We can meet your data analysis needs by providing statistical tables, listings and figures for input in your clinical and statistical reports.
We also have the expertise to help you develop standard SAS macros and tools to support accurate reporting of your clinical trial data.
CDISC: SDTM, ADaM & Define.xml
Our staff has received training in SDTM and ADaM from CDISC. We keep abreast of any updates from the CDISC and OpenCDISC community.
We can support you with the mapping of your current and legacy data into CDISC, Standard Data Tabulation Models (SDTM).
From SDTM we can create a reporting database using your company standards or following CDISC Analysis Data Model(ADaM).
Ad-hoc Programming & FDA Submission Support
We have experience with FDA submission and provide support with the following tasks:
- Study Data Reviewer’s Guide (SDRG) and Analysis Data Reviewer’s Guide (ADRG)
- SDTM annotation of case report forms
- Creation of define.xml and/or define.pdf
- Office of Scientific Investigation (OSI) Request