Services
Scope: Biostatistics and Statistical Programming:
To provide customized planning and reporting solutions for each project, in close collaboration with the client, employing the powerful SAS statistical software, as well as other appropriate available software
Biostatistical Services
Our biostatistical services include:
- Review statistical section of protocol
- Protocol & CRF review (consistency between the two)
- Statistical input & oversight of the Report and Analysis Plan
- Interpretation of statistical results
- Summarization of statistical results
- Documentation of statistical aspects
Our statistical programming services include:
- Protocol and CRF Review
- Prepare Statistical Analysis Plans
- Prepare Analysis dataset specifications
- Generate Analysis datasets and/or ADaM datasets
- SCS/SCE (pooling) database preparation
- SCS/SCE (pooling) statistical analysis
- SAS Programming for interim and final analysis
- Interim Analysis and DMC Support
- Table, Listing, and Figure Generation
- Statistical sections of Clinical Study Report, Manuscripts, Investigator's Brochure
- Integrated Clinical/Statistical Development Programming
- PK/PD Model Development and Analysis
- Perform SAS programming Verification and Validation
- Provide all programming documentation
- Ad hoc or exploratory Programming
- SDTM and ADaM data mapping and conversion