SEND Data Standardization Service for Nonclinical Studies
Nonclinical study data from disparate sources and in various formats (eg. LIMS, Excel, PDF) are converted to SEND standardized datasets with accompanying Define.XML, Define.PDF, Study
Reviewer’s Guide and Validation Report.

SEND Data Standardization Deliverables - SEND Standardized datasets in XPT format; - Define.XML and Define.PDF files compliant with CDISC specifications; - Study Data Reviewer’s Guide (nSDRG); - Validation reports generated by PointCross’ SEND-ASSURE service.

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SEND-ASSURE Service
For SEND data received from a CRO, our SEND-ASSURE service checks the sufficiency and reviewability of the SEND dataset and checks consistency against the Study Report. PointCross
checks all the quantitative data and spot checks of the qualitative data against incidence counts.

SEND-ASSURE Deliverables - Discrepancies found between the SEND datasets and Study Report; - Discrepancies identified in the SEND datasets against the FDA standards; - Errors and warnings identified during validation using PointCross and Pinnacle21 validators; - Suggestions to mediate any validation and SEND conformance issues identified by the PointCross data services team; - Validation reports: SEND dataset and Define file validation reports from both PointCross and Pinnacle 21 Validators.

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ToxVision – Nonclinical Data Viewer

We provide clients of our Data Standardization or SEND-ASSURE service with a free downloadable validator and SEND data browser. For advanced review capabilities clients may subscribe to ToxVision™, a SaaS (Software as a Service solution) for review and analysis of nonclinical study datasets in SEND format.

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