As a toxicologist running multiple GLP and non-GLP studies, you and your team often plan budgets, study schedules, and contracting activities with your CRO and external vendor labs.
There is, often times, one critical-path topic that often appears as a line item in a Statement of Work between you and your CRO partner. That line item is the creation of a digital, standardized SEND dataset which is required for most studies to aid in the FDA’s review of your IND enabling submission package.
Naturally, this requirement can leave sponsors with a laundry list of questions:
- What study types require SEND?
- How long with SEND take to generate after the conclusion of the Study Report?
- Is SEND a gating issue for study planning? Will it be made available in time for my IND filing date?
- Will the SEND dataset pass validation checks, and be 100% traceable and consistent with the Study Report as part of the FDA’s key review check?
As one of the industry’s leading SEND preparers with over 10,000 studies standardized for submission, repository, and analysis since 2012 (including as an FDA contractor), we have received questions like these from Sponsors and CRO communities for years, and decided to share SEND specific insights to help equip you with a better understanding of the answer to the pressing question “Does my study need SEND?”
What is SEND, and why is it useful?
The Standard for Exchange of Nonclinical Data (SEND) is a data exchange standard developed by CDISC in close consultation with regulatory authorities and the Sponsor and CRO industry to guide the standardization of nonclinical studies into one format for use by regulatory authorities, i.e. the US FDA.
SEND datasets are the grouping of digital data in this harmonized format which can be analyzed regardless of the performing CRO or sponsor formatting of the Study Report. The SEND format is heavily based upon the Clinical Exchange Standard Study Data Tabulation Model (SDTM), with slight modifications for the complexities of the nonclinical studies.
The Challenge- Why SEND preparation is more complex than it looks
Why SEND Preparation Is More Complex Than It Looks
Creating compliant SEND datasets isn’t simply reformatting spreadsheets. It is a multi-layered data and metadata transformation process that often changes based on study type. Between tracking evolving regulatory requirements, translating diverse CRO data formats into standardized structures, and navigating FDA conformance rules, SEND preparation has become a specialized discipline that can consume significant time and resources without automation.
The key challenges:
- Version control across your portfolio – Different studies require different SEND versions (3.0, 3.1.1) and implementation guides (SENDIG-AR, SENDIG-DART, SENDIG-GeneTox) based on start dates and study types. Tracking which version applies to which study may be a question you have and which we will gladly answer.
- CRO format translation – Every CRO and lab delivers data differently, from “SEND-like” exports, to PDF to .xls. Transforming proprietary Excel templates, LIMS outputs, and custom databases into SEND’s standardized domain structures (DM, EX, LB, MI) requires custom mapping logic for each source.
- Validation complexity – FDA conformance rules check hundreds of requirements: controlled terminology accuracy, cross-domain relationships, required variables, and data type specifications.
What studies require SEND?
When submitting to the FDA, it is always best to check the official data standards catalog, but this blog serves to help you decipher (v11.0, March 2025) as of November 2025.
The SEND requirement disregards report status (draft, interim, final), as well as GLP status – even draft Non-GLP studies need SEND datasets for appropriate submissions.
SEND support for CDER began on December 17, 2016 (NDAs), and December 17, 2017 (INDs). Support for CBER began on March 15, 2023 for all submission types.
General Toxicology
Generally speaking, studies submitted to the following eCTD modules may require SEND: 4.2.3.1 Single-Dose Toxicity, 4.2.3.2 Repeat-Dose toxicity, 4.2.3.3 Genotoxicity, 4.2.3.4 Carcinogenicity, and 4.2.3.5 Reproductive and Developmental Toxicity.
Studies containing titles or themes including single dose toxicology and/or repeat dose toxicology, as well as carcinogenicity studies, respiratory or cardiovascular safety pharmacology, typically require the most up-to-date version of SEND (currently, version 3.1.1), with SEND 4.0 on the way for an anticipated 2026 release. These studies typically must fit within the above eCTD modules.
Animal Rule
Additionally, studies that are classified as “Product development Under the Animal Rule”, shortened to “Animal Rule”, for nonclinical efficacy require SENDIG-AR for submission to both CDER and CBER. The requirement for CDER began on March 15, 2022/2023 (NDA/IND), and CBER is set to begin in March 2027.
DART Studies
Reproductive toxicology studies also fit into another SEND format called “DART”, for Developmental and Reproductive Toxicology. Currently, Embryo-Fetal Development (EFD), and EFD portions of combination studies, are required to have SENDIG-DART formatting for submission to the US FDA. This requirement is in place as of March 15, 2023 (NDAs) and March 15, 2024 (INDs). *General toxicology studies performed with juvenile animals are submitted using “regular” SEND guidelines.
GeneTox Studies
The most recent SEND requirement is for the SENDIG-Genetox, for Genetic Toxicology studies; the requirement for submissions began on March 15, 2025. Studies that would fit into this model may include in vivo micronucleus or comet assays as endpoints.
The additional implementation guides, “-AR”, “-DART”, and “-GeneTox” are extensions of the current SEND implementation guide – as of writing, their current versions are extensions of SEND v3.1.1.
Study Start Dates and SEND Requirements
Some studies fall into a gray area where you study may not need SEND but may require a file known as a “simplified ts.xpt”. The FDA’s Technical Conformance Guide addresses these fringe cases; however, this is where a partnership with PointCross helps sponsors and CROs alike navigate these circumstances with confidence.
What makes PointCross different from other vendors?
After 25 years of data standardization, PointCross has become a leader in the SEND generation space. In fact, 1 of 4 studies submitted to the FDA run through PointCross.
Here are a few key points that differentiate PointCross when it comes to SEND:
- Traceability and Consistency- When a sponsor or CRO partners with us, they receive the assurance that PointCross guarantees 100% traceability and consistency with the Study Report
- Quality Assurance- PointCross implements a three-step QA plan that involves digitized reconciliation against the Study Report,because when it comes to data quality, your submission should NEVER be rejected by preventable errors.
- Data Validation- PointCross ensures each SEND dataset is validated against all applicable conformance rules of CDISC, FDA, and PMDA with its powerful validation program eDataValidator (eDV) as part of our flagship technology Xbiom™.
- Visual QC- all SEND datasets come with a complimentary visual demonstration of the data quality delivered on our Xbiom™ technology, which can be used as both a repository and powerful analysis platform.
Still not sure if your study needs SEND? We’ll let you know – FREE.
PointCross offers complimentary study qualifications. Often times based on the study alone and non-confidential study metadata, PointCross’ Data Standardization team is ready and willing to offer clarification, so you can proceed knowing whether your study requires SEND standardization with confidence.
In line with our core belief in pricing transparency, PointCross is able to provide you with a firm, fixed-price quote and guaranteed turnaround time at no cost, and without obligation. We have made this process simple by creating the SEND Quote Generator, a free and convenient way to help with budget and planning efforts when it comes to making your SEND generation decision. Simply answer a few high-level study parameters and receive an instant indicative quote.
As the FDA’s Technical Conformance Guide reminds us: “The ideal time to implement SEND is prior to the conduct of the study”.
Do you have a study and aren’t sure whether SEND is required? Contact PointCross today at ask@pointcross.com or use our SEND Quote Generator tool.