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CDISC data standardisation

Getting ready for successful submissions

Regulation mandates that studies initiated on or after December 2016 must have standardised data, and the PMDA requires CDISC standardisation of study data for all submissions after April 1, 2020.

Converting all legacy studies in a program may not be necessary but proactively reviewing studies, preparing your legacy data into SDTM submission packages and confirming primary analyses in advance could avoid associated delays in getting your product to market, when time is critical.

ICON provides an agile, best practice solution that includes advice on compliance, selecting the right studies for legacy conversion and efficient end-to-end delivery that could reduce time and costs in your overall study. Our CDISC standardisation specialists have the experience and expertise for a smooth conversion.

SDTM experience

  • <650

    Studies and over 13,000 SDTM compliant domains

  • 50+

    SDTM managers, leads and programmers

  • 122

    Studies and 2,425 SDTM packages

ADaM experience

  • 170+

    Specially trained programmers

  • 50+

    Sponsors have used our services

  • 125

    Studies and 2395 datasets

CDISC service offerings

SDTM & ADaM Creation - adaptable to client requirements

  • Legacy data conversion
  • Compliance checks using Pinnacle 21 enterprise or community and in-house tools
  • Study data harmonisation including coding dictionary up-versioning
  • CSR gap analysis: verification of CDISC conversion by reproducing and comparing analysis produced using CDISC converted data
  • e-Submission package
    • Electronic Common Technical Document (eCTD) Module 5, including SDTM define.xml, SDRG, ADaM define.xml including ARM, ADRG.
    • Post submission support (rapid response)
  • Rescue studies
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