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)