Gentiae Clinical Research Inc, a premier provider of centralized cardiac safety monitoring, data acquisition, global logistical services, clinical measurements and analytical services, has launched LifeSignals at the SRI "Outsourcing of Clinical Drug Development" Conference. The SRI Conference is taking place September 22-24 in Scottsdale, Arizona.

Gentiae manages the collection, measurement, clinical interpretation, analysis, archiving and submission of digital ECG and cardiac safety data through its LifeSignals platform technology, 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.

"The LifeSignals platform technology for digitally collecting, transmitting and analyzing ECGs and other physiological data provides a well-defined and manageable system for our clients, who have multiple large scale studies being conducted simultaneously on a global scale," said Polina Voloshko, Vice President of Gentiae's Cardiovascular Clinical Services department. "LifeSignals has been validated, both technically and scientifically, to meet the requirements of the new regulatory guidelines."

To date, Gentiae has been engaged by a number of leading pharmaceutical and biotechnology companies, including four of the top 40 pharmaceutical companies, as well as one of the world's largest biotechnology companies, to provide centralized electrocardiography (ECG), Holter, echocardiography (ECHO) and angiography acquisition and analysis services, as well as other imaging services including magnetic resonance imaging (MRI), computed tomography (CT), and positron emission tomography (PET). In one recent study, Gentiae completed a Phase I study for a major pharmaceutical company using the LifeSignals system to review more than 14,000 ECGs in 45 days.

The FDA regulatory guidance stems from the November 2002 ECG Concept Paper developed jointly by the FDA and Health Canada. The ECG Concept Paper has undergone the first step process to meet the International Conference on Harmonisation guidelines. The rapidly evolving guidance requires all new drug candidates to undergo a well-defined and thorough Phase I ECG Study, which is to be conducted by an ECG core or central laboratory, such as that offered by Gentiae. The guidance further states that ECG interval duration measurements defining cardiac parameters should be performed manually, with ECGs interpreted by designated cardiologists.

The impact of the FDA-Health Canada guidance will be a dramatic increase in the number of ECGs collected in Phase I studies. Traditionally, the accumulated Phase I studies for a new compound included fewer than 1,000 ECGs in total. Under the new guidelines, a thorough Phase I ECG Study may entail more than 150 subjects and collection of at least 5,000 to 15,000 ECGs. Previously, more than 90% of ECGs collected in clinical trials were analyzed at the investigative site, which makes it difficult to reproduce the results. To ensure consistent evaluation and reproducibility of cardiac safety, the guidance provides for ECGs to be analyzed by a core or central laboratory utilizing a validated, digital process that enables manual interval duration measurements and rapid turnaround.