Our experienced team of biostatisticians and programmers provide trial design and statistical consulting, programming expertise, and reporting to ensure that key deliverables meet the standards of quality and timeliness that our sponsors expect and require.
Our Biostatistics team has significant experience helping sponsors prepare protocols with the analyses in mind, providing final reports, and statistical summaries as well as interim efficacy and safety analyses throughout the study.
Our project teams include seasoned Biostatisticians and SAS Programmers who work together to ensure that study deliverables meet quality standards within required timelines. DP Clinical can provide full service statistical support or collaborate with your preferred Statistician to meet the requirements of your program.
DP Clinical’s biostatistics services include:
- Development of statistical input for the clinical trial design, including adaptive designs
- Sample size and statistical power analysis
- Preparation and analysis of Statistical Analysis Plan (SAP)
- Generation of randomization schedule and secure maintenance of treatment blinding
- Statistical programming and validation
- Preparation of legacy study data to FDA-required CDISC SDTM and ADaM standards with Pinnacle 21 validation and required documentation (define.xml, Reviewer’s Guides, SDTM annotated eCRF)
- Preparation of tables, listings, and figures
- Support for Safety Monitoring Committee (SMC) and Data Safety Monitoring Board (DSMB)
- Production of interim, exploratory, and meta analyses
- Preparation and review of statistical reports and summaries
- Preparation of materials/reports for annual IND and safety reviews
