We provide one-stop services for BE/BA study covering protocol development, ethics submission, clinical studies, bioanalysis, pharmacokinetic and statistical analysis, and the final study report.  Our clinical team has broad knowledge and experience in conducting a variety of BE study designs, including two-way cross-over, parallel, single/multiple dose, fasting and fed studies. 

Our provided services

• Study management

• Pilot and pivotal bioequivalence

• Study design and protocol development

• Ethics committee approval 

• Patient recruitment and informed consent form (ICF)

• Case Report Form (CRF) design

• Clinical study and clinical monitoring

• Analytical method development and validation

• Bioanalysis

• Data management 

• Biostatistics (using validated SPSS® and WinNonlin ® software)

• Report preparation (bioequivalence report, clinical report, analytical report, and statistical report)