SEND
SEND (Standard for Exchange of Nonclinical Data) is a standard implemented using the CDISC Standard Data Tabulation Model (SDTM) to present nonclinical data in a uniform format.
Currently, the FDA requires SEND-formatted for submission of IND, NDA, ANDA, or BLA. SEND data is provided as XPT files and mainly includes study design information (TA, TE, TX, TS), dosing information (EX), and results (r.g., BG, BW, CL, DD, FW, LB, MA, MI, OM). During implementation, data is extracted from the LIMS system via relevant software and converted into a standard format using controlled terminology. The generated datasets are validated using software like Pinnacle21 to ensure compliance with FDA requirements. The required Define and study data review guide (NSDRG) files are also provided. The delivered SEND datasets include XPT, Define, NSDRG, and other files.
Our facility provides SEND datasets compliant with FDA SEND Implementation Guide requirements (SEND3.1, SEND DARTV1.1, SENDIG-GeneTox v1.0). We support SEND conversion for studies including single-dose toxicity, repeated-dose toxicity, carcinogenicity, respiratory and cardiovascular system safety pharmacology, embryo-fetal development toxicity, and micronucleus assay. JOINN has a dedicated SEND conversion team with experience in hundreds of SEND projects submitted to and approved by the FDA.
