MC-RWE >CDISC Standard for Exchange of Nonclinical Data – SEND Services
CDISC Standard for Exchange of Nonclinical Data – SEND Services
The CDISC Standard for Exchange of Nonclinical Data (SEND) is the mandate submission format for nonclinical animal data to the US FDA. The recent SEND implementation guide (version 3.1) offers 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. Molecular Connections provides the services to pharma organizations to collect and present their nonclinical data in consistent with SEND format for regulatory submission such as US FDA.
We support for collecting and arranging the data as per SEND implementation rules typically found in:
- Single-dose general toxicology
- Repeat-dose general toxicology
- Carcinogenicity studies
- Safety pharmacology studies