Data Standards Implementation

Comprehensive Clinical Data Conversion Services to SDTM ADaM Standards

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Implementing CDISC Data Standards is our industry’s best practice and is also an FDA requirement for NDAs, BLAs and DMFs. Data standardization enables information system interoperability and provides a consistent general framework for organizing study data in order to create regulatory submissions that are easily interpreted, understood, and navigated by regulatory authorities. Data standardization thus improves the overall quality of data and efficiency of review.

As certified CDISC Registered Solutions Provider we provide professional expertise for the conversion of clinical data to CDISC SDTM ADaM standards. IDDI makes sure your data are ready for submission.

  • All pivotal studies conducted by IDDI are performed in compliance with FDA and CDISC requirements. To reach this goal, IDDI transforms the database structure into an SDTM structure associated with the appropriate documentation. Our EDC is compliant with ODM standards.
  • Our SDTM/ADaM experts have the ability and experience in developing eCRFs to CDASH standards and delivering data in SDTM and ADaM format.
  • SDTM/ADaM datasets are generated using the latest CDISC model in production at the start of the process.
  • IDDI has the experience and capabilities of performing quality control/verification of existing packages to ensure they are ready for submission.

SDTM ADaM Package

  • Mapping to SDTM ADaM standards
  • Annotated CRFs
  • .xpt file generation
  • xml and define.pdf file creation from SDTM/ADaM dataset definitions
  • Validation of data and define files (Pinnacle21-Community, formerly OpenCDISC)SDTM ADaM Standards
  • Creation of comprehensive reviewer’s guides
  • Pooling of clinical trials for integrated (ISS/ISE) Safety & Efficacy summaries

SDTM:

  • SDTM programming is done using SAS 9.3
    • SDTM programming template
    • SDTM formatting work is highly automated (SUPP– generation,  variable ordering and labelling, ISO 8601 (partial) dates conversion, …)
    • Pinnacle21-Community (formerly OpenCDISC Validator is used to verify SDTM compliancy
  • QC is done by comparing eCRF print-outs vs SDTM tables using dummy data to ensure different scenarios are covered
  • External data integration/reconciliation + Dictionary coding integration handled via SAS as well (via odbc, or snapshot files)
  • EPOCH, –BLFL: handled via study-specific algorithms

IDDI SDTM Experience:

  • 2013-2017: Over 20 Studies in SDTM during the last 5 years
  • Latest version of SDTM IG used
  • xml/Define.pdf creation
  • Development of client-specific CRF and SDTM standards
  • Our main expert has over 8 years of experience in CDISC, is specialized in SDTM and Define.xml, and presented at CDISC UK Network F2F in 2015, CDISC Europe Interchange 2013

ADaM

  • Production of ADaM Datasets
    • Dataset specification file created (including metadata) using IDDI template
    • Programmed using latest SAS version, current ADaM Model and ADaM IG
    • CDISC compliance checked with Pinnacle-21 Community (formerly OpenCDISC Validator)

IDDI ADaM Experience:

  • 2013-2017: Over 10 Studies in ADaM during the last 5 years

IDDI is a CDISC Associate Member.