Clinical Affairs
At Amarant, we help identify any issues or roadblocks and make corrections with the aim of expediting the path to approval, understanding how regulatory strategy and operational procedures interact. Working collaboratively across cross-functional disciplines, we engage biostatistics, medical experts, and operational leaders to create a robust design for each stage of development.
Services We Offer
- Due diligence
- Bioavailability & Bioequivalence studies
- Gap analysis, critical risk identification, and contingency planning
- Selection of CROs
- Protocol design
- Study Monitoring and CRO Audits
- In-Vitro & In-Vivo correlation (IVIVC) Studies
- Sample size estimation and justification
- PK modelling & analysis
- Randomization & Statistical analysis using SAS
- Report preparation in E3 and eCTD formats
- Safety strategies and risk management
- Regulatory development strategy & submissions
- BE Designs, Biowaiver Documents
- Scientific Advice