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GENTIAE Clinical Research Adds Powerful Enhancements To LifeSignals(TM) System


10/19/2005 5:09:48 PM

SAN FRANCISCO and LAS VEGAS, Jan. 26 /PRNewswire/ -- Gentiae Clinical Research, Inc., a premier provider of centralized cardiac safety monitoring, global logistical services, and analytical services, announced today further enhancements to its LifeSignals(TM) System. The LifeSignals(TM) technology platform provides a fully integrated infrastructure for digital acquisition, centralized analysis and near real-time reporting of ECGs, diagnostic images, and other forms of cardiac safety data.

Gentiae will showcase the LifeSignals(TM) enhancements at the upcoming conference, "Partnering With Central Labs, ECG and Imaging Core Labs," taking place January 26-28 in Las Vegas, Nev. Demonstrations of the LifeSignals(TM) System will be hosted at Gentiae's booth at the conference.

One of the key enhancements to the LifeSignals(TM) System provides Gentiae's clients with access to important cardiac safety information and other trial data through a secure Internet portal. Companies sponsoring clinical trials, as well as the principal investigators at individual research sites around the world, will have next to real-time access to customized information and reports instead of waiting hours, days or months for the information to become available to them. By automating formerly manual processes, many time consuming steps are streamlined and opportunities for error are eliminated through the use of the LifeSignals(TM) System.

"We will customize a LifeSignals(TM) solution for each of our clients, depending on size and scope of the project," said Lu Lyons, Director of Clinical Data Sciences at Gentiae. "We are demonstrating a total commitment to our clients, through customized clinical trials solutions, applications of technology and the availability of expert staff on a 24/7 basis. The new LifeSignals(TM) Internet portal is an extension of our technology commitment to our clients."

"We believe it is the most adaptable and robust system for digitally collecting, transmitting and analyzing cardiac safety and imaging data," added Michael Cheung, Director of IT Services at Gentiae. "Through the LifeSignals(TM) System, we provide our clients with around-the-clock access to important cardiac safety data."

Gentiae specializes in providing customized solutions for each client and each clinical trial. Whether an emerging biotech with an early-phase product or a large pharmaceutical firm with multiple worldwide studies, LifeSignals(TM) was developed to provide Gentiae's clients flexibility in obtaining logistic services, site support, data collection and trial management services. The system's ease of use is complemented by technology for the digital acquisition, centralized analysis and near real-time reporting of ECGs, diagnostic images, and other forms of cardiac safety data. LifeSignals(TM) accommodates both paper and electronic reporting and provides multiple means of data transfer. Through the use of the LifeSignals(TM) System Gentiae's clients are fully capable of meeting the requirements of global regulatory authorities including the FDA's emerging international regulatory guidance and technical standards.

The increased importance of cardiac safety in all phases of drug development, not just in Phase I testing, provided the impetus for developing the LifeSignals(TM) System. "We launched the LifeSignals(TM) technology platform in October 2003 and received immediate acceptance from our existing clients and substantial interest from potential clients," said John Costello, Director of Sales and Business Development at Gentiae. "Using LifeSignals(TM) Gentiae recently reviewed more than 14,000 ECGs in 45 days, completing a critical Phase I study for a major pharmaceutical client on time and on budget. LifeSignals(TM) supports inclusion of a more robust cardiac safety profile in all phases of the drug development process to ensure compliance with the proposed regulatory guidelines."

About Gentiae

Gentiae Clinical Research, Inc., based in San Francisco and conducting research worldwide, is a premier provider of quality clinical development services for the pharmaceutical, biotechnology and medical device industries. Gentiae provides a full 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. The cardiovascular core laboratory services include echocardiography, ECG, Holter, CT, PET, MUGA and angiography. Gentiae manages the collection, measurement, clinical interpretation, analysis, archiving and submission of digital ECG data and diagnostic images through its LifeSignals(TM) technology platform, a customized technology and process designed to meet the requirements of global regulatory authorities, including the US Food & Drug Administration's emerging international regulatory guidance and technical standards.

Gentiae Clinical Research, Inc.

CONTACT: John Costello, Director, Sales and Business Development,+1-415-715-2326, or fax, +1-415-715-2307, or jpc@gentiae.com, or Lu Lyons,Director, Clinical Data Sciences, +1-415-715-2308, or lal@gentiae.com, both ofGentiae Clinical Research, Inc.; or Julie Chase, cell, +1-415-710-7108, orjchase@chasepr.com, or Angelyn Lechman, cell, +1-858-337-9603, orangelynl@yahoo.com, both of Chase Communications, +1-415-433-0323, for GentiaeClinical Research, Inc.


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