Planning Nonclinical Studies

Based on the type of product and the selected indication, B4D will work with toxicology experts with the required experience to develop a nonclinical program of studies to support the FIH clinical trial. Where possible, study elements will be combined to maximize the information obtained from a single study. B4D will identify qualified CROs to conduct these studies under GLP and can organize audits of the selected facilities. B4D will also map out the nonclinical requirements at each stage of clinical development to ensure you are prepared for each step in your regulatory filing without incurring large financial commitments in the early stages of clinical development.