SDTM/ADaM Audits

Being fully compliant with the latest CDISC standards enables the FDA to control, validate and integrate submitted clinical datasets into its review and analysis system. In order to face these challenges, we bring a unique expertise in terms of auditing SDTM/ADaM Packages.

Conforming to Submission Standards

Clinical026

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 streamline your operations, we offer SDTM/ADaM auditing value-added services.

Comprehensive Audit Services of SDTM/ADaM Packages

  • By analyzing defects and inconsistencies in the various packages that you might have elaborated and/or in the packages that you have been provided with by a third-party. Upon execution, the relevant SDTM/ADaM audit report(s) will delineate issues and lay down recommendations.
  • By analyzing gaps and weaknesses between your current processes and those that you may deploy to comply with the relevant operational CDISC® and FDA requirements.
  • By providing different solutions and/or options that will enable your organization to achieve and to maintain over time a full operational compliance to these CDISC® and FDA requirements.
Leaflets (A4/Letter/Web Version):
Leaflets (A5/Printing House Version):
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