The CPU provides consultations, evaluations, reports, and customized solutions.
It also provides consultation on regulatory submissions and offers scientific input for clinical protocols, clinical development plans, investigator brochures, and clinical pharmacology sections of Investigational New Drug (IND) and New Drug Applications (NDA).
The CPU assists investigators in optimizing phase I-IV study designs and dosing plans. Its recommendations accommodate the complexities of drug-to-drug interactions, the disease, and the health conditions of the trial participants.
It evaluates clinical trial data using advanced analysis techniques such as nonlinear mixed effect modeling, performs clinical trial simulations, and applies novel pharmacometric principles to clinical trial protocols.