iCardiac Technologies, a market and innovation leader in cardiac safety and respiratory studies, and SNBL CPC Japan, an experienced and reputable Site Management Organization (SMO) in Japan, have announced that they will collaborate on cardiac safety studies in Japan.
The collaboration will involve both Thorough QT (TQT) studies as well as QT assessment in phase I studies. It will also enable CPC Clinical Trial Hospital of Medipolis Medical Research Institute, a highly experienced phase I site, which SNBL CPC Japan has been supporting, to offer iCardiac’s advanced High Precision QT and Early Precision QT analysis methodologies to its sponsors. The companies will partner to further educate the Japanese pharmaceutical market on scientific and regulatory changes enabling QT assessment as part of phase I studies.
The agreement stems from recent developments involving iCardiac’s central role in conducting a validation study demonstrating the reliability of using QT data obtained from phase I studies. This approach of using phase I data for regulatory decision-making, which enables an alternative path to conducting a TQT study, was approved in December 2015 by the International Council for Harmonisation. Since then, Japanese regulators have approved a TQT waiver for an iCardiac customer.
“We are honored to be working with SNBL group, a preeminent provider of clinical trials services. iCardiac has been at the forefront of developing, validating, and popularizing the use of early QT data as an alternative to doing a TQT study, and we are extremely pleased to have a partner to offer these advanced services in the Japanese market,” said Alex Zapesochny, president & CEO of iCardiac Technologies.
Hisao Nakajima, president of SNBL CPC Japan, echoed, “We are also honored to introduce into Japan the advanced QT assessments developed by iCardiac. SNBL group is very pleased to serve our clients, pharmaceutical companies, for efficient drug development through the new cardiac safety technologies stemming from this collaboration.”
