Using Data Visualization Tools on SEND Datasets: A Graph is Worth a Thousand Data Points

SEND [Standard for Exchange of Nonclinical Data] is more than just a tool SEND test submission with Covance. Photo of binary codeto facilitate nonclinical data submissions to the FDA. SEND datasets are rich in information, albeit in a form that’s time-consuming for non-experts to parse. With the right visualization tools, SEND data sets can inform nonclinical programs and yield important insights.

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What’s Changing in SEND 3.1?

The SEND [Standard for Exchange of Nonclinical Data] Implementation Guide v3.1, “SEND 3.1,” changes the model for the reporting of cardiovascular and respiratory endpoints.

SEND 3.1 became effective 15 March 2019 for NDA/BLA submissions; and it will become effective 15 March 2020 for IND submissions, overlapping with the effective period of the previous version, SEND 3.0. (See chart below.)

SEND 3.0 and 3.1 roll-outs

Chart 1. SEND 3.0 and 3.1 roll-outs.

Some additional regulatory considerations during this transition period include:

  • The SEND version required for your submission is determined by the study start date (aka protocol finalization date).
  • If you are including non-GLP studies in a regulatory submission, a SEND dataset is also required.
  • If you have legacy studies in your submission, an abbreviated TS file (Trial Summary file) is required for each one.

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