SDTM/ADaM Packages

AdClin provides a unique expertise for the conversion of clinical data to CDISC SDTM and ADaM standards, and offers a large spectrum of CDISC-related Audit & Support Services, up to error-free comprehensive Study Data Reviewer's Guide & Analysis Data Reviewer's Guide.

Conforming to Submission Standards

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Clinical data (application dossiers) must be submitted to the FDA using standards developed by CDISC®: SDTM and ADaM. The standards enable the FDA to control, validate and integrate submitted clinical datasets into its review and analysis system. Clinical R&D stakeholders face several challenges such as:  – integrating conversion towards SDTM/ADaM models into their current processes, while maintaining productivity;  – avoiding possible information loss and/or alteration(s) during datasets transformation steps. In order to face these challenges, we bring a unique know-how along several lines of services:

CDISC® | SDTM & ADaM Packages | Study Data & Analysis Data Reviewer’s Guides
  • Data Conversion Service, with the creation and optimization of SDTM/ADaM packages.
  • Audit Service, in terms of CDISC® standard conformity requirements analysis, along with Support Service to deploy compliant clinical data collection, processing and analysis processes.

Comprehensive Data Conversion Services to SDTM/ADaM Standards

SDTM/ADaM Packages Delivery | SDRG & ADRG 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 (OpenCDISC® + AdClin), creation of comprehensive reviewer’s guides, pooling of clinical trials for integrated summary (ISS/ISE) Safety & Efficacy…

Leaflets (A4/Letter/Web Version):
Leaflets (A5/Printing House Version):
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