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
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Help to develop your company's standards based on CDISC current models
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Optimization of data flow from data capture CDASH to SDTM to ADaM and then to TLFs
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Optimization of clinical tool sets to achieve the standards and return on investment
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Knowledge transfer of the data standardization process
Legacy / Ongoing Study Data Conversions to SDTM Standards
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SDTM annotated CRF (aCRF.pdf)
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SDTM mapping specifications
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Conversion of legacy raw datasets to SDTM datasets
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SDTM define.xml
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SDTM compliance checks using OpenCDISC / Pinnacle 21Validator
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SDTM Reviewer’s Guide (SDRG)
ADaM Standards
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ADaM specifications
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Creation of ADaM datasets
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ADaM define.xml
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ADaM compliance checks using OpenCDISC / Pinnacle 21Validator
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ADaM Reviewer’s Guide (ADRG)