This turnkey service delivers submittable SEND datasets with Define.xml and nSDRG.
Service 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 resulting SEND dataset is reconciled against the digitized Study Report to make sure that both SEND dataset and the Digital Study Report (DSR) are accurate. The DSR is available to 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 dataset with the selected IG and CT is available for regulatory submissions with validation against all applicable conformance rules.
- SEND is informed by, and generated with the audited GLP Study Report
- Accuracy is built into the SEND preparation process
- Reconciliation ensures that SEND can regenerate all published summary tables
- Digitized data is available in Study Report terminology and in SEND-IG CT
- SEND dataset, Define.xml and nSDRG meet TCG rules and avoids TRC conditions
SEND customers receive their studies in Xbiom™ Nonclinical Insights to visualize and further analyze their completed SEND data