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End-to-End SEND Submission Services
for Nonclinical Studies

Regulatory focused SEND expertise supporting pharma, biotech,
and CRO teams with FDA ready CDISC SEND submissions.

CDISC SEND Expertise

Secure Data Governance

Regulatory Alignment

Our SEND Services

SEND Dataset Preparation

SEND QC & Validation

SEND Conversion & Mapping

Define.xml & SEND Documentation

SEND Consultation & Advisory

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Why Partner with Eniivance

👉 Specialized expertise in CDISC SEND standards
👉 Deep nonclinical and regulatory domain understanding
👉 Proven capability with complex, real world source data
👉 Reviewer-ready, audit-supportive deliverables
👉 Flexible engagement tailored to study and program needs

Organizations We Support

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Pharmaceutical Sponsors

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Biotechnology Sponsors

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Contract Research Organizations

Nonclinical Research & Toxicology Teams

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Our Delivery Framework

A structured framework designed to support clarity, traceability, and regulatory confidence

Study Data
Assessment

Structured
Dataset
Development

Validation &
Quality Oversight

Submission
Ready Delivery

Standards and Regulatory Alignment

All deliverables are developed in accordance with applicable CDISC SEND Implementation Guides and relevant regulatory guidance, supporting submission ready datasets structured to regulatory expectations

Discuss Your SEND Submission

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