The SGS biometrics group is a European leader with over 35 years experience.
SGS has used the SDTM structure for many years, and all trials are processed using CDISC standards. This complete CDISC compliance results in efficiency, time saving, process improvement, reduced time for regulatory submissions, and better communication among team members without delays in reporting final data.
A metadata driven approach, and the seamless integration of processes and people, are key to creating clinical databases that are compliant and consistent with CDISC SDTM standards. The implementation of a metadata repository (MDR) is the first step toward a metadata driven approach; we at SGS went a few steps beyond this and built in-house tools that are linked to the MDR to achieve end-to-end automation of the SDTM workflow. The extent to which the MDR driven tools have contributed to the end-to-end automation and optimization of the SDTM workflow will be discussed.
- MDR - metadata repository
- MDR driven tools
- Anotation tool
- SDTM mapping tool
- Metadata center
The webinar is aimed at clinical data specialists such as biostatistical prorammers, clinical data managers and programmers, biometrics directors and CDISC experts.
Roman Radelicki - SGS Team Manager Data Programming