eSubmission / CDISC

FMD K&L understands the value of Standardized Study Data as it relates to the Clinical Data Interchange Standards Consortium (CDISC) specifications. We are proud to be a 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 in the SDTM transformation process. Additionally, we have a dedicated SDTM team with rich SDTM mapping experience to support current / legacy clinical data submission packages (SDTM aCRF.pdf, SDTM xpt, define.xml, and SDTM Reviewer’s Guide) submitted to the FDA. Our statistical programming team follows the ADaM Implementation Guide to create ADaM datasets and subsequently tables, listings, and figures to support clinical and medical writing needs. By expertly employing CDISC standards and actively working to keep up with FDA submission guidance, FMD K&L is able to expedite implementation of these standards, which promotes 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 

  • Help to develop your company's standards based on CDISC current models 
  • Optimization of data flow from data capture CDASH to SDTM to ADaM and then to TLFs 
  • Optimization of clinical tool sets to achieve the standards and return on investment 
  • Knowledge transfer of the data standardization process 

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 21Validator
  • SDTM Reviewer’s Guide (SDRG) 

ADaM Standards 

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