01
Source / EDC
STATISTICAL PROGRAMMING & CDISC
Statistical Programming & CDISC Services
SAS and R programming for clinical trials, with traceable CDISC implementation from source data through submission-ready analysis deliverables.
TRACEABILITY
A Traceable Programming & Metadata Model
02
SDTM
03
ADaM
04
TFLs
Submission documentation & metadata layer
SDTM specificationsSDTM Define-XMLADaM specificationsADaM Define-XMLSDRG / ADRGIssue documentation
DELIVERABLES
What We Deliver
SDTM
aCRF, specifications, dataset programming, controlled terminology and validation.
ADaM
Analysis specifications, derivations, traceability and validation.
Tables, Figures & Listings
Production and validation programming aligned with SAP and shells.
Define-XML
Machine-readable metadata describing datasets, variables, origins, codelists, value-level metadata and derivations for SDTM and ADaM packages.
Reviewer Guides
SDRG and ADRG development, including study-specific explanations and issue documentation.
SAS & R
Programming according to study, client and validation requirements.
QUALITY
QC & Validation
Independent QC / Validation Programming
Independent programming or targeted verification for selected high-risk derivations, datasets and outputs.
Pinnacle 21 Conformance Review
CDISC conformance review with findings assessment, documentation and an agreed resolution strategy.
Cross-Deliverable Review
Programs, logs, outputs, metadata, specifications and reviewer documentation checked for consistency before release.