The U.S. Food and Drug Administration (FDA) requires SEND 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 Life Sciences launches an automatic SEND Quote Generation tool, intended to save industry time and effort in generating a highly competitive, indicative SEND generation or QC quote - including for those requiring a fast-track turnaround. PointCross SEND process ensures a 100% consistency and reconciliation against the GLP Study Report, and is accompanied by the nSDRG, Define, and validation files. SEND studies that PointCross processes or quality checks are also delivered on the Xbiom ™ visualization and analysis platform. Feel free to use the tool (link below) to generate a free, no-commitment indicative quote for your SEND needs, whether it is to generate the full SEND package or 100% QC an existing SEND dataset that you are preparing to submit. Link to SEND Quote Generation tool: https://pointcrosslifesciences.com/send-generation/
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