SEND GENERATION

SEND PREPARATION & 100% QC WITH LIMS DATA AND / OR FINAL STUDY REPORT

This turnkey service delivers submittable SEND datasets with Define.xml and nSDRG at industry’s most competitive rate.

PointCross generates SEND datasets that are 100% consistent with (and traceable to) the Study Report, including for data that may currently require custom domains, such as ADA. PointCross accurately regenerates the Trial Design and creates a Digital Study Report (DSR) to extract all essential metadata and summary tabulations for use in precisely populating SEND domains with LIMS subject data and study metadata.

The resulting SEND dataset is reconciled against the Digital Study Report ensure accuracy and consistency between the SEND data and the Digital Study Report (DSR). If SEND or subject data is unable to re-generate the published summary tables for the sponsor defined groups, both are checked until the error is corrected.

The DSR is available to customers who want the study in its original form and terminology for analysis and comparison to the Study Report, as the Study Director and Sponsor Toxicologists are used to seeing. The DSR is made available in Xbiom in a universally standardized control terminology for cross-study analysis or output to a SEND dataset with the selected SEND IG and CT, and is thus available for regulatory submissions with validation against all applicable conformance rules using the eDataValidator.

Business Benefits

  • Assured quality and 100% consistency with the GLP Study Report
  • Lowest cost in the industry, rapid delivery timeline with expedited processing available
  • Digital reconciliation ensures that SEND can regenerate all published summary tables in the Study Report
  • SEND datasets can be visualized and further analyzed on Xbiom™ including for cross-study analysis and comparison in an indexed and searchable repository
  • Digitized data is available in Study Report terminology (DSR) and in SEND-IG CT
  • SEND dataset, Define.xml and nSDRG meet TCG rules and avoids risk of rejection or program delay

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