Submission Dataset Preparation & Define.xml Vendors
Compare partners that assemble, validate and document regulatory submission datasets, including Define-XML and reviewer guides.
Related workflows
Software / Technology Platform · +3 more types
Products: Smart Data Quality, Smart Medical Coding +7 more
“Submission ready SDTM and define.xml saves significant time in manually processing data into target formats.”Source: saama.com
Also offers: Clinical Data Management, Data Integration, ETL & Interoperability, +1 more
CRO / Research Services Provider · +2 more types
Products: InStat, CoAuthor
“Development of Define.xml documentation for SDTM and ADaM datasets, including applicable study metadata and controlled terminology”Source: veristat.com
Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more
CRO / Research Services Provider · +5 more types
Products: Teklad, Target Sufficiency +1 more
“Inotiv’s expert team delivers CDISC compliant regulatory submissions SEND packages, transforming your nonclinical study data into structured, submission-ready formats.”Source: inotiv.com
Also offers: Toxicology Studies, In Vivo Pharmacology & Efficacy Models, +3 more
Software / Technology Platform · +2 more types
Products: Castor EDC, Castor CDMS +2 more
“Export packages formatted for FDA eSub, EMA, and PMDA submission requirements. Define.xml generation and dataset validation are part of the standard export workflow.”Source: castoredc.com
Also offers: Electronic Data Capture (EDC), eConsent, +2 more
CRO / Research Services Provider · +2 more types
Products: ClinQuick
“Celerion delivers top-quality, SDTM- and ADaM-compliant data packages that meet regulatory requirements for submissions across a wide range of therapeutic areas.”Source: celerion.com
Also offers: First-in-Human (Phase I) Clinical Pharmacology Support, Clinical Trial Bioanalytical & Biomarker Testing, +2 more
CRO / Research Services Provider · +5 more types
“Frontage can develop SEND datasets for your Bioanalytical and Toxicology studies from our Provantis® data capture system, and contribute reports utilizing the Submit™ software…”Source: frontagelab.com
Also offers: Bioanalysis & Biomarker Assay Services, Integrated CDMO/CMO Services, +3 more
Compare listed vendors
What this covers: Assembly, validation, and documentation of regulatory submission datasets, including Define-XML metadata and associated reviewer documentation.
| Vendor | Delivery model | Also offers | In their words |
|---|---|---|---|
| Castor | Software / Technology Platform | — | “Export packages formatted for FDA eSub, EMA, and PMDA submission requirements. Define.xml generation and dataset validation are part of the standard export…”castoredc.com · reviewed Oct 25, 2026 |
| Celerion | CRO / Research Services Provider | SDTM Dataset Programming, ADaM Dataset Programming, Tables, Listings & Figures (TLFs) | “Celerion delivers top-quality, SDTM- and ADaM-compliant data packages that meet regulatory requirements for submissions across a wide range of therapeutic…”celerion.com · reviewed Oct 12, 2026 |
| Frontage Laboratories | CRO / Research Services Provider | SDTM Dataset Programming, ADaM Dataset Programming, Tables, Listings & Figures (TLFs) | “Frontage can develop SEND datasets for your Bioanalytical and Toxicology studies from our Provantis® data capture system, and contribute reports utilizing the…”frontagelab.com · reviewed Oct 24, 2026 |
| Inotiv | CRO / Research Services Provider | — | “….xpt datasets define.xml and stylesheet nSDRG (Study Data Reviewer’s Guide)”inotiv.com · reviewed Oct 21, 2026 |
| Saama | Software / Technology Platform | SDTM Dataset Programming, ADaM Dataset Programming, Tables, Listings & Figures (TLFs) | “Submission ready SDTM and define.xml saves significant time in manually processing data into target formats.”saama.com · reviewed Oct 24, 2026 |
| Veristat | CRO / Research Services Provider | Clinical Data Standards & CDISC Consulting, SDTM Dataset Programming, ADaM Dataset Programming, Tables, Listings & Figures (TLFs) | “Development of Define.xml documentation for SDTM and ADaM datasets, including applicable study metadata and controlled terminology”veristat.com · reviewed Oct 21, 2026 |