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 (version 3.1) 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. Molecular Connections 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.
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