SEND - Standard for Exchange of Non-clinical Data

CDISC (Clinical Data Interchange Standard Consortium) SEND is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for non-clinical toxicology and safety pharmacology studies and is intended to provide an accurate standardised electronic representation of information included in study reports.

SEND data standard enables to streamline data interchange between sponsors, providers and the FDA.

The current SEND 3.1 supports the following study types:

  • General toxicology
    • GLP/ Non-GLP
    • Single-dose/ Repeat-dose
    • Carcinogenicity studies
  • Safety pharmacology
    • Cardiovascular studies
    • Respiratory studies

For each study Evotec provides the complete set of submission-ready SEND datasets, including related documents such as: nSDRG, Define file and validation reports.

SEND activities can serve also as part of an INDiGO programme, Evotec’s solution designed to de-risk and accelerate IND-enabling programmes.

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