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Within our documents biostatistical issues are clearly identified as an integral part of the design and conduct of clinical trials. Biostatistical principles underlie the multi-disciplinary approach necessary to ensure that clinical trials provide adequate evidence to support the decisions which rest upon them.

A – Pharma experienced statisticians use their best knowledge to provide you with following services:

  • Randomization schedules, treatment kit lists, blind break documents, and masking plans
  • Statistical plans, Randomization plans, statistical interpretation and reporting
  • Protocol and CRF development
  • Customized tables, figures, and listings for Phase I-IV clinical trials
  • Analysis planning
  • Output generation
  • Data interpretation
  • Interim analysis (futility, sample size re-estimation, efficacy, endpoint reviews) and safety updates
  • Supportive analyses for publications, manuscripts, scientific presentations, abstracts, etc.