Clinanalytica has an expert team of with strong technical understanding of both Study Data Tabulation Model (SDTM) analysis Data Model (ADaM), corresponding implementation and Reviewers’ guides, CDISC terminologies and the related regulations.
- Creation of related documentation: SDTM annotated CRF, SDTM metadata, DEFINE.PDF, DEFINE.XML
- Creation of documentation related to ADaM: analysis level, dataset level, variable level, parameter level documentation
- Mapping of studies from legacy to CDISC standards for ISS/ISE reporting and regulatory submissions.
Ready to help you with preparation of CRT packages, SDTM transport files, define.xml & define.pdf, and authoring of Reviewer guidesdefine