Asian Bridging Studies
During early clinical development, there is an increased interest by Sponsors in conducting “ethnobridging” studies to support the overall clinical development plan strategy and to accelerate product introduction in the Asian markets. Ethnobridging studies conducted during early phase clinical development often focus primarily on the pharmacokinetic equivalence between Asian and non-Asian populations. In addition, regulatory agencies may also want additional data such as cardiac ECGs and adverse event (AE) collections to evaluate potential safety differences between the two populations.
With a dedicated Asian Bridging Studies Unit at its Long Beach, CA location and multilingual recruitment and clinical operations staff, Collaborative Neuroscience Research (CNS) helps pharmaceutical companies efficiently reach patients in Asian markets by conducting trials in Japanese, Chinese, and Korean populations that generate data acceptable to native country regulators.
CNS conducts dual population (i.e., both Asian and non-Asian volunteers) trials in early development as well as separate studies in only Asian volunteers in later development. We offer thought leader expertise in protocol design and detailed knowledge of regulatory issues – expert advice and information to accelerate timelines, reduce costs, and maximize the value of your compound being studied.