Standard for Exchange of Nonclinical Data (SEND)
What is SEND?
SEND is the Standard for Exchange of Nonclinical Data between organizations, including sponsors and their outsourcing partners, for submission to the U.S. Food and Drug Administration (FDA) and other regulatory bodies. It provides a standard format for the submission of nonclinical data to regulators. It is important to note that SEND does not impact data collection processes – only the submission of the data.
Why was SEND created?
SEND was created by the Clinical Data Interchange Standards Consortium (CDISC) in 2002 to execute on the Study Data Tabulation Model (SDTM) for the submission of nonclinical studies. The standardization of data presentation significantly reduces the time that regulators spend sifting through reports to identify pertinent data, which accelerates the progress of developmental drugs, thereby reducing costs to developers. Following CDISC’s successful launch and implementation of SEND in 2003, the FDA initiated an experimental program to test the method in 2007.
What are the timelines for SEND?
December 18, 2016
The SEND Implementation Guide (IG), SENDIGv3.0, is required for New Drug Applications (NDA), abbreviated new drug applications (ANDA), and certain biologics license applications (BLA).
December 18, 2017
SENDIGv3.0 mandates that SEND datasets be used for nonclinical data contained in all Investigational New Drug Applications (IND).
March 15, 2019
SENDIGv3.1 includes 2 new domains for safety pharmacology studies, mandates datasets required for NDA submissions and features improvements to other domains.
March 15, 2020
SENDIGv3.1 to be required for all IND submissions