• Publications
  • Influence
Getting Rid of Bloated Data in FDA Submissions
TLDR
We provide a detailed discussion of 12 high-level rules that apply to folders, transport files, and data sets; we also provide utility programs to help evaluate whether your submission complies with those rules. Expand
Creating Analysis Data Marts from SDTM Warehouses
TLDR
This paper describes a two-step approach that has been used to build SDTM warehouses and then to extract analysis data marts from them. Expand
  • 1
  • PDF
Some Strategies for Validating Your Data before Submission
TLDR
We describe some special-purpose macros that can be downloaded from SAS that can create both V5 transport files (for clinical trial submissions) as well as V8 and V9 transport files for non-submission purposes. Expand