CDISC SEND Electronic Data Submission Mandate
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 New Drug Applications (NDA), abbreviated new drug applications (ANDA), and certain biologics license applications (BLA). Submissions to the FDA that do not comply with CDISC SEND requirements could receive a Refuse to File (RTF) for NDAs and BLAs, or Refuse to Receive (RTR) for ANDAs.
Get Ready for CDISC SEND – Phoenix SEND Workflow Template
The SEND Workflow Template prepares data in the format required by the FDA and other regulatory agencies for electronic submission. Once your non-compartmental analysis (NCA) is completed in Phoenix® WinNonlin™, the SEND Workflow Template automates the creation of the SEND Pharmacokinetic Parameters (PP) and Pharmacokinetic Concentration Data (PC) domains in the required SEND format for electronic submission.
Accelerate SEND Submissions
Regardless of whether you receive bioanalytical data in a CDISC/SEND SDTM format from an external partner, an internal biostatistics and data management group, or the data needs to be converted, the Phoenix SEND Workflow Template can be used to prepare your NCA data in a SEND-ready format for regulatory submission. Phoenix Technology Services works closely with you to perform a gap analysis to map data from your NCA workflow into the SEND Workflow Template.
Benefits of the SEND Workflow Template
- Saves time with automated process
- Reduces errors
- Increases compliance
- Phoenix SEND Workflow Template that creates data in the standard SEND format as required by the FDA
- Phoenix plugin that outputs the data created in the workflow template into a file format accepted by the FDA
- Example of a completed project with example NCA analysis and data mapped to the template
- Specification document that shows how the template maps to the SEND format
- Up to 10 days of Phoenix Technology Services for training, compliance gap analysis, implementation, and modification of the SEND Workflow Template and Plug-in to meet customer requirements
|Certara is a CDISC Registered Solutions Provider|