Symbiance’s pool of Clinical Data Standardization SME’s help companies leverage CDISC, SDTM and ADaM standard for their internal practices/processes and regulatory submission. We help companies successfully apply CDISC standards , from data collection to eSubmission. Our goal is to bring a unique value-added combination of technology and data standards together in an efficient way from both a time and cost perspective.
Symbiance CDISC Services are
- CDISC implementation using Alps-ai
- CDISC SDTM mapping and conversion
- CDISC ADaM programming and documentation
- Legacy and ongoing data conversion to SDTM and ADaM
- The following are achieved using the platform Alps-ai
- Compliance evaluation
- Annotation of CRF/eCRF to CDISC -SDTM variables
- Define.xml, Study Data Reviewers Guide (SDRG) and Analysis Data Reviewers Guide (ADRG) for SDTM and ADaM
- SDTM Mapping & conversion