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
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| Study project management |
- Clinical project planning and management
- Subject screening, recruitment and management
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| 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
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| Reporting and quality |
- Data management and statistical analysis
- Final report write-up
- Documentation & adverse events reports
- Proven quality assurance
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| 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
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