CRO MicroConstants China, which conducts preclinical pharmacokinetic studies, early-stage clinical trials and regulated bioanalysis in China, has signed a strategic collaboration agreement with the clinical research center of the No. 307 Hospital of People's Liberation Army to provide site management services.
The agreement designates MicroConstants China as No. 307 Hospital's official site management organization (SMO). Over the past three years, MicroConstants China has worked closely with the phase I unit of No. 307 Hospital to implement quality systems and procedures that comply with ICH GCP guidelines, including developing SOPs, training clinical site personnel, performing QA audits and installing a clinical trial information management system.
"Through our collaboration with MicroConstants China, we have learned the true meaning of GCP compliance in daily practice and are now capable of identifying deficiencies and coming up with corrective actions to address them," said Dr. Zeyuan Liu, director of the clinical pharmacology unit at No. 307 Hospital. "Working with MicroConstants China enabled us to improve our quality system in a short period of time and effectively win contracts from major global pharmaceutical companies."
Dr. Q. David Yang , CEO of MicroConstants China, said, "Our goal is to implement ICH GCP compliant quality systems for more clinical trial centers in China so their clinical trial data can be submitted directly to the FDA and the EMA for approval.”
Established in 1957, the No. 307 Hospital of People's Liberation Army is among the top tier hospitals in China with 38 specialty groups and over 1,100 beds. Its clinical trial center is certified by the SFDA for phase I clinical studies and phase II/III/IV clinical studies for cancer, hematology, anti-radiation, detoxification and anti-dependency drugs. MicroConstants China was established in 2007 by MicroConstants, a bioanalytical and DMPK specialty CRO in San Diego, Calif.