Your GLP Study Report, machine-readable
PointCross generates a digitized, machine-readable file from a draft or final nonclinical GLP Study Report. The DSR comes as a by-product of our SEND data standardization and SEND ASSURE services, or as a standalone deliverable, giving Sponsors and CROs an indexed, searchable repository of studies for cross-study analysis.
| Field | Value | Source |
|---|---|---|
| STUDYID | 9042-TOX-13W | TS |
| SPECIES | RAT | TS |
| Body weight, M, HD | 412.6 g | BW summary |
| Trial sets | 8 arms | TX / TA |
SEND datasets are not always what the report says
When SEND was first mandated by the FDA in 2016, many datasets generated across the industry lacked quality and were frequently inconsistent with the audited GLP Study Reports. Rigorous quality checks surface these issues immediately.
A digital study report in columnar tabulation
The DSR is a natural by-product of our high-fidelity SEND data standardization and our rigorous, automated SEND quality check.
All required metadata and summary tables
Everything the Study Report carries, in machine-readable form, available for use in TS.xpt and the other SEND domains.
A complete set of Trial Design domains
Informed by the actual study design used in the Study Report, so the structure of the study is captured exactly as conducted.
The Study Director’s conclusions, digitized
Digital extracts of the Director’s conclusions are carried into the DSR, in the same terminology used in the report.
Machine-readable, terminology-faithful
Delivered as columnar tabulation that any SEND visualization tool can read, unencumbered by the PDF study report.
One digital record, several jobs
Reconcile and QC the SEND dataset
The DSR re-generates the summaries published in the Study Report for the same cohorts and groups, so the SEND dataset can be QC’ed and reconciled against them. After reconciliation, the DSR is an accurate digital representation of the report and the SEND data accurately reflects it.
Open in any SEND visualization tool
The DSR is readable by any SEND visualization tool, including the Xbiom platform, which includes a Reconciler and eDataValidator for performing all checks on the SEND dataset.
Explore Xbiom →Build a searchable study repository
For Sponsors and CROs who want an indexed, searchable repository of legacy studies, the DSR enables cross-study analysis against other digitized studies, and even ongoing ones.
Benefits of the SEND Digital Study Report
Four ways the DSR comes to you
With SEND standardization
Generated automatically as part of our high-fidelity SEND data standardization process.
With SEND ASSURE / QC
Produced during our rigorous, automated SEND quality check, at low added cost.
As a separate deliverable
For Sponsors and CROs that want an indexed, searchable repository of legacy studies.
As an alternate to SEND
When a DSR is required in place of SEND, this service applies directly.
The Digital Study Report, answered
What is a Digital Study Report (DSR)?+
How is the DSR generated?+
How does the DSR help QC a SEND dataset?+
What tools can read the DSR?+
Can the DSR replace SEND?+
Want a DSR for your studies? Tell us about them.
Tell us about the study reports or datasets you have, or ask anything about the Digital Study Report. A PointCross specialist will get back to you, usually within one business day.
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Turn your Study Reports into digital, searchable data
Get a machine-readable Digital Study Report, reconciled to your SEND data and ready for cross-study analysis. Request a no-obligation quote to get started.
