Clinical Trial Material
During the clinical stage of development, API requirements for quality and scale are rapidly evolving. All the while, new risks are introduced, and processes are scaled up to meet the needs for clinical trials. As process knowledge rapidly evolves through Process Development and first-hand experience, so does the understanding of risk and practical versus theoretical. Managing risk while maintaining timelines requires careful planning, execution, monitoring and excellent communication. Project by highly experienced, interdisciplinary teams to ensure all aspects of synthesis, engineering and analytical are considered and controlled using phase-appropriate approaches.