SEND
Send, Standard for Exchange of Nonclinical Data, is a Standard for the presentation of Nonclinical Data in a uniform format by implementing the Standard Data table model (SDTM) of the CDISC. Currently, FDA requires SEND standard data for IND, NDA, ANDA, or BLA filings. Send data are XPT files, mainly including the study design information (TA, TE, TX, TS), administration information (EX), and test results information (BG, BW, CL, DD, FW, LB, MA, MI, OM, etc.). During the implementation, the data of LIMS system (Provantis system) are extracted by relevant software (Submit system for this institution), and the data are converted into standard data format and controlled terms. The resulting data set is verified by the Pinnacle21 software to ensure compliance with FDA requirements. The Define and NSDRG documents required by FDA will also be provided. Finally, the Send data set is generated, including XPT, DEFINE, NSDRG and other documents, and delivered to the client.
In 2018, JOINN completed the on-line of Submit system (supplier Instem) and provided Send standard data conversion service. This system can achieve data docking and conversion with Provantis system (supplier Instem) in the institution, which has good GLP compliance. To meet the requirements of FDA's SEND implementation guidelines (3.0 and 3.1), the SEND switch can be implemented, including single-dose toxicity tests, repeated-dose toxicity tests, oncogenic tests, and respiratory and cardiovascular system tests in safety pharmacological tests. Zhaoyan has a professional Send conversion team and has completed more than 50 Send projects for FDA approval.