Standard for Exchange of Nonclinical Data (SEND)
What is SEND?
SEND is the Standard for Exchange of Nonclinical Data. It is the standard data format and terminology required for the submission of preclinical single- and repeat-dose general toxicology studies in support of Investigational New Drug (IND) or New Drug Application (NDA) submissions to the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Review (CDER).
Why is SEND important?
According to CDISC, “SEND is one of the required standards for data submission to FDA.” An implementation guide for SEND is meant to support data typically found in single-dose general toxicology, repeat-dose general toxicology, carcinogenicity studies, and safety pharmacology studies. However additional implementation guides have also been created to support DART studies.
- Frontage can develop SEND datasets for your Bioanalytical and Toxicology studies from our Provantis® data capture system, and contributing reports utilizing the Submit™ software suite. Each dataset receives a thorough QC review and Pinnacle21 validation
- Frontage provides the following items to you, as required:
- SAS Transport Files (XPT format)
- Define File (XPT format)
- Nonclinical study data reviewer’s guide (nsdrg)
- Additional formats (XML and XLSX) are available upon request.