Biometrics & Statistical Sciences
CDISC SDTM and ADaM
Standards-compliant datasets and documentation, prepared for regulatory eSubmissions. Our CDISC SDTM and ADaM work covers data mapping, analysis datasets and the documents that accompany them.
Overview
We map study data to SDTM, develop ADaM analysis datasets and prepare the supporting documentation (Define.xml, cSDRG and ADRG) with submission compliance in view from the start.
Our regulatory eSubmissions support covers NDA, BLA, MAA and IND submissions, with FDA and EMA submission support.
What we do
SDTM mapping, ADaM development, Define.xml, cSDRG and ADRG, with regulatory eSubmissions support.
CDISC deliverables
- SDTM Mapping
- ADaM Development
- Define.xml
- cSDRG
- ADRG
- Submission compliance
Regulatory eSubmissions
- NDA
- BLA
- MAA
- IND
- FDA Submission Support
- EMA Submission Support
Frequently asked questions
What is CDISC SDTM?
The Study Data Tabulation Model, a standard structure that organizes collected trial data into defined domains such as demographics and adverse events.
What is the difference between SDTM and ADaM?
SDTM holds data as collected. ADaM holds analysis-ready datasets derived from SDTM, with derived variables, analysis flags and traceability back to SDTM.
What is define.xml?
The machine-readable metadata file describing the datasets, variables, controlled terminology and derivations in an SDTM or ADaM submission.
Which regulatory submission types do you support?
We support NDA, BLA, MAA and IND submissions, with FDA and EMA submission support.
Do you prepare cSDRG and ADRG reviewer guides?
Yes. We prepare the cSDRG for SDTM data and the ADRG for ADaM data, alongside Define.xml.
Contact our team
Share your study, submission or evidence need and we will come back to you on scope and next steps for CDISC SDTM & ADaM.
Start with what you need