyses of the large volume of ECGs from clinical trails
that will be submitted to the FDA. eRT is currently offering the AMPS
XML wave form viewer on its website and is the principal provider of the
software to the Pharmaceutical Industry.
Joseph Esposito, President and CEO of eRT, commented, “Dr. Joel
Morganroth, our Chief Scientist has guided the development of the
company’s technology and services that enable digital collection,
measurement, interpretation, reporting and storing of the digital ECGs
that are used to define new drug effects. eRT’s technology, global
operations and digital services, together with the technology developed
by Fabio Badilini at AMPS and the state of the art equipment from
Mortara, has enabled us to provide the best of class services to the
drug development industry. This combination of science, technology and
collaboration positions eRT to offer franchise agreements such as the
ones recently announced, that provide for capacity, compliance, and cost
efficiencies. We are proud that the FDA has chosen to recognize our
Chief Scientist, who is a respected international expert in the design
and interpretation of ECG trials, for his contributions in this area.”
“Mortara is pleased that it could provide its ECG technology expertise
to facilitate the development of this standard,” commented Justin L.
Mortara, Ph.D., Vice president of Mortara Instrument. “Mortara’s
involvement from the initial concept to balloting of the standard within
the HL7 organization resulted in an open standard that can be easily
utilized by medical device companies, core laboratories, sponsors and
the FDA. We are honored that Barry Brown, our Product Integration
Manager, was recognized for his leadership role as the primary
participant from the medical device industry. As a leader in the field
of ECG technology, Mortara is encouraged by the digital initiative
within FDA and the impact it will certainly have on the accumulation of
significant databases which in turn will help the world better
understand the nature of cardiac repolarization and the safety of new
drugs.”
About eResearchTechnology, Inc.
Based in Philadelphia, PA, eResearchTechnology, Inc. (www.eRT.com) is a
provider of technology and services to the pharmaceutical, biotechnology
and medical device industries on a global basis. The company is a market
leader in providing centralized core-diagnostic electrocardiographic (ECG)
technology and services to evaluate cardiac safety in clinical
development. The company is also a leader in providing technology and
services to streamline the clinical trials process by enabling its
customers to automate the collection, analysis, and distribution of
clinical data in all phases of clinical development.
About Mortara Instrument, Inc.
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
About A.M.P.S., LLC
Based in New York, NY, A.M.P.S., LLC provides integrated services in the
medical environment, specifically in the field of quantitative ECG
analysis and blood pressure monitoring. While tailoring its scientific
know-how to clinical trials, AMPS is utilized by Researchers,
Associations, and Institutions in the pharmaceutical-scientific
environment at large.
|
|
|
