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Submission Ready CDISC SEND Deliverables

Structured, validated, and regulatory aligned SEND packages supporting global nonclinical submissions.

Core SEND Services

1

SEND Dataset Preparation

Structured transformation of curated nonclinical study data into CDISC SEND-compliant datasets aligned with regulatory requirements.

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Capabilities :

  • Dataset structuring and domain alignment

  • Variable-level consistency checks

  • Controlled terminology mapping

  • SEND-compliant dataset assembly

Outcome: Accurate, standardized, submission-ready SEND datasets.

2

SEND Conversion
& Mapping

Structured transformation of upstream nonclinical data into CDISC SEND through defined mapping and conversion workflows

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Capabilities :

  • Transformation of non-SEND structured source data into CDISC SEND format

  • Study specific SEND mapping design

  • Reusable mapping templates

  • Traceable raw-to-SEND transformations

Outcome: Consistent and scalable SEND conversion across studies.

3

SEND QC & Validation

Structured validation and quality review of SEND datasets aligned with regulatory technical standards.

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Capabilities :

  • Pinnacle 21 SEND validation

  • Independent quality control review

  • Structured issue tracking and resolution

  • Identification of compliance gaps prior to submission

Outcome: Technically validated SEND datasets prepared for regulatory review.

4

Define.xml & SEND Documentation

Preparation of structured and technically aligned SEND documentation supporting regulatory review.

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Capabilities :

  • SEND-compliant Define.xml generation

  • Metadata and controlled terminology documentation

  • Study Data Reviewer’s Guide preparation

  • Consolidated SEND documentation package

Outcome: Complete & structured SEND documentation prepared for submission.

5

SEND Consultancy
& Advisory

Advisory support for SEND feasibility, implementation planning, and submission readiness evaluation.

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​Capabilities :

  • Interpretation of SEND IG requirements

  • Technical and compliance advisory

  • Study-level SEND feasibility assessment

  • Alignment with current regulatory expectations

Outcome: Defined SEND strategy supporting submission readiness.

Have questions about SEND validation requirements or common submission challenges?

SEND Execution Workflow

Each engagement follows defined operational checkpoints to ensure structured SEND implementation and submission readiness

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submission-ready SEND datasets

01

Study Assessment

Scope Definition & Data Evaluation

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