SEND Data Standardization Services | CDISC SEND Experts

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 organisation 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.

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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.
• When is SEND Data Standardisation Required?

Understanding when SEND (Standard for Exchange of Nonclinical Data) data standardisation is required is crucial for compliance with regulatory agencies' submission requirements. The table below from FDA Standards catalog provides a summarised overview of when SEND is mandatory for different types of submissions, along with variations in date requirements for CBER (Center for Biologics Evaluation and Research) and CDER (Center for Drug Evaluation and Research).

The FDA's mandate for the implementation of the FDA SEND 3.0 on December 17, 2017, necessitated the submission of regulatory documents in an electronic formatSubsequently, on March 15, 2019, the scope expanded with the requirement of SEND 3.1 for IND studies, encompassing Safety  Pharmacology, particularly for cardiovascular and respiratory studies. Additionally, beginning March 15, 2023, CBER enforced the Standard for the Exchange of Nonclinical Data (SEND), further extending the regulatory requirements.

Our team is well-versed in the evolving SEND regulations and can guide you through the intricacies of compliance. Contact us today to learn how our expert services can help you navigate the changing landscape of nonclinical data standardisation.