Overview The client is a global BioPharma company focused on its mission to discover, develop and deliver innovative medicines to patients with serious diseases. The organization has been involved in the CDISC SEND (Standard for Exchange of Nonclinical Data) committee since the early 2000’s, when the first wave of discussions began. The client is an active contributor to the CDISC SEND consortium, working alongside other pharma organizations, CROs, vendors and the United States Food & Drug Administration (FDA). Originally driven by the FDA’s Critical Path Initiative to bring medical breakthroughs more quickly to market, SEND supports electronic submission of study data to the FDA, enabling more efficient, higher quality regulatory reviews. In December 2014, the FDA issued Fin

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