SEND
3．SEND Implementation and Challenges
2021 年 2021 巻 23 号 p. 13-17
詳細
2021 年 2021 巻 23 号 p. 13-17
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.
