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.
Expertise and Capabilities
- Apex team has been the designer/investigator on 100+ Asian studies
- Decades of experience in ethnically sensitive clinical trial testing
- Extensive experience helping Sponsors with regulatory interactions with the Pharmaceuticals and Medical Devices Agency (PMDA)
- Significant expertise in collection of additional safety (e.g., ECG) and pharmacodynamic (e.g., cognitive testing) data in Asian populations
- Dr. Larry Ereshefsky, Chief Scientific Officer at Apex, was the Contributing Author: Accelerating Global Drug Development: The Science and Practice of Ethnobridging, now in a second edition
Asian Bridging Studies Unit
The purpose-built 16-bed Asian Bridging Studies Unit was designed to make volunteers as comfortable as possible during their stay. Separate from the rest of the Long Beach inpatient facilities, it has its own lounge and dining areas as well as a kitchen with specialized equipment for the preparation of typical and/or study-specific Asian meals (if the protocol allows, CNS also regularly provides catering from local Asian restaurants). The unit offers a variety of amenities to meet volunteers’ entertainment needs. All staff on the clinical research unit have regularly scheduled cultural sensitivity training to understand each ethnic group’s expectations, enhancing the participant experience.
- Located in the metropolitan region with the world’s largest first-generation Asian community
- Experienced recruitment team comprised of 20+ full-time professionals including recruiters fluent in Asian languages
- Extensive database with 3,000+ Asian subjects
- Referral relationships with Asian community groups, language schools, and physicians
- Outreach specialists participating in Asian community and cultural events
- History of successful advertising in Asian language publications and on social media
- We receive many word-of-mouth referrals and repeat volunteers by exhibiting cultural competence.