China has become a global market in many aspects. The region has great potential for the biopharmaceutical and medical device businesses. Many global organizations have established or are planning to establish clinical trial/data centers in China. With this emerging market, it is now even more essential to partner with a CRO to support your clinical development needs.
Brightech has a distinguished reputation in this market. We have close relationships with hospitals, Key Opinion Leaders (KOLs) and the Chinese State Food and Drug Administration (CFDA). Several of our consultants serve as Subject Matter Experts (SME) to the CFDA. Brightech’s team has extensive experience conducting full-service clinical development services in China. We understand the culture and are familiar with regulations of the CFDA. If you want to explore the market potential for entering China or to conduct a clinical trial there, Brightech can provide a comprehensive suite of services.
• Feasibility analysis
• Strategic planning
• Regulatory affairs consulting
• Over-the-Counter (OTC) market approach
• Clinical Trial Authorization (CTA)
• Document translation
• Communication with CFDA
• Identify and select trial hospitals (or investigative sites)
• Conduct and manage clinical trials in China (full-service)