Cardiocore

Cardiocore CMO Presents at 2nd DIA Cardiac Safety Workshop in Japan

PMDA and Global Experts Discuss Implementation of ICH-E14 in Japan
 

Washington, DC — Cardiocore, a premier centralized cardiac testing lab, announced today that its Chief Medical Officer, Lawrence Satin, MD, FACC, presented an advanced method to manage heart rate changes’ effect on QT assessment at the 2nd DIA Cardiac Safety Workshop in Japan, in Tokyo, on September 6, 2011.


Dr. Satin’s presentation featured a high-level modification of the Holter Bin methodology that successfully distinguishes QT changes that are caused by non-dangerous heart rate variations from QT changes that are caused by potentially fatal ion channel blockade. This approach has proven has been accepted by global regulatory bodies, enabling a smooth clinical development process for drugs that would otherwise have been slowed by a false positive Thorough QT study.


In annual this meeting of PMDA regulators, academicians, Japanese pharmaceutical company representatives and clinical pharmacology professionals, Dr. Satin also participated in an expert panel discussing “How TQT Studies May be Made More Efficient?”


More details about this key industry conference may be accessed through Cardiocore’s web site at http://www.cardiocore.com/news/events.


 
About Cardiocore: Cardiocore has provided superior centralized cardiac testing services to the pharmaceutical industry for 17 years. Services include centralized electrocardiography (ECG), Holter monitoring, echocardiography (ECHO), multigated acquisition scans (MUGA), protocol development and statistical analysis. The company is experienced in cardiac safety and efficacy testing in Phase I-IV and Thorough QT clinical trials. These services are supported by the company’s advanced data management system featuring the proprietary HolterGateway™ and CardioPortal™. Cardiocore headquartered in Bethesda, Maryland, with offices in South San Francisco, California, London, England and Singapore. www.cardiocore.com



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