Is your nonclinical data compliant with CDISC SEND? The FDA mandate for using the CDISC Standard Exchange of Nonclinical Data (SEND) format for electronic submission goes into effect for studies started on or after December 18, 2016. The mandate is required for data contained in NDA, ANDA, and BLA filings. Lack of compliance in SEND submissions may result in a refusal to file (RTF) and delays.
In this express webinar led by Chris Lovejoy, learn how NCA data needs to be prepared, transformed, and formatted to be SEND-ready and how Phoenix tools can save time, reduce errors, and increase compliance. Chris, manager of deployment services for Phoenix, is a member of the Royal Pharmaceutical Society and has over two decades of experience working with leading pharmaceutical companies.