Company Milestones
1968
Cardiocore founder Lawrence Satin, MD, FACC worked with Norman Holter (inventor of the Holter Monitor) in the NASA space program studying the effects of space travel on astronauts. At that time, newly devised Holter recorders weighed 50 pounds and were outfitted in astronauts’ backpacks. From that innovative era until the present day, Dr. Satin’s research teams have always remained at the leading edge of Holter technology application.
1992
Central Cardiac Testing (CCT) was founded by Dr. Satin as one of the world’s pioneer cardiac core labs. CCT performed centralized cardiac testing studies for Top Ten, international pharmaceutical companies, and was the first core lab to deploy digital 12-Lead Holter recorders in a clinical trial.
2003
The Food and Drug Administration and Health Canada published the Guidance for Industry, E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. Immediately thereafter, Central Cardiac Testing transformed to Cardiocore, the first modern cardiac core lab designed to serve sponsors’ needs in the post-E14, digital ECG era.
2003
Cardiocore launched the CardioPortal™ system. This technology brought great benefits to sponsors as the first cardiac data web portal to provide real-time access to ECG waveforms from any Internet connection, eliminating the burden of client-side software installations.
2004
Cardiocore was the first core lab to deploy high-fidelity 12-Lead Holter recording capability in a Thorough QT trial. This technology records continuous cardiac data at 1,000 samples per second, enabling true one-millisecond resolution for accurate and consistent analysis.
2004
Cardiocore deployed its proprietary HolterGateway™ system. With currently active installations at many of the world’s leading clinical pharmacology units, this unique technology has flawlessly transferred terabytes of Holter data in scores of Thorough QT and other studies.
2005
Cardiocore opened its European headquarters outside London, UK. This location expanded Cardiocore’s support of its European and Asia-Pacific based clients, as well as investigative sites in all global regions.
2006
Cardiocore added Daniel Goodman, MD as a senior scientist providing cardiac safety consulting services. Like Cardiocore’s founder, Dr. Lawrence Satin, Dr. Goodman is a founding father of the cardiac core lab industry and an international thought leader. Previously, he directed medical affairs for Covance Cardiac Safety Services, and was recognized for his contributions to the advancement of cardiac safety testing in clinical trials.
2006
Cardiocore became certified by the Food and Drug Administration’s ECG Warehouse engineers for successful ECG data uploads to the regulatory database, and was recognized as an industry leader in the application of cardiac testing technologies. To date, all of Cardiocore’s Warehouse uploads have been free of delays or errors.
2007
Cardiocore opened its West Coast operation in South San Francisco, California, and expanded its service offering to include echocardiography (ECHO). Cardiocore staffed its San Francisco office with industry veterans with a proven track record of successful ECG, ECHO and Holter trials. This team included Polina Voloshko, MD and an experienced group of cardiovascular medical doctors who had collaborated for over 15 years as part of the esteemed Ischemia Research and Education Foundation.
2008
Cardiocore, in partnership with a Top Ten pharmaceutical client, became the first core lab to successfully format Holter ECG data for upload to the Telemetric and Holter ECG Warehouse (THEW). The THEW is a cardiac research initiative developed by the University of Rochester Medical Center in partnership with the Food and Drug Administration.
2008
Cardiocore completes first modern Holter Bin study for FDA and EMEA submission since the E14 Guidance was published. This advanced methodology for Thorough QT data analysis protects sponsors from potential false positive findings by eliminating the potentially misleading effect of heart rate hysteresis, and by overcoming the limitations of traditional QT correction techniques.
2009
Cardiocore completes second modern Holter Bin study. Traditional statistical analyses on this drug’s cardiac data would generate a positive outcome for QT prolongation, but Cardiocore’s Holter Bin method proved that the QT changes were related to non-dangerous heart rate variability rather than a potentially fatal ion channel blockade.
2010
Cardiocore opened its fourth global office, in Singapore, providing additional support for clinical trial sponsors and sites in the Asia-Pacific region.