Achieve compliant and secure FDA (eCTD) submission requirements with accurate and timely SEND datasets.

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 tool.

Clinical Data Interchange Standards Consortium – Standard for Exchange of Nonclinical Data:

There are three principle components to the standard: (1) the 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) and (3) a metadata file describing the source and content of a set of SEND datasets.

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.