– Global Company Expands Operational Capabilities to Support Growing Clinical Trials in Asia Pacific –
BioClinica®, Inc., a global provider of clinical trial management services, has recently announced several major initiatives to better serve its growing sponsor client base in China and other Asia Pacific countries, following its March 2013 merger with CoreLab Partners, a leading provider of cardiac safety monitoring and imaging core lab services. The achievements include the completion of the first regulatory-mandated Thorough QT (TQT) cardiac safety study in China, a strategic 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.
First TQT Study in China
This landmark cardiac safety study, requested by the China Food and Drug Administration (CFDA), was conducted in collaboration with the TEDA International Cardiovascular Hospital (TICH) in support of a new drug approval for a domestic sponsor. 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. This TQT study builds on BioClinica's cardiac safety leadership in the region, having successfully completed the first regulatory-mandated TQT study in Japan in 2010.
"Cardiac safety is gaining momentum in China and I am pleased to have been part of this collaborative TQT study in support of the changing regulatory landscape surrounding cardiac safety" said Boaz Mendzelevski, MD, BioClinica's Vice President of Cardiology. "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". Details of this unique TQT study were presented at the recent annual DIA China meeting in Beijing by Dr. Jennifer (Jie) Hou, head of the TICH Phase 1 Clinical Trial Unit, and Dr. Mendzelevski.
"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" added Mark Weinstein, President and CEO of BioClinica. On the heels of this study, BioClinica will be supporting additional TQT studies in China later this year.
Partnership with TICH
Following the success of the first TQT study in China, BioClinica has announced a strategic partnership with the TEDA International Cardiovascular Hospital. Under this partnership, BioClinica will provide integrated clinical and centralized cardiac safety services at TICH for domestic and foreign sponsors seeking drug approvals in China. "There is a substantial need for cardiac safety services in certified clinical facilities, and this partnership will make it easier for Pharmaceutical sponsors to meet changing regulatory standards in the region" said Dr. Onglee (Li) Weng, Director of Operations in Asia, BioClinica. "We are thrilled to be able to support new regulatory initiatives in China and are poised to make a large impact on the development of safer pharmaceuticals in the Asia Pacific Region" added President and CEO Mark Weinstein.
Expanded Service, Scope and Clinical Trial Support in Asia Pacific Region
As part of BioClinica's commitment to supporting clinical drug development in Asia Pacific, BioClinica has developed strategic partnerships with local medical technology providers, made key infrastructure investments, and established local scientific and medical expertise so as to provide a comprehensive suite of cardiac safety solutions and imaging core lab services for clinical trial sponsors. Under the leadership of Dr. Onglee (Li) Weng, Director of Operations in Asia, BioClinica has added significant personnel to its workforce in China and Japan to fulfill key roles including DICOM conversion, medical image quality assurance, medical image management support, project management, and business development. By providing in-country support for clinical trials in Japan and China, BioClinica is able to offer high-quality services, local regulatory expertise and fast turnaround times for Asian-based clinical trials.
BioClinica representatives will be available to discuss Cardiac Safety Solutions at the Drug Information Association annual meeting June 24th through 26th in Boston, Massachusetts in Booth 1210. Jeffrey Heilbraun, MS, BioClinica's Director of Strategic Development, will present on the topic "Off-target Blood Pressure Changes and Evaluation in Drug Development: Safety, Clinical and Regulatory Considerations" on June 27th at 10:45AM as part of the Clinical Safety and Pharmacovigilance track.
About TEDA International CV Hospital (TICH)
TEDA International Cardiovascular Hospital is a public, non-profit, three A-level hospital with granted Joint Commission International Accreditation. TICH has met international standards in terms of patient safety and service quality. The hospital has a state of the art phase I clinical trial center and a well-equipped central laboratory. TICH has clinical trial certification from the Chinese Food & Drug administration and a ISO15189 laboratory accreditation certificate by the China National Accreditation Service for conformity assessment. There have been national and international clinical trials at TICH.