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SEND

FaviconSEND is defined in the CDISC SEND Implementation Guide (SENDIG), and it currently applies to single-dose toxicology, repeat-dose toxicology, and carcinogenicity studies, as per SENDIG v3.  SNBL USA utilizes submit™ from the software vendor Instem to create SEND datasets, and Pinnacle 21 to ensure complete SEND compliance.  The submit™ platform was the ideal solution for SNBL USA due to its ability to integrate seamlessly with our Provantis® data collection system. SNBL USA understands that Sponsors are looking to establish a partnership with CROs in regards to the generation of SEND datasets.  SNBL USA is ready to start these discussions.

Features & Capabilities of the submit suite include

SEND dataset generation (XPT, XML and XLSX formats)

Create Data Definition “Define” file (XML and PDF formats)

Automated translation of data to controlled terminology

SEND checker ensuring datasets conform to the IG rules

SEND editor for secure, fully-audited bulk dataset edits

Ability to merge files to create a single comprehensive dataset

The SNBL USA Client SEND Package

SAS Transport Dataset files (XPT format)

Define files (XPT and PDF formats)

Study Data Reviewers Guide (SDRG) (DOC and PDF formats)

SEND Domains

Demographics – DM

Comments – CO

Subject Elements – SE

Exposure – EX

Disposition – DS

Body Weights – BW

Body Weight Gains – BG

Clinical Observations – CL

Death Diagnosis – DD

Food and Water Consumption – FW

Laboratory Test Results – LB

Macroscopic Findings – MA

Microscopic Findings – MI

Organ Measurements – OM

Tumor Findings – TF

ECG Test Results – EG

Trial Elements – TE

Trial Arms – TA

Trial Sets – TX

Trial Summary – TS

Subject Characteristics – SC

Supplemental Qualifiers – SUPP-datasets

Related Records – RELREC

Pooling – POOLDEF

* Other domains available upon request

Contact our SEND Experts

Ask questions. We’re here to help.