SEND (Standard for Exchange of Non-Clinical Data) is the standard data format and terminology required for the submission of preclinical data in support of IND or NDA submissions to the FDA. It specifies a way to collect and present nonclinical data in a consistent format.
Scantox is generating complete SEND packages, and our clients can rely on our regulatory expertise and guidance for all SEND requirements. SEND data are extracted from our Provantis® data capture system for in-vivo toxicology studies and all study data assembled, and each integrated SEND package receives a thorough QC review and validation check.
What the SEND Standard Includes
SEND (Standard for Exchange of Non-Clinical Data) is an implementation of the SDTM standard for nonclinical studies. SEND specifies a way to collect and present nonclinical data in a consistent format. SEND is one of the required standards for data submission to FDA.
All study data processed by the SubmitTM SEND solution (Instem) to produce one integrated SEND dataset package including Define.xml v2.0 file using DataDefine (Instem) and a Study Data Reviewer’s Guide (nsdrg). Rule conformance to standards which includes checks for conformance against published FDA Business and Validator Rules evaluated using Pinnacle 21 Community dataset validation too.
SEND’s Three Main Components
1 – definition of the structure of the standard – domains, variables, etc.
2 – a library of controlled terminology (which controls the vocabularies that can be used in some of the variables)
3 – a metadata file describing source and content of a set of SEND datasets.
Where the SEND Format is Required
The SEND requirements are continuously evolving covering increasing study types. Different versions of SENDIGs are on the Data Standards Catalog, and the submission of SEND nonclinical datasets is expected to continue to increase in the future.