Submission-ready packaging
Datasets and documentation packaged to eCTD standards, built directly on SDTM and ADaM work already completed.
What's included
What goes into the package
- Final SDTM and ADaM datasets, packaged to eCTD standards
- define.xml built alongside the datasets it describes, not reverse-engineered before filing
- Reviewer's guides (SDRG/ADRG) anticipating the questions a reviewer is likely to ask
- Annotated CRFs (aCRF) cross-referenced to the SDTM domains they source
Reviewer-facing documentation
define.xml and reviewer's guide preparation aligned with overall submission strategy, anticipating the questions a reviewer is likely to ask.