Drug Development
Design and Analysis of Studies
We design efficient and informative drug development studies and analyze them using pharmacometrically-guided approaches that enable us to extract hidden knowledge and make the most of study data. The studies are designed to enable the ease of dose selection and dosage optimization. Such studies include proof of concept and efficacy and safety studies. We develop models to provide a clear understanding of drug efficacy and safety.
Strategy Consulting
Drug development is a complex process that requires knowledge of the science and the process, interaction with regulatory agencies, and an understanding of drug evaluation and regulation. With a combined 50 years of experience we offer strategic solutions that result in breakthrough drug development. This service ranges from the review of currently available information on a program to the provision of expert advice on studies needed for a development program and drug development strategy. |