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