As a leading Site Management Organization （SMO） in China, MicroConstants China co-manages a Phase I Unit in Beijing and is implementing ICH GCP quality system in a number of clinical trial centers in China. These clinical trial centers are all CFDA GCP certified and specialized in conducting first in human, PK and BE studies as well as late phase clinical trials for product registration in China and abroad. MicroConstants China’s staff is actively involved in project management, quality assurance and clinical trial coordination at our SMO partnering clinical sites.
MicroConstants China's in-house bioanalytical laboratory in Beijing, China has been endorsed for OECD GLP compliance and received accreditation from CNAS (ISO17025). Its bioanalytical laboratory specializes in method development, method validation, and PK sample analysis for small molecules, proteins, and peptides using LC/MS/MS, HPLC/UV, and ELISA according to applicable regulations and guidelines of China CFDA, USFDA, EMA and other regulatory agencies.
MicroConstants China also provides GLP/GCP quality system consultation/QA audit, technology transfer, and drug development consultation/project management services to our clients.