We can assist pharmaceutical companies in the design of a drug development plan that expedites the successful transition to Phase II proof of concept.

By conducting Phase I Maximum Tolerated Dose (MTD) multiple rising dose studies in the target patient population, California Clinical Trials can facilitate surrogate marker evaluation and pilot demonstration of efficacy and safety. We can routinely assess cardiac safety early in compound development for Sponsors, such as QTc changes, as well as assess pharmacogenetic/drug interaction issues and neuroendocrine changes.

Early determination of 'proof of principle' and the performance of studies that provide comparative surrogate marker data in healthy normals and patients, as well as between placebo, active control, and novel compound, best inform decisions regarding drug development.

Most importantly, CCT provides quality information that allows pharmaceutical companies to confidently make early and accurate decisions whether to terminate compound development prior to expensive multi-center Phase II trials in target populations such as Alzheimer's, Depression, Schizophrenia, and Migraine patients.

Learn more about our Early Drug Development services.