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SEND Services

CDISC SEND FAQs 

 Nonclinical Regulatory Submission Questions

These CDISC SEND FAQs provide guidance on nonclinical dataset preparation, SENDIG standards, validation processes, and regulatory submission requirements. For detailed implementation support, review our CDISC SEND services.

General SEND Requirements

1. What are CDISC SEND submission services?

CDISC SEND submission services involve the preparation, validation, and delivery of nonclinical datasets in accordance with the SEND standard. These services ensure toxicology and pharmacology data are structured, validated, and ready for electronic submission to regulatory authorities such as the US FDA.

2. Why is SEND required for FDA submissions?

Regulatory authorities, including the US FDA, require nonclinical study data to be submitted in SEND format to enable standardized review, cross-study comparison, and efficient evaluation. Non-compliant datasets may lead to technical rejection or review delays.

3. Which nonclinical studies require SEND datasets?

SEND requirements apply to mandated nonclinical studies such as:

  • Single-dose and repeat-dose toxicity

  • Safety pharmacology

  • Genotoxicity and carcinogenicity

  • Reproductive and developmental toxicity (DART)

  • Other applicable toxicology studies

SEND Services and Support

4. What SEND services does Eniivance provide?

Eniivance supports the full SEND lifecycle, including:

  • Dataset preparation and domain mapping

  • Independent validation and QC review

  • define.xml and nSDRG preparation

  • Legacy study conversion

  • Pre-submission compliance assessment

5. Can you support partially completed or rejected SEND datasets?

Yes. Support includes:

  • Correction of validation errors

  • define.xml and documentation updates

  • Gap analysis against regulatory requirements

  • Final submission packaging

6. Do you offer expedited SEND support?

Expedited support is available for urgent regulatory timelines, subject to scope and data availability assessment.

7. Who typically engages your SEND expertise?

Services are utilized by:

  • Pharmaceutical sponsors

  • Biotechnology companies

  • Contract Research Organizations (CROs)

Engagement models support both in-house and outsourced workflows.

SEND Validation and Compliance

8. Are your SEND services aligned with current regulatory requirements?

All projects align with:

  • CDISC SEND Implementation Guide (SENDIG)

  • Applicable regulatory technical conformance guidance

  • Technical rejection criteria for SEND

Each dataset undergoes structured quality control prior to delivery.

9. What are common SEND validation errors before submission?

Common validation issues identified prior to submission include:

  • Dataset structure inconsistencies

  • Controlled terminology mismatches

  • Incomplete define.xml metadata

  • Domain-level mapping errors

  • Findings not aligned with SENDIG requirements

Structured validation review helps identify and resolve such issues before submission.

10. Is independent SEND validation recommended before submission?

Independent validation is often recommended to ensure datasets meet technical and regulatory expectations prior to submission. A structured review can identify mapping inconsistencies, validation findings, and documentation gaps that may affect regulatory acceptance.

Advanced SEND Implementation Considerations

11. What is SENDIG and which version should be used for submission?

SENDIG (SEND Implementation Guide) defines the structure and rules for preparing nonclinical datasets in SEND format. Regulatory authorities specify acceptable SENDIG versions in their technical guidance. Dataset preparation should align with the version required at the time of submission.

12. What is the typical timeline for SEND dataset preparation?

Timelines depend on study complexity and data readiness:

  • Validation-only support: approximately 1–2 weeks

  • Full dataset preparation: typically 2–4 weeks

Delivery schedules are aligned with submission milestones.

13. How should legacy nonclinical data be converted to SEND format?

Legacy nonclinical datasets often require structured mapping to SEND domains, controlled terminology alignment, metadata preparation, and validation review. A systematic conversion approach helps ensure historical studies meet current regulatory submission standards.

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