SEND is an implementation of CDISC’s (Clinical Data Interchange Standards Consortium) SDTM (Study Data Tabulation Model) for nonclinical studies. SEND specifies a standard format for presenting nonclinical study data in a consistent, structured format to enable electronic data review.
Nonclinical data included in regulatory submissions to FDA CDER (Center for Drug Evaluation and Research) must now be in SEND format for all studies and datatypes modeled in SEND.
Certara accelerates medicines to patients using proprietary biosimulation software and technology to transform traditional drug discovery and development. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries.
Please visit us at https://www.certara.com/