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.

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.

Selection of SEND variables for each domain: All existing domains are embedded in our study manager software, including the 4 domains from the « Trial Design » class
Semi-automatic population of the domains wherever possible. Data tables automatically filled for the following findings classes : ECG test result, Cardiovascular test result, Respiratory test result, Vital signs
Choice lists available with the full CDISC terminology: more than 650 variables and about 10 000 terms, to help picking the correct words without typos.
Management of the format codes from the implementation guide, and definition of custom sets of terms where no format code is imposed
Preview SEND-formatted data ready to be exported as .xls or .csv files
No need to re-validate your acquisition system. SEND export module works with any
IOX version.