Bet 3 · Native CDISC · Submission ready
Regulatory submission
wrldOS captures every form field directly into its SDTM domain. There is no end-of-study mapping project. Submission pack generation runs in seconds, not weeks. Pinnacle 21 validation runs continuously — issues surface at write-time, not at submission.
SDTM domains
8
all native at write-time
Total rows
15,097
across all domains
Pinnacle 21 errors
0
submission-clean
CDISC compliance
99.5%
12 non-blocking warnings
ATLAS-204 · ready for submission
All 8 SDTM domains validated. define-xml complete. Generate the eCTD-ready submission package now and download as a single archive.
SDTM datasets
All domains generated continuously as data is captured · validated against CDISC SDTM IG v3.4
| Domain | Description | Rows | Vars | define.xml | Pinnacle 21 | CDISC |
|---|---|---|---|---|---|---|
DM Demographics | Subject-level demographic info (age, sex, race, study arm) | 247 | 22 | ✓ COMPLETE | 0 errors · 1w | 99.6% |
VS Vital Signs | BP, HR, temperature, weight, height across all visits | 1,842 | 18 | ✓ COMPLETE | 0 errors | 100.0% |
LB Laboratory | All lab results — CBC, CMP, HbA1c, lipid, urinalysis | 8,214 | 28 | ✓ COMPLETE | 0 errors · 3w | 99.4% |
AE Adverse Events | All AEs with severity, causality, action, MedDRA coding | 412 | 26 | ✓ COMPLETE | 0 errors · 2w | 99.5% |
CM Concomitant Medications | All ConMeds with WHO Drug coding, indication, ATC class | 1,108 | 19 | ✓ COMPLETE | 0 errors · 1w | 99.7% |
EX Exposure | Investigational product administration records | 1,638 | 16 | ✓ COMPLETE | 0 errors | 100.0% |
DS Disposition | Subject disposition events (screen failure, completed, withdrew) | 247 | 14 | ✓ COMPLETE | 0 errors | 100.0% |
MH Medical History | Subject medical history captured at screening | 1,389 | 17 | IN PROGRESS | 0 errors · 5w | 97.8% |
Why this matters
On legacy EDC platforms (Veeva, Medidata, Oracle) the data is not natively CDISC. End of study, sponsors run a multi-week mapping project — CDISC programmers transforming the captured data into SDTM datasets and a valid define.xml before FDA submission. wrldOS removes that step. Datasets are SDTM at write-time, define.xml is generated continuously, and the submission package is ready the moment the last query closes.