Auris will use the Medidata’s Clinical Cloud for randomization and trial supply management (RTSM); electronic data capture (EDC) and clinical data management (CDM) in the forthcoming Phase III program with AM-101.
Auris Medical founder and managing director Thomas Meyer said, "As we conduct clinical trials in this new field of study, we require a solution that will be hassle-free for our sites but also provide rapid implementation, robust data management and study agility."
The Medidata Clinical Cloud solution includes embedded eLearning, allowing the clinicians to learn the system and initiate trials.
With Medidata’s infrastructure, Auris can easily integrate the Medidata Cloud with patient reporting and lab data systems, reducing the need for manual data integration and significantly shortening study start-up times and data management cycles.
Medidata Solutions president Glen de Vries said, "We’re thrilled to work with Auris to help them tap into the power of our cloud-based platform to support the development of pioneering cochlear therapies."