US Cardiac Safety Firm, Cordium Links First to Introduce Core Lab Services to China
Published: Jun 16, 2008
The joint venture, called Lawke Links, represents the first effort to bring a full range of ECG core lab services including project management, site support and centralized ECG data analysis to China. Lawke Links will provide FDA and ICH compliant cardiac safety analysis to biopharmaceutical companies conducting phase I - phase IV multinational clinical trials.
“We believe our drug development sponsors who are conducting clinical research in China will appreciate having state-of-the-art core lab services in country,” said Cordium Links CEO Kurian Abraham, MD. “With infrastructure and expertise ready and available, we will be able to save companies significant time and money while providing them with more options.”
Lawke Links’ will donate 9 percent of the value of work performed on all its contracts through June of 2009 to support the reconstruction and humanitarian efforts associated with the China Earthquake.
In addition to ECG core lab services, Lawke Links has established an exclusive relationship with Peking Union Lawke Biomedical Development Limited (PUL) to provide central lab services.
Dr Jian Ho, M.D., Ph.D, CEO and medical director at PUL initially will head up project management and site support for Lawke Links in China.
“It’s an honor to bring the resources of one of the leading core labs in the world to China,” said Dr. Ho “We will be the first and only lab that provides a full range of core lab and central lab services to the growing Chinese market.”
China represents one of the world’s fastest growing markets for clinical trials. The Tufts Outlook 2007 report forecasts that in three years up to 65 percent of FDA regulated clinical trials for top pharmaceutical companies will be conducted abroad. Also according to the Tufts Center for Drug Development, the market for clinical trials in China has grown 43 percent in the last 3 years.
ECG core labs today supporting clinical trials in China typically send equipment and technical expertise, which adds time and expense. Sponsors often must pay for the use of equipment shipped to China until it is returned. Lawke Links will offer all the advanced services that Cordium Links provides its US customers today, including 12-lead digital ECG, Holter monitoring, centralized data management and QT/QTc analysis and reporting to its customers who are conducting multinational clinical trials in China. As an “in country” core lab, Lawke Links will eliminate the difficulty sponsors currently face in sending equipment and locating expertise for every clinical trial conducted in China.
Representatives of Lawke Links will be present at the Drug Information Association (DIA) annual meeting in Boston, MA, June 22-26 2008, at Cordium Links booth #1756.
About Cordium Links Cordium Links (www.cordiumlinks.com) is a global provider of centralized cardiac safety data monitoring. Located in North Carolina, Cordium Links offers full service cardiac data monitoring for all phases of clinical trials. With a focus on training and protocol specific needs, Cordium Links provides a new alternative to other ECG Core Laboratories.
About Peking Union Lawke Biomedical Development Limited (PUL)
PUL (www.lawke.com), located in Beijing, is a leading central laboratory in China that provides both clinical trial testing and diagnostic testing services, including clinical and anatomic pathology. PUL is partially owned by Peking Union Medical College & Chinese Academy of Medical Sciences, the most prestigious biomedical institution in China and directly managed by MOH. In January of 2008, PUL established an exclusive relationship with PPD, Inc. (Nasdaq: PPDI) providing biopharmaceutical clients with a full range of highly customized central lab services in China.