BEIJING, Jan. 28, 2013 -- MicroConstants China Inc., a Contract Research Organization (CRO) conducting 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 International Conference on Harmonization Good Clinical Practice (ICH GCP) guidelines. This has included developing standard operating procedures (SOP), training clinical site personnel, performing quality assurance (QA) audits, installing a clinical trial information management system (CTIMS), and obtaining SIDCER Recognition from the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP).
"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."
"The execution of this strategic collaboration agreement verifies our achievements and is an important step for our SMO business," said Dr. Q. David Yang , chief executive officer of MicroConstants China. "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 United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval."
About the No. 307 Hospital Clinical Research Center
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. Their 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. The clinical research center has conducted clinical trials for more than 200 sponsors, including eight of the top ten global pharmaceutical companies.
About MicroConstants China Inc.
MicroConstants China Inc. is a Contract Research Organization (CRO) that was established in 2007 by the founder and president of MicroConstants, Inc., a bioanalytical and DMPK specialty CRO in San Diego, California with over a decade of GLP compliance history. Located in Beijing, MicroConstants China conducts preclinical and clinical pharmacokinetic studies, provides regulated bioanalysis and analytical services, and offers early-stage clinical trial management services and quality system consulting. For more information, please visit http://www.microconstants.com.cn.