CRS experts provide integrated services to support biopharmaceutical and medical device companies. We collaborate with regulatory experts to develop innovative and customised strategic programmes for clients focusing on regulatory milestones and clinical development planning and execution. CRS experts provide distinguished advice and integrated services to support biopharmaceutical and medical device companies in their early phase product development. In this respect we develop innovative and customised strategic programmes for our clients, focusing on regulatory milestones and clinical development planning and execution.
Our experts are particular experienced in all matters of first-in human and early phase clinical trials
CRS has more than 40 years experience in early phase clinical trials with new pharmacological entities and medical devices. Our experts support clients in the conceptual design and setting up of all kind of trials in early clinical development, covering first-in-human (FiH), single ascending dose (SAD), multiple ascending dose (MAD), bioavailability (BA), drug-drug interaction, cardiac safety, and vaccination studies.
Moreover, we support clients with our distinct knowledge for handling numerous secondary pharmacodynamic endpoints in different therapeutic indications. Our regulatory experts offer extensive experience with the requirements of the European Medicines Agency (EMA) and national European regulators as well as the U.S. Food & Drug Administration (FDA).
CRS provides comprehensive guidance in all matters concerning strategic product development, regulatory liaison activities (e.g., submissions, scientific advice meetings), and preclinical and clinical research programmes.
