Regulatory agencies worldwide require standardized clinical data submissions. Clinovalife specializes in end-to-end CDISC standards implementation, ensuring seamless alignment from data collection through statistical analysis and submission. We provide structured, metadata-driven, and regulator-compliant solutions aligned with FDA, EMA, PMDA, and global health authority expectations.
CDASH (Clinical Data Acquisition Standards Harmonization)
Standardized Data Collection at Source
CRF Design & Optimization
- CDASH-aligned CRF development
- Standardized question text and variable naming
- Controlled terminology alignment
- Cross-study CRF harmonization
Metadata Library Development
- Creation of reusable CRF libraries
- Standard field definitions
- Data type and format standardization
- Governance for standards maintenance
Study Build Integration
- CDASH integration into EDC platforms
- Cross-functional alignment with Data Management
- Minimization of downstream transformation complexity
Value Delivered – CDASH
- Reduced downstream mapping effort
- Improved data consistency
- Faster database build cycles
- Regulatory-aligned data collection
SDTM (Study Data Tabulation Model)
Regulatory-Compliant Tabulation Datasets
SDTM Mapping & Conversion
- Mapping specifications development
- Raw-to-SDTM transformation logic
- Domain-level implementation
- Controlled terminology implementation
Custom & Complex Domain Handling
- Special purpose domain implementation
- Supplemental qualifier management
- Cross-domain consistency validation
Validation & Compliance
- Pinnacle 21 validation
- Issue remediation and resolution
- SDTM Reviewer’s Guide (sDRG) preparation
- Regulatory readiness documentation
Legacy Study Conversion
- Non-standard dataset conversion to SDTM
- Cross-study harmonization
- Program-level data standardization
Value Delivered – SDTM
- Submission-ready SDTM datasets
- Reduced Regulatory Review Cycles
- Clear traceability from source to tabulation
- Global health authority compliance
ADaM (Analysis Data Model)
Analysis-Ready & Traceable Datasets
ADaM Dataset Development
- Subject-level datasets (ADSL)
- Efficacy analysis datasets
- Safety analysis datasets
- Time-to-event datasets
Derivation & Traceability
- Derived variable specifications
- Traceability from SDTM to ADaM
- Analysis flags and population definitions
- Visit windowing and imputation strategies
Regulatory Submission Support
- Define-XML generation
- Analysis Data Reviewer’s Guide (aDRG)
- Alignment with Statistical Analysis Plan
- Submission validation support
Value Delivered – ADaM
- Transparent and traceable analysis datasets
- Efficient statistical programming workflows
- Reduced regulatory queries
- Fully submission-compliant packages
Metadata-Driven Standards Governance
- Enterprise standards library development
- Controlled terminology management
- Study-to-study consistency frameworks
- Metadata-driven transformation workflows
- Standards impact assessment
End-to-End CDISC Lifecycle Integration
- CDASH to SDTM to ADaM seamless integration
- Full traceability across datasets
- Risk-based validation approach
- Inspection readiness support
- Accelerated time to submission