All About Compliance

E-SUBMISSION/CDISC

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)