Our experts simplify the process of converting from SDTM/ADaM to NDA electronic submission, standardize data goals, ensure consistency of attributes for each variable between data sets, define files and programming specifications, and avoid wasting time and resources to verify late consistency.
The programming specification document is a key part of the SDTM conversion process because of its programming and verification capabilities, writing definition PDFs, and defining the generation of the main parts of the XML. There is a great need for a cost-effective way to ensure SDTM conversion meets the requirements described in the SDTM Implementation Guide and internal standards, and to ensure consistency between SDTM data sets, programming specifications, and definition files.
Our SDTM services cover a range of clinical and non-clinical experimental variables with programming specifications and define files. Consistency among them is guaranteed. It prevents the waste of resources due to consistency checking. If there are some changes in the SDTM dataset at any stage, we can update the data in the SDTM.