Our statisticians frequently collaborate and meet with regulators in various therapeutic divisions, including standard and alternative regulatory paths such as orphan, breakthrough, and fast-track. Our team oversees timelines, handoffs, communication plans, and milestones across data vendors and all functional areas. Their work encompasses:

  • Randomization schedules, treatment kit lists, blind break documents, and masking plans
  • Customized tables, figures, and listings for Phase I-IV clinical trials
  • CDISC-compliant data packages
  • CDISC database standardization and legacy conversions
  • Analysis planning
  • Output generation
  • Data interpretation
  • Data integration and integrated summaries (ISS/ISE)
  • Interim analysis (futility, sample size re-estimation, efficacy, endpoint reviews) and safety updates
  • Supportive analyses for publications, manuscripts, scientific presentations, abstracts, etc.
  • Review of data management documents and database setup

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