The U.S. Food and Drug Administration (FDA) requires SEND (Standard for Exchange of Nonclinical Data) as a standard for nonclinical study data submission to the Center for Drug Evaluation and Research (CDER). SEND is a data standard mandate of CDISC SDTM standard for nonclinical studies and provides a framework to collect and present individual animal study data. PointCross works with several Sponsors’ and CROs to support in preparation of submission ready SEND datasets with Define.xml and nSDRG, at industry’s most competitive rate.
PointCross is a Platinum member of CDISC consortium and PHUSE teams and participates in the development of SDTM and SEND standards.
Our SEND Data Standardization offerings
PointCross is a leading provider (with about 25% of the market share) for SEND Data Standardization of Nonclinical Studies packaged for submission to the FDA SEND dataset requirements– most commonly for IND submission. Our SEND data services includes:
SEND Dataset package generation: PointCross rapidly takes all of the source data generated by the CRO to generate the final SEND dataset and fully reconciles this against the final Study Report (here, we generate an indexable, machine-readable, and searchable Digital Study Report). We convert all your source data into a Universal Data Model (UDM) that allows for automated conversion of your selected CDISC SEND IG version (3.0, 3.1 etc.) and CDISC Controlled Terminology (CT).
SEND-ASSURE quality and consistency checks: We regard consistency with Study Reports as vitally important, dating back to 2015. The Study director signs the PDF study report after the audit, and the principle investigator signs off on any study domain that were done at laboratories or CRO’s. This PDF is the authoritative reference for the study. It is produced, under GLP, from the as-collected data by the Study Director or Investigator’s team. The SEND data set uses the same source of as-collected data, but then gets processed by a SEND qualified team.
Since the Study Report and the SEND dataset are “end products” generated by two independent processes from a common source, it is easy to see why the two end-products end up with inconsistencies. Sponsors send their SEND datasets to us for SEND-ASSURE quality check i.e., 100% quality can consistency checks, where we actually extract all essential metadata and summary tabulations out of the signed Final Study Report and reconcile it against the completed SEND datasets. The SEND-ASSURE service generates a complete list of corrections and recommendations to be completed in order for the SEND dataset to be considered submittable.
What studies (Nonclinical / Preclinical) require SEND datasets?
PointCross SEND Dataset generation and SEND quality check services for nonclinical studies includes the following, but not limited to:
- General Toxicology
- Embryo Fetal Development
- Fertility & Early Embryonic Development
- Pre- / Post-Natal Development
- Juvenile Studies
- Safety Pharm/ CNS Pharmacology
- Distribution or Impurities Studies
- Local Tolerance Study
- Immunogenecity or Immunotoxicity Studies (Cytokines, FACS, IHC)
- Tumorogenecity and Omics (gene, protein, transcriptomics) Studies
- Pharmacodynamic Drug Interactions and ADA
- Respiratory Pharmacology
- CardioVascular Pharmacology
- Efficacy-Xenograft Studies
- Animal Rule Counter-Measures or Efficacy Studies
Why use PointCross SEND dataset services?
- Assurance of quality and complete compliance with the GLP Study Report.
- Highly automated, rigorous transformation and standardization service of data for nonclinical studies.
- Significant Lower price of about 40% compared with the competitors in the sector.
- SEND datasets generated are guaranteed to be 100% consistent with the Study Report in addition to being conformant to the regulatory requirement.
- Faster turn-around time and expedited delivery available.