About CDISC SEND
Xybion provides a CDISC SEND 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 SEND Compliant.
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About Xybion Corporation
At it's core, Xybion provides a suite of compliance software, laboratory operations solutions, preclinical software and quality management software that are designed to support global companies operating in highly regulated industries. Today’s global companies need solutions designed to accelerate their unique business processes. Xybion specializes in the development and delivery of flexible enterprise solutions that can be easily configured, integrated, or deployed out of the box to deliver the capabilities you need.
Our total solution and deliver model includes a cross-functional, yet integrated platform designed to provide compliance, quality and risk mitigation in a pervasive manner while reducing the need to run and support disparate systems. On average, Xybion saves its customers 20-30% on IT hardware, software and maintenance costs related to GRC technology