SEND (Standard for Exchange of Nonclinical Data)
The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies which identifies a way to present nonclinical data in a consistent format. The format enables more efficient review of nonclinical data, offering improved data quality, accessibility, and predictability.
SEND is required for single- and repeat-dose General Toxicology and Carcinogenicity studies. Raw data of toxicology animal studies using SEND to support submissions of new drugs to the US Food and Drug Administration started in December 2016.
SEND specialists are active members of the CDISC SEND Consortium and PhUSE (Pharmaceutical User Software Exchange) nonclinical working groups. As an industry leader and participant in the development of SEND standards, we continuously review trends and changes to the implementation guidelines in order to assist our clients with the challenges of adhering to the evolving standards.
We use submit™ from the software vendor Instem to create SEND datasets, and Pinnacle 21 to ensure complete SEND compliance. The submit™ platform is the ideal solution for Altasciences due to its ability to integrate seamlessly with the Provantis®data collection system.
To ensure your nonclinical data is successfully accepted, we provide:
- SAS®Transport Files (XPT format)
- Define file (XPT format)
- Study Data Reviewers Guide [nSDRG] (DOC format)
Additional SEND services include:
- Dataset generation in multiple formats (XPT, XML, and XLSX)
- Create Data Definition "Define" file version 2.0
- Validation and quality control review
- Interim datasets
- Comprehensive dataset merged from multiple sources and data types
- Specific domains or whole studies for warehouse applications and legacy studies