DXC's Biometrics and CDISC capabilities span the total life cycle of clinical data-conversion services, including the Study Data Tabulation Model, Analysis Data Model, and Standard for Exchange of Nonclinical Data.
Life sciences and pharmaceutical companies face daunting challenges when navigating the complex regulatory review process to get new drugs approved. But, there is an easier approach.
DXC's Biometrics and CDISC (Clinical Data Interchange Standards Consortium) capabilities span the total life cycle of clinical data-conversion services, including the Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM) and Standard for Exchange of Nonclinical Data (SEND). DXC has strong operating procedures in all of its data service offerings, and we offer CDISC data mapping services for both SDTM and ADaM, define.xml and Case Report Form (CRF) annotations, as well as provide statistical programming and biometrics support.
The functional responsibilities provided by CDISC services include validation of external and internal CDISC packages, internal automated and manual quality control tools and methodologies, and expertise with Pinnacle 21 Community data fitness-assessment software. This approach allows DXC to provide standardized and up-to-date deliverables that meet regulatory requirements.
- Regulatory Experience
- Data Standardization
- End-to-End Data Conversion
- Tailored Mapping
- Regulatory Awareness
- Statistical Programming
- Statistical Analysis
- Regulatory Consulting