The Path to SEND Compliance
The new SEND Submission guidance put forth by CDISC is upon us. All pharmaceutical companies, biotechs and contract research organizations (CROs) will soon be required to prepare data according to the CDISC formats. Sponsors will be required to use these formats by the FDA, and consequently, CROs are increasingly expected to provide study results in these formats. Working with commercial software vendors can help ease the burden of complying with evolving format standards, while also helping you leverage best practices in a GLP regulated environment.
Xybion, a leading provider of technology and services for highly regulated industries helps our clients become compliant with this critical new regulation. Learn about how to become SEND-compliant with our new infographic.
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Pristima Suite®, the Total Preclinical Lab Management Solution, 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 Team for non-clinical data collected from animal toxicology studies is the FIRST fully integrated end-to-end enterprise solution for tracking and managing veterinary facilities and research subjects throughout the pre-clinical research process.