SEND – The Standard for Exchange of Non-Clinical Data

What is SEND?

SEND is the pre-clinical equivalent of the SDTM.  It is a content standard for variables to be used in animal studies.  SAS datasets are used to transport data to the regulatory authorities.  The CDISC Define.xml model holds the metadata for these datasets.

SEND allows for the creation of libraries of standard animal dataset metadata for drag and drop re-use.  It is a means for sponsors to communicate with animal houses the datasets they expect to gather in their trial.

Business Benefits of Using SEND

Standardized Dataset Format

SEND facilitates communication between CRO’s and sponsors or sponsors and regulators. 

Regulators in particular benefit from the standard: the FDA can begin to perform meta-analysis of safety across new drug entities from multiple companies for example.  The FDA has invested significant sums of money in data warehouse tools for such a purpose (JANUS) and in training reviewers to understand these structures.

With standardized variables and domains, queries to pharma companies about the structure of their submissions should be reduced.