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.
Meet us at the Safety Pharmacology 2019 Annual Meeting to discuss our software’s capabilities for SEND export. Our team is waiting for you at booth #605.