CDISC SEND Submission Resource Center

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