Clinical Sample Analysis

Clinical Sample Analysis

      Our pharmacokinetic lab has been offering services to support bioanalytical needs for clinical development since 2015. High quality services and data integrity are ensured by our commitment to the highest levels of international regulatory compliance.




Service Highlights

  ■ Strictly compliant with regulations

  ■ Complete technology platform

  ■ Case-by-case service

  ■ In line with data tracking


  ■ Clinical pharmacokinetics

  ■ Bioequivalent

  ■ Immunogenicity

  ■ PK-PD study  

Regulatory Compliance

  ■ Compliant with CFDA, FDA and OECD GLPs

  ■ CFDA guide to clinical trial samples bioanalysis


  ■ Method development and validation (LC-MS/MS, ELISA, ECL, PCR)

  ■ Sample bioanalysis

  ■ PK parameter calculation and report writing

  ■ Data statistical analysis 


                    ■ Method development and validation (ECL, ELISA, SPR)

                    ■ Sample analysis (screening, confirmation, titration,  neutralization, subtyping)

                Data analysis and report writing


  ■ Method development and “Fit of Purpose” validation (LC-MS/MS, ELISA, ECL)

  ■ Sample analysis

  ■ PK-PD-related study and modeling

  ■ Report writing