title: Responses to the Standard for Exchange of Nonclinical Data (SEND) in non-US countries.
abstract: The Standard for the Exchange of Nonclinical Data (SEND), adopted by the US FDA, is part of a set of regulations and guidances requiring the submission of standardized electronic study data for nonclinical and clinical data submissions. SEND is the nonclinical implementation of SDTM (Study Data Tabulation Model), the standard electronic format for clinical regulatory submissions to FDA. SEND, SDTM, and the associated Controlled Terminology have been developed by CDISC (Clinical Data Interchange Standards Consortium). In order to successfully implement SEND, interdisciplinary contributions between sponsors and CROs, need a model for task allocation. This is being undertaken by the Pharmaceutical Users Software Exchange (PhUSE). Because SEND is currently the preferred submission format of the US FDA only and will become required by it starting in December 2016, only American academic societies and companies are actively involved. An exception to this is the INHAND initiative, which leads the way in standardizing terminology for toxicological pathology. On the other hand, international globalization of other clinical and nonclinical practices is not feasible because there are substantial differences between the US and non-US countries in CRO involvement in drug development. Thus, non-US countries must consider and develop approaches to SEND that meet their needs. This paper summarizes the activities of the major organizations involved in SEND development and implementation, discusses the effective use of SEND, and details a compliance scheme (research material of the Showa University School of Medicine) illustrating how pharmaceutical companies can complete a large amount of work up to an FDA application with the effective utilization of CROs and solution providers.
authors.affiliation: Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa, Tokyo 142-0064, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Anzai
authors.affiliation: Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa, Tokyo 142-0064, Japan.
authors.forename: Masamichi
authors.initials: M
authors.lastname: Kaminishi
authors.affiliation: Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa, Tokyo 142-0064, Japan.
authors.forename: Keizo
authors.initials: K
authors.lastname: Sato
authors.affiliation: PDS Life Sciences, 100 Valley Road, Suite 204, Mt. Arlington, NJ 07856, U.S.A.
authors.forename: Laura
authors.initials: L
authors.lastname: Kaufman
authors.affiliation: LunaPath LLC, Aoihigashi 3-5-1, Naka-ku, Hamamatsu-shi, Shizuoka 433-8114, Japan.
authors.forename: Hijiri
authors.initials: H
authors.lastname: Iwata
authors.affiliation: Department of Nutritional Science and Food Safety, Faculty of Applied Biosciences, Tokyo University of Agriculture, 1-1-1 Sakura-ga-Oka, Setagaya, Tokyo 156-8502, Japan.
authors.forename: Dai
authors.initials: D
authors.lastname: Nakae
keywords: CDISC; FDA; INHAND; SEND; controlled terminology