Statistical Services

WebbWrites can provide an experienced statistical partner for your clinical development team.

We offer a full range of statistical consulting services, including:

  • Protocol development and review
  • Sample size estimation
  • Statistical analysis plan development and review
  • Review of draft tables, listings, and figures from the Sponsor’s┬áprogramming provider
  • Exploratory analyses
  • Clinical study report and summary document development and review
  • Support (preparation and attendance) for regulatory meetings (eg, End-of-Phase 2, pre-submission, advisory committee, special protocol assessment)
  • Support meetings with upper management and key opinion leaders
  • 1/2- to 3-day classes on basic statistical concepts for clinical research

STATISTICS PROFESSIONALS COMMITTED TO RIGOROUS CLINICAL SCIENCE

Experience

Approximately 30 years of experience, evenly divided between pharma and CRO-based companies. Attendance at more than 75 regulatory meetings (US and Europe) across >10 therapeutic areas, with extensive experience participating in FDA advisory committee meetings. More than 12 years of clinical writing experience (eg, regulatory briefing books, CSRs, and overviews).

Synergy

Getting early statistical input can expedite time from database lock to submission. Regular participation in team discussions promotes innovative, practical solutions to statistical problems.

Process

You will be assigned a specific statistician whose work will be billed on an hourly basis for work performed. Contracts can be tailored for your specific needs.