This turnkey service provides a thorough check of CRO and 3rd Party Generated SEND datasets against the final PDF Study Report’s metadata and its tabulated data. Datasets are validated against all applicable conformance rules of CDISC, FDA, PMDA with eDataValidator; and SEND IG best practices.

SEND-ASSURE begins with digitization of the Study Report to extract all essential metadata and summary tabulations for use in populating SEND domains with the LIMS data and study metadata. The SEND dataset prepared by the CRO or 3rd Party is thoroughly reconciled against the Digitized Study Report (DSR) to make sure that both the SEND dataset and the DSR  is accurate. The DSR is available for those who want the study in its original form and terminology that the Study Director and Sponsor Toxicologists are used to seeing. The DSR is available in Xbiom in a universally standardized control terminology for cross-study analysis. 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.

Business Benefits

  • SEND-ASSURE relies on the audited GLP Study Report as the trusted reference
  • SEND-ASSURE does not rely on unreliable manual spot-checks , we do 100% check against the study report
  • Reconciliation ensures that SEND dataset can regenerate all published summary tables
  • SEND dataset, Define.xml and nSDRG meet TCG rules and avoids TRC conditions