CDISC SERVICES
Our CDISC Services Includes:
Biostates IT Solutions have specialized expertise to handle CDISC data standards conversions and integrations of all sizes, either for specific programs getting ready for submissions, or across entire enterprises with the defined process-based conversion approach that helps us to provide high quality, on-time deliverables.
We have a set of in-house developed and validated macros which facilitate conversion of any customer specific data structure to CDISC standard datasets for both Study Data Tabulation Model (SDTM) analysis Data Model (ADaM), with minimal work. This conversion process is well thought-out and automated and it eliminates any chance of programming errors.
- CDISC SDTM compliant datasets from any customer specific data structure
- Data conversion of legacy data to standardized data structure
- Up-versioning services
- Clinical data asset review services to support FDA submission strategy
- Implementation of crossover correction methods in SAS
- Compliance checks
- Sponsor Designed Standards Implementation
- Compliant Submission Data Packages - SDTM annotated CRF, define.xml, Reviewer's Guide
- Analysis ready ADaM domains, ADaM define.xml, Reviewer's Guide
- Validation documents and OpenCDISC Report
- SDTM and ADaM mapping specifications, programming and validation
- SDTM and ADaM transport data delivery