SEND compliance, without the slowdown.
PointCross turns your LIMS data and Study Report into submission-ready SEND datasets, fully reconciled, validated and ready for the FDA. Watch it happen, then get an instant quote in 60 seconds.
SEND AutoQuote Generator
step 2 of 3One platform, end to end.
Quote, generate, reconcile, validate and analyze. Click through the surfaces your team will actually use.
Answer a few parameters
no sign-upAnswer a handful of study parameters and the AutoQuote Generator returns a free, no-obligation estimate instantly. No calls, no back and forth.
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.
What leading CROs and sponsors already know.
SEND compliance doesn't have to slow you down. Here is what teams already working with PointCross count on.
A SEND quote in under a minute
No calls, no back and forth. The AutoQuote Generator returns a free, no-obligation estimate the moment you answer a few study parameters.
Try the AutoQuote Generator →Checked against the Study Report
Every domain, every data point, in a Consolidated QC Report.
Firm fixed price within a day
Share your protocol under NDA and get Standard and Expedited pricing back inside 24 hours.
Single Track Processing cuts cost
We generate the Study Report and the SEND dataset from one single data source, removing the redundant work that drains your budget.
data source
Your quote holds for a year
Same price, same turnaround, for a full calendar year. Plan ahead without watching the clock.
FDA rejections
Across 10,000+ datasets delivered. The no technical-rejection guarantee is built in.
From Study Report to submission-ready SEND.
Digitize the report
We build a Digital Study Report capturing the Trial Design, metadata and published summary tabulations in the report's own terminology.
Populate domains
LIMS subject data is mapped into SEND domains against the regenerated Trial Design, including custom domains such as ADA.
Reconcile
The dataset is reconciled against the DSR. If it cannot regenerate a published summary table, we fix it until it does.
Validate & deliver
You get a submittable package with Define.xml and nSDRG that meets TCG rules, backed by the no-rejection guarantee.
Pick the track that fits your study.
Submission-ready SEND
Full documentation of consistency, conformance and quality, ready for the FDA.
- ✓SEND package · xpt, nSDRG, Define.xml, define.pdf
- ✓Consistency · 100% reconciled against the Study Report
- ✓Conformance · eDataValidator, optional Pinnacle 21
- ✓DSOAR report if needed, to correct source or report
- ✓Xbiom™ access for 30 days
Legacy & repositories
SEND-like datasets for legacy studies, ready for analysis or repositories.
- ✓SEND dataset · xpt files for analysis or repositories
- ✓Consistency · 100% checked against the Study Report
- ✓Conformance · eDataValidator + quality rules
- ✓DSOAR report to correct source or report
- ✓Xbiom™ access for 30 days
Every deliverable, defined.
SEND dataset
Submission-ready SDTM tabulation datasets across all applicable SEND domains, populated from your LIMS data.
Comparison report
A consolidated quantitative and qualitative comparison, 100% consistency-checked against the Study Report.
nSDRG
PhUSE-template PDF annotated to explain standardization decisions, following FDA reviewer expectations.
Define.xml
Machine and human-readable metadata describing the SEND dataset structure for regulatory reviewers.
Digital Study Report
Your study in its original terminology, standardized in Xbiom™ for cross-study analysis. See the DSR.
eCTD table generation for Module 4
If producing eCTD tables is a manual or time-intensive job, PointCross can take it off your plate, so your people can focus on the science.
SEND generation, answered.
How fast can I get a SEND quote? +
You can get a free, no-obligation indicative quote in under 60 seconds with the AutoQuote Generator. For a firm number, put an NDA in place and share your Study Protocol or Report. We return a fixed-price quote for both Standard and Expedited timelines within 24 hours.
How much does SEND dataset generation cost? +
PointCross is the lowest-cost SEND provider in the industry. Single Track Processing generates the Study Report and SEND dataset from one single data source, which can cut SEND costs by up to 50%. Use the AutoQuote Generator for a budgetary estimate, and your quote stays valid at the same price and turnaround for a full year.
Will the SEND dataset pass FDA validation? +
Yes. Every SEND package, Define.xml and nSDRG meets the FDA Technical Conformance Guide rules and carries a 100% no technical-rejection guarantee. PointCross has delivered more than 10,000 SEND datasets with zero FDA rejections.
What source files do you accept? +
PointCross accepts LIMS data with a Study Report in PDF, a Study Report in PDF/A only, scanned PDFs that are not PDF/A, and pages with handwritten annotations and data. A small, clearly stated charge applies only where extra digitizing work is required.
How long is my quote valid? +
Every PointCross SEND quote is valid for one full calendar year at the same price and the same turnaround time, so you can plan and budget ahead with confidence.
Do you also generate eCTD tables? +
Yes. Alongside SEND, PointCross generates eCTD tables for teams managing Module 4 submissions, removing a manual and time-intensive task from your workflow.
Not sure what to pick? Ask us.
If you are unsure which options to choose on the quote page, or you have any other question about SEND generation, send it over. A PointCross specialist will get back to you, usually within one business day.
Prefer an instant estimate? Use the AutoQuote Generator →
See what your SEND submission should cost.
Answer a few study parameters and get a free estimate in 60 seconds. Ready for a firm number? Send your protocol or report and we'll have a fixed quote back within 24 hours.
