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CDISC Standard for Exchange of Nonclinical Data (SEND)

We offer high quality SEND data output for preclinical research data from CROs and conduct normalization and validation of data to adhere to FDA compliant formats.

CDISC Standard for Exchange of Nonclinical Data (SEND) services is the mandatory submission format for nonclinical animal data to the US FDA. The recent SEND services implementation guide requires the submitting organization to structure and format the datasets which are computer readable.

The implementation of current data standards from the SEND helps to achieve cross-study querying which creates opportunities for data mining and meta-analysis by the pharma industry.

MakroCare provides the services to pharma organizations to collect and present their nonclinical data in compliance with SEND format for submitting them to regulatory authorities such as the US FDA.

MakroCare employs the utmost transparency and precision of data handling when it comes to SEND studies. Our programming and quality assurance units are very diligent with SEND implementation for GLP studies. Each dataset is subjected to rigorous data standards scrutinization and review.

We support for collecting and arranging the data as per SEND implementation rules typically found in:

  • Bullet Single-dose general toxicology
  • Bullet Repeat-dose general toxicology
  • Bullet Carcinogenicity studies
  • Bullet Safety pharmacology studies

Please reach us today to learn more about CDISC and to see if your datasets are in compliance with the FDA’s required CDISC standards.

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