Software solution with SEND compatible outputs

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.

Download the brochure 

 

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