Services
CDISC SDTM and ADaM
Statistical Analysis
Statistical Analysis
- We can help you design an optimized CRF to collect clinical data in accordance with CDASH standards.
- Help develop robust edit check programming to identify data issues.
- Develop mapping specifications and provide programming support to convert the raw clinical data into SDTM Tabulations.
- Develop mapping specifications and provide programming support to convert SDTM data into ADaM Datasets as per the statistical analysis.
- Prepare electronic submission components: define.xml, Pinnacle 21 Compliance checks, ADRG, ARPs etc.
Statistical Analysis
Statistical Analysis
Statistical Analysis
- Perform statistical analysis on ADaM data to provide clinical summary reports.
- Develop the Tables, Listings and Figures (TLFs) for the CSR.
- Provide options for optimized and standardized TLF Shells.
- Prepare ideal responses for agency rapid response or supplemental information requests.
- Programming support for several ad hoc reports and exploratory analysis.
Customized Reporting
Global E-Submissions Support
Global E-Submissions Support
- Provide customization for statistical reports.
- Improve your company's standard reporting formats.
- Develop customized templates for specific reports for patient profiles, narratives etc.
- Generate customized reporting for ISS and ISE reporting.
Global E-Submissions Support
Global E-Submissions Support
Global E-Submissions Support
- Provide guidance and support to prepare several submission components and documentation for global regulatory submissions for
- US FDA (including RTOR, Project Orbis)
- Europe EMA
- Japan PMDA
- China NMPA/CDE
- Health Canada
- Australian Therapeutic Goods Administration (TGA)
- Swiss Medic