Clinical Trial Services
MicroConstants China has established partnerships with a number of CFDA certified clinical trial centers in China through GCP quality system consultation and providing proprietary Clinical Trial Management System (CTMS) and EDC solutions. MicroConstants China actively manages the Phase I clinical pharmacology unit of the Affiliated Hospital of Academy of Military Medical Sciences (No. 307 Hospital of PLA) after several years of implementing ICH GCP quality system in there together. The Unit specializes in conducting Phase I safety studies, PK studies, bioequivalence, bioavailability and drug-drug interaction studies in China with healthy volunteers or special patient populations. Prior to the start of any clinical study at our partnering clinical facilities, MicroConstants China will perform a thorough site qualification and conduct GCP training to ensure all clinical studies conducted will meet GCP regulations. And the PK/BE study samples are analyzed at MicroConstants China with OECD GLP compliant bioanalytical laboratory in Beijing. MicroConstants China partners with Instem of UK, a leading supplier of IT applications to the early development healthcare market delivering compelling solutions for data collection, management and analysis across the R&D continuum, to deliver CTMS/EDC solutions for clinical trial centers. MicroConstants China uses New York based Target Health's eCRO solutions for clinical trial management, including Target e*CRF®, Target eCTR®, Target Document®, Target Encoder®, Target e*Pharmacovigilance®, and Target e*CTMS®, which have been used for over 300 clinical trials and been successfully accepted by USFDA and other regulatory agencies. MicroConstants China also provides cardiac safety study and eCOA in-country support in Greater China region for eResearch Technology (ERT), a global leader in providing high quality patient safety and efficacy endpoint data collection solutions for clinical drug development. ERT has forty years of experience in collecting and analyzing cardiac safety data through 6,000+ clinical trials (1,000-plus ongoing) in over 95 countries, more than 200 TQTs, and tens of thousands of investigation sites across the globe at any time. Beyond sheer statistics, ERT's expertise is rooted in its services: ECG recording, transmitting, processing and reporting as well as its commitment to metrics.ERT has combined scientific and regulatory expertise with innovative technology to deliver reliable COA consulting services and practical electronic solutions that ensure the patient voice is heard during new medical product development. Capturing Clinical Outcome Assessment (COA) data (including PROs, ClinROs & ObsROs) electronically avoids errors associated with manual data entry and inaccurate, incomplete or illegible data.
The case study below provides specific example of ways we have helped advance our clients' drug development program in China. A MNC was conducting PK studies in Chinese population for one of their imported drugs. The bioanalytical challenge is they need to detect two endogenous compounds in the serum with LLOQ of 5 pg/mL and 10 pg/mL, respectively in single assay. MicroConstants China offered free feasibility study and within 2 weeks, our method developer, working together with MicroConstants San Diego method development team, came up with a derivatization method that can meet the client's requirement with pure compounds. Then our team developed a method to deplete these two endogenous compounds so that we can have a matrix that can be used for making standards and QC samples. The method was fully validated according to CFDA and EMA guidelines on bioanalytical method validation and successfully used to measure the concentrations of these two endogenous compounds.Since 1998, MicroConstants San Diego has developed over 1,600 LC/MS/MS, HPLC/UV, HPLC/FL, and ELISA methods, including more than 100 non-proprietary assay methods. Our Beijing team work side by side with San Diego team for novel bioanalytical method development for our clients in China. 已验证的生物分析方法列表