The Standard for Exchange of Nonclinical Data (SEND) is the non-clinical implementation of the Study Data Tabulation Model (SDTM) developed and maintained by the Clinical Data Interchange Standards Consortium (CDISC). SEND provides a framework for standardized electronic representation of individual study data endpoints, which enable the efficient exchange of data between organizations. Standardized SEND data makes it possible to design tools for data visualization, data analysis and data warehousing. It allows single-study and cross-study analytics. SEND increases the quality and efficiency of scientific review for regulatory submissions.

　As a full-service Contract Research Organization (CRO), Charles River Laboratories (CRL) has been involved in the development and implementation of the SEND standard since 2001 and continues to be an industry leader, with team members taking active leadership and volunteer roles in both the CDISC and Pharmaceutical Users Software Exchange (PHUSE) organizations.

　The story of the Standard for Exchange of Nonclinical Data (SEND) began in the late 20^th century, when industry guidances about electronic regulatory submissions were issued by the United States Food and Drug Administration (US FDA) and the International Conference on Harmonisation [(ICH), now recognized as the International Council for Harmonisation]. These documents and subsequent supporting guides contain details and specifications for electronic submissions, including settings for portable document format (PDF) documents and SAS Transport Files and the order for arranging the submission content ^1,2). In the early 2000s, electronic data capture systems were rudimentary when compared with the capabilities of today's software, and many data types were recorded on paper. The effort involved in preparing just the tumor.xpt, the pioneer for the SEND concept, was enormous ³⁾. The tools available at the time were not sophisticated enough to trace a palpable mass and its measurements noted during inlife to the observations recorded at necropsy and finally to correlate with the pathologist's findings and diagnoses. Now, over 20 years later, and with the introduction of multiple new guidances and guides, rule sets, official versions, and effective dates, the idea of data presented in a standardized format has moved from reluctant adoption to acceptance and even to expanded use beyond a regulatory submission.