To enhance the quality of clinical research services, the GoBroad Healthcare Group's Clinical Research Center has established the "GoBroad Cardiac Safety Evaluation Center." This center integrates clinical experts in cardiology from its affiliated hospitals. Adhering to the preclinical guidance principles ICH S7B and clinical guidance principles ICH E14, the center has developed an electrocardiogram (ECG) central reading and transmission system that meets data safety and quality requirements. It has successfully conducted several TQT trials and early-phase clinical C-QT analysis experiments.

The GoBroad Cardiac Safety Evaluation Center has a team of medical professionals and a highly efficient project management team trained in cardiovascular and electrophysiology. They systematically compare early clinical trial dimensions, including cost, efficiency, and accuracy, and provide ECG laboratory services through an independent panel of experts to further assess the risk of Torsades de Pointes (TdP). Additionally, the center offers experienced quantitative pharmacology services, including trial design, research and development strategies, and PK/PD model analysis.

TQT and C-QT trials help identify the drug’s impact to the heart at different exposure levels during the early stage of drug development. Coupled with comprehensive evaluation methods, these trials detect cardiac risk in specific populations, and reduce costs in new drug development. The goal is to establish a cardiac safety evaluation system suitable for the research landscape in China.

Dr. Hou Jie, the Chief Medical Officer of the center, completed the first TQT trial in China , which is compliant to ICH E14 requirement in 2013. Dr Hou also has experiences of over 20 first-in-human or dose escalation C-QT analysis trials.