SAN FRANCISCO and WASHINGTON, June 24 /PRNewswire/ -- Gentiae Clinical Research, Inc., a premier provider of centralized cardiac safety monitoring, analysis and global logistical services, announced today the addition of the Enterprise ECG Solution (EES) to its LifeSignals(TM) technology platform. LifeSignals(TM) provides the first comprehensive, fully integrated suite of technology and clinical services for digital acquisition, centralized analysis, archival storage and enterprise-wide management of ECG waveforms in XML format, as well as other forms of cardiac safety data.
Gentiae showcased the LifeSignals(TM) Enterprise ECG Solution at the 40th annual Drug Information Association (DIA) meeting held in Washington, D.C., June 13-16, 2004.
Accumulation of ECG data in the clinical development process is an essential factor for every pharmaceutical and biotechnology company today. The success of such research and development oriented companies depends on their ability to protect, preserve, and manage the ECG data in a manner that is not only efficient and reliable, but one that ensures compliance with both regulatory and corporate polices. In addition, recently proposed FDA guidelines require all new drug candidates to undergo more rigorous Phase I ECG studies conducted by a centralized laboratory using validated, digital analysis of ECG waveforms. To meet these new requirements, pharmaceutical and biotechnology companies require comprehensive, enterprise solutions for acquisition, analysis, storage and management of ECG data. Gentiae's LifeSignals(TM) Enterprise ECG Solution allows these companies to focus on their core competencies while Gentiae's enterprise-level technology provides the necessary data storage, archival and management solutions with fully compliant data protection and reporting to meet the latest federal and international regulations.
The LifeSignals(TM) Enterprise ECG Solution provides comprehensive data storage and management capabilities including data backup and recovery, managed data archiving and retrieval, and integration with existing mass storage systems -- all in a customized, Web-based ASP platform. The LifeSignals(TM) EES data repository can be integrated with existing digital data acquisition and analysis processes, providing immediate access to datasets across multiple clinical trials. By making these datasets accessible for retrospective analyses and correlation studies, LifeSignals(TM) EES allows drug development enterprises to derive added value from accumulated ECG studies to make more informed clinical development decisions.
"There are a multitude of benefits that our clients should realize from using the LifeSignals(TM) ECG Enterprise Solution," explained Michael Kokesh, Gentiae's president and chief executive officer. "These benefits include reduced costs for ECG collection, storage and management; integration and long-term storage of digital ECG data in a searchable enterprise repository; automated data management and sophisticated data mining and analysis." Mr. Kokesh added, "We are committed to providing our clients with customized, comprehensive clinical trials solutions through applications of our technology and the 24/7 support of our expert clinical staff. The addition of the Enterprise ECG Solution to our LifeSignals Portal is part of this continuing commitment."
With the added ECG data warehousing capabilities, the LifeSignals(TM) Platform provides the first fully integrated suite of technology and clinical services for cardiac safety monitoring, including expert, centralized data analysis. As a recent spin-off from the Ischemia Research and Education Foundation, Gentiae's ECG central laboratory inherits more than 17 years of experience interpreting cardiac safety data for global studies. Gentiae utilizes rigorous training, internal quality controls and proven analysis methodologies to ensure the highest reproducibility rate in the industry. In addition to ECG services, Gentiae also provides centralized core laboratory services including Holter, echocardiography, angiography, PET, MUGA and CT analysis.
"Our portfolio of technology and services provides the most adaptable and robust system for digitally collecting, transmitting, analyzing and managing cardiac safety and imaging data in current studies," remarked Polina Voloshko, M.D., Gentiae's vice president of Cardiovascular Clinical Services. "The LifeSignals(TM) System allows our clients to more efficiently and reliably protect, preserve and manage valuable ECG data by partnering with Gentiae's unsurpassed expertise in cardiovascular clinical trials."
LifeSignals(TM) EES is a complete enterprise solution, custom-designed for total, seamless integration with each client's internal and external processes and existing data collection and management systems. From emerging biotech companies in early-phase trial to large pharmaceutical firms with multiple worldwide studies, LifeSignals(TM) provides Gentiae's clients flexibility in obtaining logistic services, site support, data collection and trial management services. The system's ease of use is complimented 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.
Gentiae Clinical Research, Inc., based in San Francisco, is a premier provider of quality clinical development services for the pharmaceutical, biotechnology and medical device industry. Gentiae conducts research worldwide and 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) System, a customized suite of technology and clinical services designed to meet the requirements of global regulatory authorities, including the U.S. Food & Drug Administration's emerging international regulatory guidance and technical standards.
Gentiae Clinical Research, Inc.