SDTM/ADaM Packages and Study Data Reviewer’s Guide Set-Up

We can help to set, test and secure error-free comprehensive SDTM workflows – onsite or offsite – for your clinical data management and datasets processing or dossier submission operations.

SDTM/ADaM Packages Delivery | Study Data Reviewer’s Guide Delivery

Mapping to SDTM/ADaM standards, annotated CRFs, .xpt file generation from SDTM/ADaM definitions, define.xml and define.pdf file creation, validation of data and define files (Pinnacle 21® + AdClin Scripts), creation of comprehensive reviewer’s guides, pooling of clinical trials for integrated summary (ISS/ISE) Safety & Efficacy…