SEND (Standard for Exchange of Nonclinical Data) specifies a way to present nonclinical data in a consistent format, in order to improve exchanges, between 2 data collection systems. Submitting data in SEND format is required by the FDA starting January 2019.
To help you in this challenge, our software suite provides data tables under a SEND 3.1 compatible format for Respiratory, ECG and Vital signs domains. These tables are one of the components of a complete SEND report.
Such tables combined with additional information from Laboratory Information Management System (LIMS), provide you with a complete SEND data solution, from acquisition to submission.
This complete report can be produced by your in-house team or by a third-party solution like submit™-for-SEND from Instem (emka TECHNOLOGIES partner).
As we know that SEND is still an evolving standard, our team continuously adapts to ensure our customer compliance with regulatory guidance.