SEND: What You Need to Know for a Successful Regulatory Submission

Inotiv’s expert team delivers CDISC compliant regulatory submissions SEND packages, transforming your nonclinical study data into structured, submission-ready formats.

At Inotiv, we understand that preparing for a regulatory submission involves more than just running successful studies—it’s about presenting your nonclinical data in a standardized, regulatory-compliant format. That’s where SEND (Standard for Exchange of Nonclinical Data) comes in. Our experienced in-house team is ready to guide and support you through the SEND process, building and delivering SEND-ready datasets that meet the expectations set by the CDISC (Clinical Data Interchange Standards Consortium) standards. This includes datasets for submissions used by the U.S. Food and Drug Administration (FDA).

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What Is SEND and Why Does It Matter?

SEND is the “Standard for Exchange of Nonclinical Data,” built on the Study Data Tabulation Model (SDTM), which serves as the data model for tabulating study data in the clinical world. Both SDTM and SEND are created and governed by CDISC, a consortium of industry volunteers from around the world who contribute their expertise to develop standards usable by stakeholders globally. One of the primary aims of SEND is to aid regulatory reviewers, such as the FDA, by providing standardized datasets that can be seamlessly loaded into their visualization tools—allowing studies to be analyzed efficiently and effectively.

Your SEND package will typically include:

.xpt datasets
define.xml and stylesheet
nSDRG (Study Data Reviewer’s Guide)

We comply with all relevant documentation and standards:

SEND Implementation guides: SENDIG v3.1 & v3.1.1,
- Child-IGs: SENDIG-DARTv1.1 (Developmental and Reproductive Toxicology), SENDIG-ARv1.0 (Animal Rule), SENDIG-Genetox v1.0 (Genetic Toxicology)
CoDEx (Confirmed Data Endpoints for Exchange)
FDA Business and Validation Rules
SEND Conformance Rules
Controlled Terminology (via the Terminology Curation Group)
FDA Data Standards Catalogue
eCTD (electronic Common Technical Document) technical rejection criteria
Study Data Technical Conformance Guide (TCG)
CDISC/Phuse: White papers and knowledge-based articles

Who Is Behind SEND at Inotiv?

Inotiv's SEND team includes 10 dedicated SEND specialists who are deeply engaged in industry-wide regulatory discussions and implementation efforts and maintain active involvement with:

CDISC (Clinical Data Interchange Standards Consortium)
PhUSE (Pharmaceutical Users Software Exchange)
The FDA, including CDER (Center for Drug Evaluation and Research) and CBER (Center for Biologics Evaluation and Research)

Our team monitors evolving guidance and participates in collaborative forums to ensure our processes reflect current regulatory expectations.

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How Is a SEND Package Created?

We use a wide array of validated tools and systems to convert your study data into SEND-compliant datasets. This allows us to create new SEND datasets from external sources or even from legacy studies that were originally collected on paper.

LIMS Data Sources:

Provantis^®
Watson^™
WinNonlin^®
Acentos
Ponemah - ECG

SEND Tools & Platforms:

DefineNow^™
SENDirect

We apply industry-standard validation steps throughout the process to ensure clean, regulatory-ready submissions.

When Is SEND Required?

For FDA submissions, SEND requirements are based on the study start date and study type, as listed in the FDA’s Data Standards Catalogue.

SEND is generally required for:

General Toxicology

Single-dose studies
Repeat-dose studies
Carcinogenicity studies
Juvenile animal studies

Compliance_Rules_Law_Regulation_Policy_Business_Technology_Concept

Safety Pharmacology

Respiratory and cardiovascular assessments

Developmental and Reproductive Toxicology (DART)

Embryo-fetal development (EFD)

Other Categories

Animal Rule studies (e.g., natural history and efficacy studies)
Genetic toxicology (e.g., subject-level in vivo micronucleus and comet data)

What We Need From You

To ensure an efficient SEND build and submission, we rely on your team for timely and accurate input.

Before We Begin

Finalized study report
Confirmation that all study data are accessible within the appropriate systems or supplied in a usable format (.csv / .xlsx / .txt)
Any third-party data coordinated through the principal investigators (PIs)

During the SEND Process

Prompt assistance in resolving data errors
Clarification on missing or inconsistent information
Input when controlled terminology selections require confirmation

A collaborative approach keeps your timelines on track and avoids costly submission delays.

Why Choose Inotiv?

Our SEND team is not just a support function—we’re an integral part of your submission success strategy. With a deep understanding of the regulatory landscape and hands-on experience across a broad range of study types, we ensure your nonclinical data meet the highest standards of quality, traceability, and compliance.

Let’s work together to deliver your submission with confidence.