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.