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Our Clinical Data Management Services include:
SGS’s Data Management team has extensive experience in setting up the eCRF application in two major EDC systems: InForm™ and Rave® for Phase I to post-marketing trials. You can rely on our expertise in the creation of validation documents for User Acceptance Testing (UAT) and our dedicated pool of UAT testers. Upon request, our eCRF designers also provide training on the EDC system for trial site, monitor and sponsor users.
SGS has adopted a proactive strategy in applying the CDISC standards to clinical trials. We developed our first Implementation Guide for SDTM already in 2005, built up a CDASH based eLibrary and are able to deliver SDTM datasets at database lock. Since then, SGS has delivered more than 150 trials in the SDTM structure at database lock, and converted more than 230 trials to the SDTM structure for submission to the FDA.
SGS is one of only a few providers worldwide selected as a CDISC Registered Solution Provider approved for SDTM, Define.xml, and ADaM.
The Data Management department uses a fully validated data management software package for data entry with electronic audit trailing, validated checks, and auto-encoding.