Rupesh: SEND is a standardized format, elaborated by CDISC (Clinical Data Interchange Standards Consortium), used to organize, structure, and submit nonclinical study data for regulatory review.

This standardization helps regulatory agencies evaluate studies more efficiently and accurately, reducing review timelines and helping therapies reach patients faster. The SEND model provides a framework for presenting study data electronically, ensuring that endpoints are clear, consistent, and traceable.

SEND is based on the CDISC Study Data Tabulation Model but includes only the variables relevant to nonclinical or preclinical studies.

Rupesh: The FDA requires the use of CDISC SEND for specific nonclinical studies, including toxicology, safety pharmacology, and developmental and reproductive toxicology (DART) studies, submitted under Investigational New Drug (IND) applications, New Drug Applications (NDA), or Biologics License Applications (BLA).

The FDA’s SEND format requirement applies to the following study types:

• Single-dose toxicity studies
• Repeat-dose toxicity studies
• Carcinogenicity studies
• Safety pharmacology (cardiovascular and respiratory testing) studies
• DART (Embryo-Fetal Development studies)
• Genetic toxicology studies (including in vivo micronucleus and comet data)

The FDA also requires SEND-compliant datasets for electronic Common Technical Document (eCTD) submissions to the:

• Center for Drug Evaluation and Research (CDER).
• Center for Biologics Evaluation and Research (CBER).

As of 2025, the EMA has also begun piloting SEND in its proof-of-concept program, signaling broader international adoption. Today, regulators globally are aligning around standardized data formats to improve transparency and streamline submission review.

Rupesh: The FDA mandates that sponsors submit nonclinical study data in SEND format based on the study start dates specified in the FDA Data Standards Catalog (made available on FDA’s website) for each SEND Implementation Guide (SENDIG). SENDIG 3.0 was originally mandated on December 17, 2016 for NDA/Abbreviated New Drug Applications (ANDA) and certain BLA studies, and on December 17, 2017 for certain IND studies.

• SENDIG 3.1 submissions to CDER:
  • March 15, 2019: All NDA/ANDA and certain BLA enabling studies that have a study start date on or after this date
  • March 15, 2020: Certain IND enabling studies that have a study start date on or after this date
• SENDIG 3.1 submissions to CBER/SENDIG 3.1.1 submission to CDER & CBER:
  • March 15, 2023: All NDA/ANDA, certain BLA, and certain IND enabling studies that have a study start date on or after this date
• SENDIG-DART v1.1 submissions to CDER:
  • March 15, 2023: All NDA/ANDA and certain BLA enabling Embryo-Fetal Development studies that have a study start date on or after this date
  • March 15, 2024: Certain IND enabling studies that have a study start date on or after this date
• SENDIG-Genetox-v1.0 submissions to CDER & CBER:
  • March 15, 2025: All NDA/ANDA, certain BLA, and certain IND enabling studies that have a study start date on or after this date

Rupesh: Submitting nonclinical study data without SEND compliance can lead to regulatory delays, data integrity issues, and increased costs.

Non-standardized datasets are often difficult for reviewers to interpret, leading to clarification requests, reformatting demands, or even rejection of the submission. Inconsistent or incomplete data such as missing endpoints or unclear relationships between data points can further complicate review and create uncertainty around study outcomes.

In addition, poor traceability between raw data, study reports, and SEND datasets can raise concerns about data integrity and reliability in the regulatory review. The resulting need to correct, reformat, and resubmit data increases both cost and workload for sponsors and regulators, extending timelines and adding operational burden that sponsors can easily avoid through SEND adherence.

Rupesh: A dataset is considered SEND-ready when it fully adheres to the relevant IG and associated technical standards. Ensuring SEND readiness requires both technical validation and rigorous data quality controls.

Here’s a practical checklist you could use to perform an initial screening of your datasets for SEND readiness. It’s designed to help you spot potential gaps early and ensure your submission package aligns with the FDA’s expectations.

• Conduct gap analysis
  • Identify any inconsistencies in the study data and eventually non-compliance with SEND guidelines and FDA rules
• Verification of source data
  • Compare SEND datasets against the study report and raw data to confirm accuracy and consistency
• Follow the correct and/or latest SEND-IG version
  • Apply the appropriate version of the SEND-IG for your specific study type
• Map controlled terminology accurately
  • Check that all terms are correctly mapped and aligned with the latest CDISC controlled terminology
• Validate for compliance
  • Run datasets through a validation tool such as Pinnacle 21 and, if available, internal tools developed to identify and resolve any validation warnings or errors and eventually document non-adherence in nSDRG
• Ensure traceability
  • Maintain clear traceability between the source data, SEND datasets, and Define.xml files
• Conduct peer review and QC
  • Use a two-step quality control process and a standardized checklist to confirm completeness and accuracy
• Assemble the final submission package
  • Include all required components in FDA-compliant format: SEND datasets, Define.xml, and the nSDRG.pdf (nonclinical Study Data Reviewer’s Guide)

At Alira Health, our team can deliver validated, submission-ready SEND datasets that help our clients meet regulatory expectations with confidence. We can offer 360-degree support: from preparation of standardized datasets compliant with SENDIG v3.1, 3.1.1, SENDIG-DART v1.1, and SENDIG-Genetox-v1.0 to support in interactions with regulatory bodies.