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 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
  • Analysis of biological samples that have been validated or verified, that 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.