Standardization of Clinical Data
MEDKINE’s team of Clinical Data Standardization Subject Matter Experts assists organizations in utilizing CDISC, SDTM, and ADaM standards for their internal operations and regulatory submissions. We support companies in effectively implementing CDISC standards, ranging from data gathering to electronic submission. Our aim is to deliver a distinctive value-added integration of technology and data standards in an efficient manner, considering both time and cost efficiency.
MEDKINE CDISC Services are
- CDISC deployment utilizing Alps-ai
- Mapping and conversion of CDISC SDTM
- CDISC ADaM coding and reporting
- Legacy data and current data are being converted to SDTM and ADaM formats
- The subsequent accomplishments are attained through the use of the Alps-ai platform
- Compliance assessment
- Mapping of CRF/eCRF to CDISC – SDTM variables
- Define.xml, the Study Data Reviewers Guide (SDRG), and the Analysis Data Reviewers Guide (ADRG) are associated with SDTM and ADaM
- SDTM Mapping and Transformation
