Case Study

PK Bioanalysis

  • Large multinational pharmaceutical company PK study
  • One LC/MS/MS method to detect two endogenous hormones
  • LLOQ at 5pg/ml and 10pg/ml, respectively
  • MicroConstants China and USA team worked closely for method development
  • Feasibility study finished in two weeks
  • Identified matrix without endogenous hormones
  • Completed the method development/validation/sample bioanalysis in timely manner
  • Passed CFDI on-site inspection
  • Products are approved in China

BE Clinical Studies

  • A biotech company based in U.S.A. and Beijing/Shanghai
  • First NDA to be submitted to NMPA in July, 2017
  • Need to conduct a BE study to compare drugs in Phase II/Phase III clinical studi
  • Clinical Trial Approval (CTA) for BE studies wasn’t received until Dec. 2016
  • MicroConstants China secured the BE slots at No. 307 Hospital ahead of time
  • Submitted IEC/MOST documents before Chinese New Year.
  • Subject recruitment soon after Chinese New Year
  • Subject recruitment soon after Chinese New Year
  • Expedited bioanalysis without additional charge
  • Received CSR (chopped) within 6 months
  • Passed CFDI on-site inspection
  • Product was approved in China (First in the world)
  • Received Best CRO Award from the client

TQT Study

  • A biotech company based in U.S.A. and Shanghai
  • First NDA to be submitted to NMPA in 2019
  • Both FDA and NMPA asked for TQT study for its antibiotic drug
  • Huashan Hospital is chosen to carry out the TQT study
  • Bilingual clinical protocol/CSR for both FDA and NMPA registration
  • Conducted site qualification to ensure ICH GCP compliance
  • On-site trainings for TQT/Holter/project management to ensure smooth execution
  • 52 subjects, 4 periods, 4 way crossover design with Moxifloxacin as positive con
  • 203/208 perfect continuous ECG collection
  • Best ECG collection over 200+ TQT studies conducted by ERT
  • Data to be submitted to China NMPA in year 2019

GCP Implementation

  • Collaboration with Phase I Unit of No. 307 Hospital of PLA in 2009
  • Quality system review to identify/fix major deficiency
  • ICH GCP mindset training/SOP development and implementation
  • Established QA department and conducted QA training
  • SIDCER/FERCAP accreditation for the IEC
  • CNAS accreditation for PK laboratory
  • Conducted BE study for a top 30 pharma together in 2010
  • Conducted PK study for a top 10 pharma together in 2011
  • Became qualified Phase I Unit by Quntile
  • Working together for QA to ensue ICH GCP compliance.