Abstract

Collectively called the Standard for Exchange of Nonclinical Data (SEND). the standards have been in development and recommended since early 2000s by Clinical Data Interchange Standards Consortium (CDISC) and the FDA.

They are now a requirement for preclinical studies started after December 2016 for New Drug Applications (NDA) and 2017 for Investigational New Drug (IND) submissions.

Who is this analysis report for?

• Toxicologists, Pathologists, Bioanalysts and others involved in creating data for in-vivo/animal studies
• Those responsible for submission of INDs or NDAs of in-vivo studies

What you will get out of this report?

• Learn how CDISC SEND standardization and FAIR go hand-in-hand
• Understand the benefits of FAIRification of data
• Typical challenges to look out for in your standardization journey