Statistical Support for all phases of Clinical Trials

B2S provides statistical consulting and programming support in all phases of clinical trials (Phase 1 through Phase 4). 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.

B2S Consulting 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 & reviewing statistical analysis plans.
  • Creating / Reviewing / Participating in interim analysis & assessment committees.
  • Prepare materials for interim analysis & assessment committees.
  • Prepare analyses for final report, manuscript and presentation.
  • Multi-site clinical trials.
  • Safety analyses including laboratory measures, EGC and AE measurements.
  • Close work with the clinical scientist and the team to provide clinical information in a timely fashion.
  • Close work with data management, medical writers and the statistical analysts obtain high quality data and results from the clinical trial.
  • Define database, variables, help perform database quality review and help define the process for data lock.
  • Performance of meta analysis by combining data from multiple studies.
  • Defend the protocol at protocol review committees and before the FDA or other regulatory agencies.
  • Validation of al analyses and programs.
B2S Life Sciences