equilab babe unit activities

BA / BE Activities

We provide end-to-end services for the BA/BE study

Pre-study engagement
  • Bioavailability/bioequivalence study protocol development
  • Protocol submission for regulatory approvals and ethical clearance
  • Analytical method development and validation of drugs in biological specimens
  • Comparative dissolution testing and result discussion
  • Counseling visit and study briefing to minimize the risk in BA/BE study
Study project management
  • Clinical project planning and management
  • Subject screening, recruitment and management
Clinical and analysis
  • Study implementation and monitoring
  • Collection and storage of biological specimens
  • Board range of bio-analytical techniques and methods comply to International standards
Reporting and quality
  • Data management and statistical analysis
  • Final report write-up.
  • Documentation & adverse events reports
  • Proven quality assurance
Customer focus
  • Intensive discussion and counseling before, during, and after BA/BE Study about the BA/BE related issues
  • Facilitating the publication of BA/BE result in the scientific journal publication and magazine
  • Socializing the BA/BE knowledge to the sponsor’s team and stakeholder e.g. marketing team, medical representative, physician, etc
  • Customer support for registration problem handling or provide additional data for export purposes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Our integrated BA/BE study activities are described in the flow chart below.