CDISC Standard for Exchange of Nonclinical Data (SEND) Services

Enhancing Data Standardization for Regulatory Compliance and Nonclinical Study Efficiency

Introduction to CDISC SEND

The Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data (SEND) is a regulatory-mandated data standard developed to ensure structured, consistent, and interoperable nonclinical study data submission to regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the Pharmaceuticals and Medical Devices Agency (PMDA, Japan).

At Clievi, we specialize in SEND dataset preparation, compliance validation, and submission-ready data conversions, ensuring that nonclinical study data meets FDA and CDISC standards while optimizing data integrity, traceability, and efficiency for preclinical research.

Our CDISC SEND Services

1. SEND Dataset Creation and Standardization

• Study Data Mapping – Converting nonclinical study data from various formats into CDISC SEND-compliant datasets.
• Domain Development – Structuring study data into SEND-defined datasets, including Demographics (DM), Subject Disposition (DS), Clinical Observations (CL), and Laboratory Data (LB).
• Controlled Terminology Compliance – Applying CDISC-approved controlled terminologies to ensure regulatory alignment.
• Data Anonymization & Standardization – Processing data privacy and compliance measures for submission.

We ensure full compliance with CDISC SEND Implementation Guide (IG), FDA Study Data Standards (SDS), and SEND Controlled Terminologies.

2. SEND Compliance Review & Validation

• Regulatory SEND Compliance Checks – Ensuring adherence to FDA’s Data Standards Catalog and SEND Implementation Guide.
• Data Validation Using Pinnacle 21 – Running Pinnacle 21 (P21) validation tools for conformance checks and issue resolution.
• Gap Analysis and SEND Dataset Remediation – Identifying and fixing formatting inconsistencies, missing data, and standardization errors.
• Pre-submission Readiness Assessment – Evaluating data integrity and completeness for seamless regulatory acceptance.

Our SEND compliance process ensures error-free, submission-ready datasets that meet FDA SEND conformance rules and validation guidelines.

3. SEND Dataset Conversion & Legacy Data Transformation

• Legacy Study Data Conversion – Transforming historical nonclinical study data into CDISC SEND format.
• Custom SEND Dataset Development – Adapting unique preclinical study designs to SEND structure.
• SEND Pilot Study Implementation – Conducting small-scale SEND conversion tests before full dataset generation.
• Cross-Domain Data Linkage – Integrating nonclinical study results across multiple SEND datasets for a unified analysis.

We help organizations convert, standardize, and integrate nonclinical datasets to align with regulatory submission expectations.

4. FDA SEND Submission Support

• Submission-Ready SEND Packages – Delivering fully validated SEND datasets in SAS XPT format for FDA submission.
• SEND Dataset Documentation – Providing define.xml files, metadata reports, and reviewer’s guides for clear data interpretation.
• Regulatory Submission Strategy – Assisting with FDA Study Data Technical Conformance Guide (TCG) compliance.
• Post-Submission Support & FDA Query Resolution – Addressing FDA reviewer comments and technical data issues.

Our team ensures a smooth, efficient SEND submission process, minimizing regulatory rejections and data rework.

Why Choose Clievi for CDISC SEND Compliance?

• Regulatory Expertise – Profound knowledge of CDISC SEND Implementation Guide, FDA SEND Conformance Rules, and PMDA SEND Guidelines.
• Advanced Validation Tools – Utilizing Pinnacle 21, OpenCDISC, and SAS® tools for SEND data quality checks.
• Custom SEND Solutions – Tailored data standardization strategies for unique nonclinical study designs.
• End-to-End SEND Compliance Support – From dataset creation to final submission and regulatory response handling.
• Cross-Functional Team – Experts in preclinical research, biostatistics, data science, and regulatory submissions.

Deliverables of Our SEND Services

• Regulatory-Compliant SEND Datasets – CDISC SEND-formatted SAS XPT datasets ready for FDA submission.
• Define.XML Documentation – Structured metadata files that provide context for dataset interpretation.
• SEND Validation Reports – Compliance assessments using Pinnacle 21 and SEND Validator tools.
• Reviewer’s Guide & Study Data Standards Report (SDSR) – Supporting regulatory agency dataset reviews.
• Customized SEND Training & Consultation – Educating teams on SEND implementation, validation, and compliance strategies.

Industries We Serve

• Pharmaceutical & Biotechnology Companies – Supporting nonclinical data standardization for regulatory submissions.
• Contract Research Organizations (CROs) – Ensuring SEND dataset generation and submission compliance.
• Regulatory Affairs & Compliance Teams – Assisting in preparing FDA/PMDA-compliant SEND datasets.
• Preclinical Research Institutions – Standardizing toxicology, pharmacology, and safety data for global regulatory approvals.

Contact Us

Ensure flawless SEND compliance with Clievi’s expert data standardization and submission services. Contact us today for regulatory-ready, error-free SEND datasets.

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Website: www.clievi.com