Bioclinica Predicts Demand for TQT Trials in China

Bioclinica has partnered with a Chinese hospital citing growing regulatory pressure for cardiac safety studies in the country as the key driver.

The US firm announced the ‘strategic partnership’ with TEDA International Cardiovascular Hospital (TICH) in Tianjin this week, claiming that the two organisations have already completed the first regulator-mandated Thorough QT (TQT) study in China.

The study - which was conducted in order to support an unnamed local drugmaker’s approval efforts - is likely to be the first of many in China according to 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"

This was echoed by company director of operations in Asia, Onglee Weng, who said: “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."

The new partnership follows just six months after Bioclinica was acquired by private equity firm JLL for $123m (€91m) and appears to be in keeping with CEO Mark Weinstein’s prediction that the takeover would help the contract services firm build “global scale.”

CoreLab the firm that JLL bought and merged with Bioclinica in January, conducted the first regulatory-mandated TQT trial in Japan in 2010 in collaboration with Japanese partner Suzuken.