Our CDISC Implementation & eSubmission Services
Process Improvement & 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 toolsets 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)
Extensive SDTM / ADaM Experience Since 2002
- CDISC Gold Member
- CDISC Registered Solution Provider
- Co-leader of a CDISC / FDA Data Integration Pilot
- Member of CDISC SDS Working Group
- Member of CDISC ADaM Working Group
- Member of CDISC XML-Tech Group
- Member of CDISC China Committee