Clinical Trial Statistics
B2S Life Sciences® provides statistical consulting and programming support from Phase 1 through Phase 4 of clinical trials. Our staff has many years of both statistical and programming experience within clinical trials working with major pharmaceutical companies.
We are prepared to help our clients in all phases of clinical trial research, from the initial planning and study design, protocol development, statistical analysis plan, interim analyses, final analysis and report, statistical support for manuscripts and presentations and statistical defense and interactions with regulatory agencies in the US and abroad.
We help prepare clinical data for analysis by working alongside with data management, other CROs, outside laboratories. A close collaboration with the clinical scientist, data management and medical writers allows us to generate high quality data and results, providing clinical information in a timely fashion.
B2S Life Sciences® provides experienced statistical support in all phases of clinical trials including:
Protocol study design
Sample size and power calculations
Statistics section of the protocol
Creating and reviewing statistical analysis plans
Creating, reviewing and participating in interim analysis and assessment committees
Preparing materials for interim analysis and assessment committees
Preparing analyses for final report, manuscript and presentation
Multi-site clinical trials
Safety analyses including laboratory measures, EGC and AE measurements
Performance of meta-analysis by combining data from multiple studies
Defending protocol at protocol review committees and before the FDA or other regulatory agencies
Validation of all analyses and programs
Creating analysis datasets to be used in analysis, listings, tables and graphs
Providing listings, summaries and graphs for the final study report, manuscript or presentation, interim analysis or periodic safety reports
Providing ongoing support for special listings or summaries requested by the clinical team or the clinical scientist