A critical step on the road to regulatory approval and market launch, Clinical Development begins after the Discovery Phase and proof of concept.
To navigate this phase successfully, you need a multidisciplinary strategic plan that establishes the objectives of your clinical program. It should also align with your requirements and non-clinical/pre-clinical data whilst at the same time ensuring you meet regional regulatory requirements that align with commercial plans.
Your clinical program should be appropriately powered to allow you draw valid conclusions, but a balance with study size is required to ensure the development costs are controlled. It is also important to take real world evidence and market access into consideration as you work out clinical protocols and synopsis design.
During the course of a drug’s clinical development, continuous review of the incoming trial data is also a key factor in avoiding delays and reducing costs.