Medical and Clinical Development

Drug trials and approval processes seek to verify that a new drug candidate is safe for human patients and effective in treating the target disease.

The Medical and Clinical Development department is responsible for the design and execution of Phase 2 and Phase 3 clinical trials. In Phase 2 the investigational drug is given to a small number of people who have a particular disease or condition in order to determine dosage and delivery method effectiveness. Safety is also simultaneously evaluated at this time.

The extensive data resulting from Phase 2 and Phase 3 clinical trials provide a basis for predetermining the results patients in the general population will experience when the investigational drug is approved. The data will also be utilised to determine the labeling information that will be provided with the product.