Are your SEND datasets truly submission-ready?
Most prepared SEND datasets lack complete traceability to the Study Report (Section 8.2 TCG), and the gaps surface during regulatory review. SEND ASSURE is an independent check that reconciles 100% of your data to the report, confirms conformance to the current SENDIG, and hands back a clear remediation report before you submit.
SEND ASSURE Quote
step 2 of 3Your dataset, checked end to end.
Reconcile against the Study Report, validate conformance, analyze, and quote. The exact surfaces we use to assure your SEND.
Answer a few parameters
no sign-upAnswer a handful of parameters and the AutoQuote Generator returns a free, no-obligation QC estimate instantly. Need only an indicative number? See indicative cost.
Reconciliation vs Study Report
Study 7741-A · 14 SEND domains| Domain | Summary table | Study Report | SEND dataset | Status |
|---|---|---|---|---|
| BW | Mean body weight, wk 13 | 312.4 g | 312.4 g | ✓ Match |
| CL | Clinical obs incidence | 7 / 80 | 7 / 80 | ✓ Match |
| LB | ALT, high dose males | 48.2 U/L | 48.2 U/L | ✓ Match |
| OM | Liver weight, absolute | 9.81 g | 9.81 g | ✓ Match |
| MI | Hepatocellular finding | Minimal | Minimal | ✓ Match |
Every domain, every data point. The Consolidated QC Report traces each SEND value back to the published Study Report, so you submit with confidence instead of crossing your fingers.
The eDataValidator runs CDISC, FDA and PMDA rules plus extended PointCross quality checks, with an optional Pinnacle 21 cross-compare. The result is a clean, no-rejection submission.
Cross-study analysis
| Finding | Control | Low | Mid | High | Recovery |
|---|---|---|---|---|---|
| Hepatocellular | – | 1 | 2 | 4 | 1 |
| Renal tubular | – | – | 1 | 2 | – |
| Thymic atrophy | – | 1 | 2 | 3 | 1 |
| Body weight loss | – | – | 1 | 3 | 1 |
Delivered datasets land in a dedicated instance of Xbiom™ for review, visualization and cross-study comparison in an indexed, searchable repository, included for 30 days.
100% of audits reveal errors.
Across every SEND audit we have run, we find something, from minor traceability gaps to issues that trigger technical rejection. Here is what an independent SEND ASSURE review gives you.
Of audits reveal errors
Every SEND audit we have conducted surfaces issues, from minor traceability gaps to criteria that trigger an FDA technical rejection. Far better to find them before reviewers do.
See how it works →Traceable to your report
Section 8.2 TCG reconciliation across every data point.
Of FDA SEND submissions
Processed through our platform. Over 10,000 studies QC'd since 2012.
FDA rejections on record
We know what reviewers look for and we check it first, against the current SENDIG and the FDA TCG updated in March 2026.
SENDIG
traceability
criteria
Turnaround
Fast enough to fix issues before your IND filing.
Up to, in cost savings
Industry-leading efficiency on QC and remediation.
How we assure your dataset.
Digitize the report
We build a Digital Study Report that captures every published summary tabulation in the report's own terminology.
Regenerate summaries
We recompute every mean, standard deviation and incidence count directly from the prepared SEND dataset, at 100% depth.
Reconcile & flag
Regenerated values are compared to the audited report. Every discrepancy is captured, located and explained.
Validate & deliver
You get an eDataValidator conformance report against the current SENDIG, plus an annotated remediation report, with optional direct correction.
Find the issues, or fix them too.
QC + remediation report
We review it independently and hand back an annotated remediation report your team can act on.
- ✓100% reconciliation · every data point traced to the Study Report (TCG 8.2)
- ✓Conformance · eDataValidator against the current SENDIG, FDA & PMDA rules
- ✓Consolidated comparison report · quantitative & qualitative
- ✓Annotated remediation guidance · clear, actionable corrections
- ✓Xbiom™ access for review for 30 days
QC + direct correction
We review it and apply the corrections, then re-verify, so it is submission-ready.
- ✓Everything in QC + remediation, included
- ✓Corrections applied by our team · submission-ready xpt
- ✓Define.xml & nSDRG re-aligned to the corrected data
- ✓FDA TCG rules met, technical rejection criteria cleared
- ✓Industry-leading efficiency · see indicative cost
Every deliverable, defined.
Comparison report
100% traceability to the Study Report (Section 8.2 TCG), quantitative and qualitative.
Remediation report
Every discrepancy located and explained, with annotated, actionable correction guidance.
Define.xml & nSDRG check
Metadata and the reviewer's guide verified against the actual data in the dataset.
Corrected dataset
A fully corrected, submission-ready SEND dataset, re-verified against the report.
Need it built, not just checked?
If the dataset needs more than corrections, PointCross prepares submission-ready SEND from your LIMS data and Study Report, and can cut cost with Single Track Processing.
SEND ASSURE, answered.
What is SEND ASSURE? +
SEND ASSURE is an independent QC and validation service for already-prepared SEND datasets. PointCross reconciles 100% of the subject data to the Study Report (Section 8.2 of the FDA Technical Conformance Guide), checks conformance against the current SENDIG, and delivers an annotated remediation report so the dataset is submission-ready before it reaches the FDA. We hold a zero FDA rejection record across thousands of submissions.
How is this different from a spot-check QC? +
Manual spot-checks sample a fraction of the data. SEND ASSURE checks 100% of the subject data by regenerating every mean, standard deviation and incidence count from the dataset and comparing it to the published Study Report, so nothing is left unchecked.
What do I receive from SEND ASSURE? +
You receive a consolidated comparison report establishing 100% traceability to the Study Report, an eDataValidator conformance report against the current SENDIG, and an annotated remediation report with clear, actionable corrections. PointCross can also apply the corrections directly so the dataset is submission-ready.
How fast is SEND ASSURE? +
You can get a free, no-obligation indicative quote in under 60 seconds using the AutoQuote Generator, and a firm fixed-price quote within 24 hours once an NDA is in place and you share the dataset and Study Report. Typical review turnaround is 2 to 4 weeks, with up to 40% cost savings.
Will SEND ASSURE help avoid an FDA technical rejection? +
Yes. The FDA Study Data Technical Conformance Guide was updated in March 2026; datasets prepared before that may carry risk. SEND ASSURE checks your dataset against the current SENDIG and TCG rules, including Section 8.2 traceability, before reviewers do. In fact, 100% of the SEND audits we have conducted reveal errors, from minor traceability gaps to issues that trigger technical rejection criteria.
Do you QC datasets prepared by other vendors? +
Yes. SEND ASSURE is an independent service that works on SEND datasets prepared by any vendor or in-house team, against the corresponding GLP Study Report.
Have a dataset to check? Send it over.
Tell us about the dataset and study, or ask anything about SEND ASSURE. A PointCross specialist will get back to you, usually within one business day.
Prefer an instant estimate? Use the AutoQuote Generator →
Know it's right before you submit.
Get a free QC estimate in 60 seconds. Ready for a firm number? Share the dataset and Study Report and we'll have a fixed quote back within 24 hours.
