Enhance Non-Clinical Submissions with Proven SEND expertise with AUXO!

What is SEND?

The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies. SEND provides a standard format for presenting nonclinical data, ensuring consistency in the organization and integration of study information. This facilitates the process of submitting nonclinical data to regulatory bodies, leading to greater coherence in presentation and transparency in the assessment and analysis of the information. Ultimately, SEND enables a more efficient and streamlined journey towards regulatory approval.

What is SEND Scope?

SENDIG's Core Focus: Designed for various study types, including:

  • Single-dose general toxicology
  • Repeat-dose general toxicology
  • Carcinogenicity studies
  • Respiratory and cardiovascular testing in safety pharmacology studies.

Diverse Study Support: Additional SENDIG versions cater to specific study types:

  • SENDIG-DART v1.1 and 1.2: Focuses on DART studies, particularly embryo- fetal development and juvenile animal toxicity.
  • SENDIG-AR v1.0: Supports data submission under the Animal Rule.
  • Ensuring Conformance and Quality:
    • Conformance rules ensure generated data structures conform to standards.
    • These rules identify and codify conformance criteria and case logic from the--SENDIG
    • Supports development of quality processes and tools for data integrity.

What we do?

AUXO! understand the importance of accurate and consistent data in the drug development process. Our SEND services make sures to deliver the SEND packages with quality.

Data Standardization

Our skilled professionals are well-versed in CDISC standards and will transform your raw nonclinical data into compliant SEND datasets. We create SEND datasets for a variety of study types, including pharmacokinetic, toxicology, and safety studies. Validation and Quality Control

Quality is our top priority. We perform rigorous validation checks on SEND datasets against FDA Business rules, FDA validation rules and CDISC Compliance rules to identify any inconsistencies, errors, or missing information. We conduct a thorough QC review against study reports to ensure that SEND datasets are consistent with the study report. Our quality control processes, guarantee that your data is accurate, reliable, and ready for regulatory submission.

Supported SENDIG Versions

Our expertise encompasses a range of SEND Implementation Guide (IG) versions, including:

  • SENDIG 3.1 and 3.1.1
  • SENDIG-Animal Rule v1.0
  • SENDIG-DART v1.1 and v1.2
  • SENDIG-Genetox v1.0

Custom Domain Support

We're equipped to handle data standardization for domains that may currently required to be standardized in custom domains, such as:

  • ADA (Anti-Drug Antibodies)
  • Nervous System Findings
  • Dermal and Ocular Measurements.

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