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

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).

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

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.

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

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)

When Is SEND Required?

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.