SEND Conversion

1. Data Standardisation

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.

2. 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.

3. 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

4. Custom Domain Support

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

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

5.Delivered SEND Package

When you choose us, your delivered SEND package includes:

• Standardised SEND datasets in SAS Transport Files (XPT format).
• Define.xml.
• Nonclinical Study Data Reviewer’s Guide (nsdrg).
• Pinnacle21 validation reports.
  

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.

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.

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.