Core SEND Services
1
SEND Dataset Preparation
Structured transformation of curated nonclinical study data into CDISC SEND-compliant datasets aligned with regulatory requirements.
Capabilities :
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Dataset structuring and domain alignment
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Variable-level consistency checks
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Controlled terminology mapping
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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
Capabilities :
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Transformation of non-SEND structured source data into CDISC SEND format
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Study specific SEND mapping design
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Reusable mapping templates
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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.
Capabilities :
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Pinnacle 21 SEND validation
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Independent quality control review
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Structured issue tracking and resolution
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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.
Capabilities :
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SEND-compliant Define.xml generation
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Metadata and controlled terminology documentation
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Study Data Reviewer’s Guide preparation
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Consolidated SEND documentation package
Outcome: Complete and structured SEND documentation prepared for submission.
5
SEND Consultancy & Advisory
Advisory support for SEND feasibility, implementation planning, and submission readiness evaluation.
Capabilities :
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Interpretation of SEND IG requirements
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Technical and compliance advisory
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Study-level SEND feasibility assessment
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Alignment with current regulatory expectations
Outcome: Defined SEND strategy supporting submission readiness.
SEND Execution Workflow
Each engagement follows defined operational checkpoints to ensure structured SEND implementation and submission readiness.
01
Study Assessment
Scope definition and data evaluation
02
Mapping & Planning
Domain mapping and transformation design
03
Dataset Implementation
Generation of SEND-compliant datasets
04
Validation & Documentation
Technical validation and documentation preparation
05
Final Delivery
Submission-ready datasets and complete SEND documentation package