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