SEND Submission Services
Frequently Asked Questions (FAQ)
1. What are SEND submission services?
SEND submission services involve the preparation, validation, and delivery of FDA-compliant nonclinical datasets in accordance with the CDISC SEND standard. These services ensure toxicology and pharmacology study data are structured, validated, and ready for electronic regulatory submission to the USFDA.
2. Why are SEND submission services mandatory for FDA submissions?
The US FDA requires nonclinical study data to be submitted in SEND format to enable standardized review, cross-study comparisons, and efficient regulatory evaluation. Non-compliant datasets may result in technical rejection or review delays.
3. What SEND submission services does Eniivance offer?
Eniivance provides comprehensive SEND submission services, including:
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SEND dataset preparation and mapping
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SEND QC and independent validation
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define.xml and nSDRG creation
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Legacy data conversion to SEND
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Pre-submission compliance and FDA readiness checks
4. Which nonclinical studies are covered under your SEND submission services?
Our SEND submission services support a wide range of FDA mandated nonclinical studies, such as:
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Single-dose and repeat-dose toxicity studies
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Safety pharmacology
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Genotoxicity and carcinogenicity
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Reproductive and developmental toxicity (DART)
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Local tolerance and other SEND-applicable studies
5. Can you support existing or partially completed SEND submissions?
Eniivance supports partial, failed, or legacy SEND submissions, including:
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Correction of validation errors
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define.xml and documentation updates
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Gap analysis against FDA SEND requirements
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Final submission-ready packaging
6. Are your SEND submission services compliant with current FDA requirements?
Our SEND submission services align with:
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CDISC SEND Implementation Guide (SENDIG)
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FDA Study Data Technical Conformance Guide
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FDA Technical Rejection Criteria for SEND
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Each submission undergoes independent QC to ensure regulatory acceptance and audit readiness.
7. Who typically uses your SEND submission services?
Our SEND submission services are trusted by:
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Pharmaceutical sponsors
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Biotechnology companies
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Contract Research Organizations (CROs)
We adapt to both in-house and outsourced SEND operating models.
8. How long do SEND submission services typically take?
Timelines depend on study complexity and data readiness:
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SEND validation-only services: 1–2 weeks
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Full SEND dataset preparation and submission: 2–4 weeks
We align delivery schedules with your regulatory submission milestones.
9. What makes Eniivance’s SEND submission services different?
Eniivance differentiates itself through:
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Strong nonclinical domain expertise
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Regulatory-focused SEND implementation
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High-quality, reviewer-ready datasets
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Flexible engagement and transparent communication
Our focus is not just SEND compliance but successful FDA submissions.
10. Can you provide expedited SEND submission services?
Yes we offer expedited SEND submission services for urgent regulatory timelines, subject to data availability and scope assessment.