SAN FRANCISCO and WASHINGTON, June 27 /PRNewswire/ -- Gentiae Clinical Research, Inc., a premier provider of centralized cardiac safety monitoring and imaging services announced today the completion of a Thorough QT study for a leading biotechnology company. Gentiae was retained as the single, comprehensive source for all aspects of the study, including study design, protocol writing, site selection and qualification, clinical laboratory coordination, clinical monitoring, data integration, electronic data capture, and report writing for regulatory submission.
Gentiae is showcasing the Turn-key QT Solution at the 41st annual Drug Information Association (DIA) meeting held in Washington, D.C. June 26 - 30, 2005.
"Gentiae initiated the Phase I Thorough QT study for a prominent biotechnology company, starting with the design of the protocol," said Polina Voloshko, M.D., vice president of Cardiovascular Clinical Services. "The protocol was prepared, including all aspects of the statistical -- clinical design of the study, and returned with the FDA's regulatory review and comments within 6 weeks time, start to finish."
Gentiae was commissioned to select a Phase I facility and to provide the clinical monitoring services, along with trial management and project management for all aspects of the study. Gentiae also provided the clinical database, electronic case report form, randomization schedule, electrocardiograph equipment and supplies, and then performed the rigorous ECG analysis for a four-period, four-sequence, cross-over study in accordance with the protocol specifications. Gentiae's data management team performed the query resolution and provided the final database using the LifeSignals(TM) technology platform. Working in concert with the Phase I facility, Gentiae met or exceeded all timelines and expectations, and the client was able to expedite its FDA submission schedule accordingly.
"The comprehensive solution fills a need for sponsors that, for various reasons, do not have the internal resources to manage such a complex, highly specialized project," said Michael Kokesh, president and chief executive officer. "Gentiae is uniquely equipped to manage this type of quick turn Phase I study, providing superior service and technology in a comprehensive manner to achieve significant cost savings for our valued clients."
"The FDA evaluates ECG data based upon how reproducible, or consistent it is," said Dr. Voloshko. "Gentiae's consistency is achieved by rigorous SOP driven, internal quality control procedures, training and continuous monitoring of the annotations performed by our team of experienced physicians. Most of our physicians have been with us -- beginning with our origins at a leading academic medical center -- for 12 years or more. As illustrated with this particular Thorough QT study, we were able to accomplish the client's objectives and satisfy the regulatory requirements using a smaller patient population and fewer ECGs, but with sufficient statistical power because Gentiae's reproducibility rate is so high."
Gentiae's emphasis on quality and the reproducibility of results translates into a significant cost savings to our valued clients. To learn more about Gentiae's comprehensive approach to providing superior service and technology, please contact Kristin Tedesco, Manager, Business Development, or contact Dr. Voloshko directly at 650-808-2318 for a consultation.
Gentiae Clinical Research, Inc., based in the San Francisco Bay Area, is a premier provider of quality cardiovascular core laboratory and clinical development services for the pharmaceutical, biotechnology and medical device industry. As a spin-off from the Ischemia Research and Education Foundation, Gentiae inherits more than 18 years of experience interpreting cardiac safety data. Gentiae conducts research worldwide and provides a 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. The name Gentiae, based on a Latin root, means "people of the world."
Gentiae Clinical Research, Inc.