SEND – Overview In Light Of FDA Requirements

SEND (Standard for Exchange of Nonclinical Data) is a means of implementing CDISC Standard Data Tabulation Model (SDTM) to represent nonclinical data. SEND standards are based on SDTM domains and variables and include datasets and variables common to the clinical world such as Vital Signs (VS) and Disposition (DS) as well as additional variables and domains that are specific to nonclinical data such as Food and Water Consumptions (FW) and Organ Measurements (OM).

The standards were originally developed by CDISC as part of an initiative to expand the scope of data standardization to nonclinical animal studies and enable a faster, more efficient review of nonclinical data. To date, SEND has a special focus on supporting single-dose general toxicology, repeat-dose general toxicology and carcinogenicity studies. Safety pharmacology (i.e. cardiovascular and respiratory testing) is to be implemented in the next IG version. Also, embryo-fetal developmental (EFD) toxicity studies guidelines are currently in provisional status and are expected to be added to the SEND model in the future. The first SEND Implementation Guide was released on July 2011. Not long after, CDER announced acceptance of the guide’s standards and encouraged sponsors to use it. Currently, nonclinical submitted data in NDA, ANDA and BLA submissions must comply with SEND V3.0 in studies which started after Dec. 17, 2016. As far as IND submissions, SEND V3.0 will be mandatory for studies which will start after Dec. 17, 2017.

 

Submission TypeSEND IG VersionDate of RequirementIG Support
NDA, ANDA and BLA

 

 

3.0

 

 

3.1

17 Dec. 2016

 

 

15 Mar. 2019

Single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies

As for V 3.0 as well as for respiratory and cardiovascular testing done during safety pharmacology studies. Can be used to represent data for other study types.

IND3.0

 

3.1

17 Dec. 2017

 

15 Mar. 2020

As above

 

As above

 

When receiving a SEND submission, the FDA will review it using the Non Clinical Information Management (NIMS) system. This enables the FDA to perform a review more efficiently than previously done in paper submissions. The FDA will also run  validation checks to make sure the data is SEND-compliant. The validation rules for SEND submissions have been published by the FDA and are currently incorporated into Pinnacle 21 tool for sponsors who wish to validate their SEND data conformance.

The adoption of SEND standards has a major impact on the industry, as these standards have already become binding for all sponsors wishing to submit nonclinical data to the FDA. In practice, the standards are re-shaping the way in which nonclinical data is collected and submitted.

Implementing SEND standards requires expertise in the complete process of perceiving, planning, implementing and submitting nonclinical data. As failure to comply with SEND standards may result in rejection of the submission, it is essential that the submission is prepared in a proficient and competent manner by well-experience and knowledge staff.

 

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