Ensuring FDA Compliance with SEND Dataset Requirements: PointCross’s Comprehensive Solutions
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 the industry’s most competitive rate.
PointCross is a Platinum member of CDISC consortium and PHUSE teams and actively 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 include:
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 to ensure the SEND dataset is ready for FDA submission.
What studies (Nonclinical / Preclinical) require SEND datasets?
PointCross SEND Dataset generation and SEND quality check services for nonclinical studies include, but are not limited to, the following:
- 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 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, ensuring that your data meets FDA SEND data requirements.
- Faster turn-around time and expedited delivery available.
Our experts are well-versed in CDISC SEND submission solutions, ensuring that your datasets are fully FDA SEND compliant. Whether you need assistance with CDISC conversion, guidance on FDA data submission requirements, or are looking for a reliable nonclinical data software to streamline the process, PointCross has got you covered.
PointCross is your trusted partner for achieving complete compliance with FDA SEND dataset requirements. Our proficiency in SEND Data Standardization for Nonclinical Studies, coupled with our commitment to quality, consistency, and competitive pricing, makes us the ideal choice for organizations seeking seamless FDA submission solutions. Let PointCross help you streamline your data preparation and elevate your SEND dataset submissions to the highest standard. Additionally, our comprehensive SEND Generation services leverage our expertise to rapidly compile all necessary source data from Contract Research Organizations (CROs) and generate compliant SEND datasets, ensuring that your data is prepared and ready for smooth FDA submission. With PointCross as your partner, you can have confidence in the accuracy, completeness, and regulatory compliance of your SEND datasets, empowering you to navigate the FDA submission process with ease and efficiency.