Xybion provides a CDISC SEND compliant Submission solution as part of its preclinical software platform, Pristima. The FDA has issued the final guidance on standardized electronic data. Now, studies starting after Dec. 18, 2016, for applicable NDAs, BLAs and ANDAs, and studies starting after Dec. 18, 2017 supporting IND submissions, must be submitted in accord with electronic standards specified by FDA (SEND for nonclinical). Xybion is a registered solution provider for CDISC and can ensure your studies are CDISC SEND Compliant.
Learn More at FDA.gov
Pristima SEND Submission Management
Pristima Suite, provides a module to facilitate the FDA SEND standards for preclinical submissions. The Standard for Exchange of Non-Clinical Data (SEND) is an implementation of the Study Data Tabulation Model for non-clinical studies. This standard was developed by the Clinical Data Interchange Standards Consortium’s (CDISC) SEND.