Central laboratory testing is ideal for pharmaceutical trials, especially multi-center studies, as most on-site laboratories lack the means to perform sensitive, validated, and regulations-compliant testing regarding drug safety and efficacy. In addition, protocol, reference range, and analysis differences among local labs may result in unacceptable levels of bias and variation in the trial data, obstructing meaningful interpretation.
As an experienced industry leader, KingMylab has established an internationally recognized clinical trial testing and management system, including CAP, ISO15189, GCP and GLP compliance under the 21CFR Part 11 regulation, to ensure the authenticity, integrity and accuracy of experimental data. With more than 82 technical platforms, 4,000+ validated tests, and more in development, KingMylab offers one-stop central laboratory and bioassay solutions to satisfy all your clinical trial testing needs from Phase I to Phase IV.
The Mass Spectrometry Center is the first clinical mass spectrometry laboratory of "CAP and ISO15189 dual systems in parallel" in China. The Center has nearly 300 independent research and development projects, which can provide mass spectrometry testing services including genetic metabolic disease detection, endocrine disease detection, nutrient monitoring, therapeutic drug concentration monitoring, and drug analysis.
The Mass Spectrometry Testing Center brings together a group of professional and technical personnel with analytical chemistry and clinical professional background. The discipline leader has overseas training experience, more than 10 years of experience in physical and chemical analysis and testing, rich experience in clinical mass spectrometry project research and development and laboratory management. Furthermore, many well-known experts and scientists at home and abroad have been invited to serve as technical consultants to lead the development of technology in the direction of internationalization, standardization and high-end.
The center has all kinds of international sophisticated mass spectrometry testing equipment, and has built a complete mass spectrometry testing platform.