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