SEND ASSURE: 100% QC of PREPARED SEND DATASETS

SEND ASSURE - QC of SEND Datasets

This turnkey service provides a thorough check of CRO and 3rd Party Generated SEND datasets against the final PDF Study Report, its metadata, and tabulated summary data. Datasets are validated against all applicable conformance rules of CDISC, FDA, PMDA with eDataValidator; and SEND IG best practices. A report with remedial instructions is prepared for the customer to share with the SEND preparer, or PointCross can rapidly regenerate a corrected SEND dataset for delivery at 50% of the indicative cost.

SEND ASSURE begins with digitization of the Study Report to extract all essential metadata and summary tabulations, which is used with the 3rd Party prepared SEND dataset to check its ability to regenerate these summary tables as required by the TCG. The SEND dataset prepared by the CRO or 3rd Party is thoroughly reconciled against the Digitized Study Report (DSR) until both match. 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.

Additionally, a corrected SEND dataset is an option that is provided to the sponsor for use in a repository without any uncertainties of the 3rd party actually correcting their dataset according to the recommended errata. The DSR is also optionally available for those who want the study in its original form and terminology that the Study Director and Sponsor Toxicologists are used to seeing.

Business Benefits

  • SEND-ASSURE ensures consistency with the audited GLP Study Report as the trusted reference
  • SEND-ASSURE does NOT perform or rely on manual spot-checks; we check 100% of the subject data by regenerating the summaries in the study report
  • SEND-ASSURE checks that SEND dataset, Define.xml and nSDRG meet TCG rules and avoid TRC conditions

Generate an automatic, no-obligation, and instant quote for SEND ASSURE here.

SEND-ASSURE Deliverables if SEND preparer is responsible for changes

Service Deliverables
SEND-ASSURE Deliverables if SEND preparer is responsible for changes
Consolidated Quantitative and Qualitative Comparison Report with corrections needed in SEND xpt, nSDRG, Define.xml
SEND Assure Report, an Excel report providing the suggested corrections to the SEND Datasets, nSDRG and the Define.xml

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SEND-ASSURE Deliverables if SEND preparer is responsible for changes

  1. Return the SEND Dataset and Study Report provided for SEND-ASSURE quality checks.
  2. Consolidated Quantitative and Qualitative Comparison Report: An Excel report for sponsors informing or listing any actionable suggestions and observations that the Client may need to consider to remedy flaws in the SEND dataset prepared by a third party or unreconciled issues with the Study Report. This is an Excel file listing verification that every reported Mean, SD and Count in Study Report Summary Tables for quantitative data and incidence count summaries in categorical or qualitative domains such as CL, MA, and MI can be regenerated by the SEND dataset.
  3. SEND Assure Report: An Excel report providing the suggested corrections to the SEND Datasets, nSDRG and the Define.xml. This report provides the remedial corrections that should be applied by the Third Party SEND preparer or the Study Director.

SEND-ASSURE Deliverables if PointCross is expected to correct defects in SEND

Service Deliverables
SEND-ASSURE Deliverables if PointCross is expected to correct defects in SEND SEND Package (xpts, nSDRG, Define.xml, define.pdf)
Consolidated Quantitative and Qualitative Comparison Report with corrections applied on SEND xpt, nSDRG, Define.xml
SEND Assure Report, an Excel report providing the applied corrections to the SEND Datasets, nSDRG and the Define.xml

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SEND-ASSURE Deliverables if PointCross is expected to correct defects in SEND

  1. Submission Ready SEND dataset(s) with remedies applied based on Consolidated Quantitative and Qualitative Comparison Report from SEND-ASSURE
  2. Documentation of Consistency, Conformance and Quality Checks
    1. Consolidated Quantitative and Qualitative Comparison Report: 100% Consistency Checked Against Study Report for all SEND domains: Unresolved reconciliations entered into nSDRG. This is an Excel file listing verification that every reported Mean, SD and Count in Study Report Summary Tables for quantitative data and incidence count summaries in categorical or qualitative domains such as CL, MA, and MI can be regenerated by the SEND dataset.
    2. SEND Assure Report: An Excel report providing the applied corrections to the SEND Datasets, nSDRG and the Define.xml. This report may also provide the remedial corrections that should be applied by the Study Director.
    3. Conformance Validator: PointCross eDataValidator Report against applicable CDISC Conformance Rules, FDA Business rules for SEND, and PMDA/CDISC Define.xml. Comparative report with Pinnacle 21 Community Validator available on request.
  3. nSDRG (Nonclinical Study Data Reviewer’s Guide) as remedied: PDF of PhUSE template with annotations explaining standardization decisions relating to Study Design, Study Report following published expectations of FDA Reviewers.
  4. xml: Machine-readable XML and human readable PDF of metadata that describes SEND SDTM tabular dataset structure to inform regulatory reviewers which datasets, variables, controlled terms, and other specified metadata were used in the submitted study.