Our scientific experts with extensive experience from drug development have the aim to build maximum value in the first studies of your candidate drug.
We will suggest a tailor-made design of your early phase study, from Phase 0 to Phase IIa/b, based on a compilation of preclinical data and prediction of human PKPD properties, a thorough risk assessment and an in-depth consideration of the study objectives and endpoints. Read more here.
We may participate in scientific advice meetings with regulatory agencies and can guide you in the preparations for such meetings. Our advisory services further include, but are not limited to, sample size calculations, regulatory advice, clinical development plans, PKPD modelling and analysis, writing or review of scientific manuscripts and literature search and review.