CDISC
In accordance with US FDA standards, we prepare the CDISC Submission Package for you.
CDASH - Operational Database (ODS)
After database closure, the data is stored in an operational database agreed with the customer. Structure and variable designations are based on international standards.
Tabulations (SDTM)
Our experienced programmers develop the SAS programs which converts the Operational Database
to the SDTM Database and test them on dummy data.
The annotated (e)CRF (acrf) and the Clinical Study Data Reviewer's Guide (csdrg) are
prepared as supporting documents.
Analysis Datasets (ADaM)
A SAS program will be developed which converts the SDTM Database to ADaM Datasets and is
again tested by using dummy data.
The Analysis Data Reviewers Guide (adrg) is prepared as a supporting document.
Tables, Listings, Figures (TLF)
The SAS programming of the tables, listings and figures is carried out, all in accordance with the SAP.
Specific validation
According to validation plans, prepared for your project, SDTM Database, ADaM Datasets, as well as the tables, listings and figures, are validated. The validation process includes, among other things, 4-eyes programming, metadata and dataset validation using the Pinnacle 21 validator and parallel programming for statistical tables, listings and figures.
CDISC Submission Package
After successful validation, the CDISC Submission Package will be assembled for you. You will receive:
- SDTM Datasets in SAS transport v5 Files, define.xml (metadata for SDTM), acrf.pdf, csdrg.pdf
- ADaM datasets in SAS transport v5 files, define.xml (metadata for ADaM), adrg.pdf, tables, listings and figures and optional SAS programs for generation of the datasets, tables, listings and figures.