CDISC Implementation
& mapping
CDISC data standards are highly recommended by the FDA for Submission. These standards are now adopted in various phases of clinical research by industries. With our experience, we can help your company make data standards implementation and migration unified. We currently follow STDMIG 3.1.2 to STDMIG 3.1.3 and ADaMIG 1.0.
- CDISC compliant Case Report Form
- CDASH annotated Case Report Form
- SDTM annotated Case Report Form
- Trial design compliant Dataset
- SDTM compliant Dataset
- ADaM compliant Dataset
- Generation of Define.xml, rtf and pdf
- ADaM metadata
- Utilization of Open CDISC
CDISC data standards specify how to structure clinical trial data for regulatory submissions to the US Food & Drug Administration (FDA). They are widely used during the analysis, reporting and the regulatory submission of clinical data.
We specialize in CDISC implementation and data mapping services to ensure compliance with industry standards and facilitate the exchange of clinical trial data across different systems and organizations. Our expert team can help you navigate the complexities of CDISC standards and streamline your data management processes. By implementing CDISC standards and ensuring data mapping adherence, you can streamline data exchange, improve data quality, and facilitate regulatory submissions.
Contact us today to discuss how our CDISC implementation and data mapping services can optimize your data management processes.
- CDISC Standards Expertise
- CDISC Compliance Assessment
- CDISC Implementation Planning
- CDISC Data Mapping
- CDISC Metadata Management
- CDISC Compliance Documentation