Digital Study Report

PointCross Life Sciences generates a digitized, machine readable, file from a draft or final Nonclinical GLP Study Report (Digital Study Report – DSR) either as a byproduct of our SEND Data Standardization or SEND-ASSURE service, or as a separate deliverable service for Sponsors and CROs that desire an indexed, searchable repository of legacy studies for cross-study analysis. If a DSR is required as an alternate to SEND, this service is applicable.

When SEND was first mandated by the FDA in 2016, many of the SEND datasets that were being generated within the industry lacked quality, and are frequently populated with data inconsistent with the audited GLP Study Reports. Rigorous quality checks immediately surface these issues, and 100% of all studies that PointCross has QC’ed have uncovered critical errors that indicate conformance or consistency issues.

A recent check in March 2022 of 32 studies done by 3^rd party SEND providers showed that not a single study was safe to be used for regulatory decisions. Each study had incorrect trial design domains, wrong study metadata, incorrect exclusion flags, incorrectly populated data, or missing data published in the Study Report.

The DSR is a Digital Study Report available in machine-readable columnar tabulation. DSR is a natural by-product of our high fidelity SEND data standardization process -or our rigorous SEND quality check – done with automation.  DSR contains all the required study metadata and summary tables in the study report, as well as a complete set of Trial Design domains as informed by the actual study design used in the Study Report. DSR also carries the digital extracts of the Study Director’s conclusions.

DSR serves multiple use cases: for one, it is used in QC’ing and reconciling the SEND dataset by  re-generating the summaries published in the Study Report for the same cohorts and groups.

After reconciliation, the DSR is an accurate digital representation of the Study Report and the SEND data accurately reflects the Study Report.

Secondly, DSR is readable by any SEND visualization tool, including the Xbiom platform, which includes a Reconciler and eDataValidator for performing all checks regarding the SEND dataset.

• Capture Study Director’s conclusion in digital format
• Visualize clinical observations and numerous parameters for in-depth analysis and cross-study analysis against other digitized studies (or even ongoing studies)
• Study Report can be analyzed and visualized with digital data unencumbered by the PDF study report, and in the same terminology as in the Study Report
• QC SEND data with high quality, rapid turnaround, and low cost
• Availability of all study metadata for use in TS.xpt and the other SEND domains
• Low cost if it is a by-product of SEND or QC