FMD K&L understands the value of standardized study data pertaining to Clinical Data Interchange Standards Consortium (CDISC) specifications. We are a proud CDISC Registered Solutions Provider and have been involved in CDISC standards since 2002. Our data management team builds clinical databases using CDASH standards and advanced EDC technology to minimize the gap between raw data and SDTM during the transformation process. Our dedicated SDTM team draws from rich SDTM mapping experience to support current and legacy clinical data submission packages (SDTM aCRF.pdf, SDTM xpt, define.xml, and SDTM Reviewer’s Guide) to the FDA. Our statistical programming team follows the ADaM Implementation Guide to create ADaM datasets and subsequently tables, listings, and figures supporting clinical and medical writing needs. By skillfully employing CDISC standards and staying current with FDA submission guidance, FMD K&L expedites implementation of these standards promoting efficient agency review.

Our CDISC implementation and eSubmission services include, but are not limited to, the following:

Process improvement and CDISC SDTM/ADaM implementation consulting

  • Develop company standards based on CDISC current models
  • Optimize data flow from data capture CDASH to SDTM to ADaM to TLFs
  • Optimize clinical tool sets to achieve standards and return on investment
  • Knowledge transfer of data standardization process
  • Study data standardization plan (SDSP)

Legacy / ongoing study data conversions to SDTM standards

  • SDTM annotated CRF (aCRF.pdf)
  • SDTM mapping specifications
  • Conversion of legacy raw datasets to SDTM datasets
  • SDTM define.xml
  • SDTM compliance checks using OpenCDISC / Pinnacle 21 Validator
  • SDTM Reviewer’s Guide (SDRG)

ADaM standards

  • ADaM specifications
  • Creation of ADaM datasets
  • ADaM define.xml
  • ADaM compliance checks using OpenCDISC / Pinnacle 21 Validator
  • ADaM reviewer’s guide (ADRG)