Global CRO BioClinica has announced several initiatives in China and other Asia Pacific countries, following its March merger with CoreLab Partners, a provider of cardiac safety monitoring and imaging core lab services.
BioClinica has completed its first regulatory-mandated Thorough QT (TQT) cardiac safety study in China, a partnership with TEDA International Cardiovascular Hospital (TICH) in Tianjin, China and the expansion of local operational support for cardiac safety monitoring and imaging core lab services in Asia.
The TQT study, requested by the China Food and Drug Administration (CFDA), was conducted in collaboration with TICH in support of a new drug approval. BioClinica provided both in-country operational and scientific support for the study, including study design, project management, ECG data collection and extraction, ECG analysis and assistance with regulatory submission.
"The evolving regulatory environment in China will necessitate new safety standards and assessments of a similar nature for drugs in the pipeline, resulting in increased collaborative efforts and consultative input in support of Chinese pharmaceutical companies seeking domestic and global marketing approval for their new drugs," said Boaz Mendzelevski, M.D., BioClinica's vice president of cardiology.
"This study not only represents a remarkable success for BioClinica, but signals our continued investment of resources and expanding operational support in the emerging Asia Pacific markets," said Mark Weinstein, president and chief executive officer of BioClinica. BioClinica will support additional TQT studies in China later this year.