Biostatistics.pngCytel’s Biostatistics & Statistical Programming team provides integrated solutions, by blending the expertise of programming and experience of statistics. Our biostatisticians work with clients to determine methods for collecting, analyzing and presenting data while maintaining compliance with regulatory guidelines. Our programmers create customized tables, optimized for unique study designs. Solid statistical data analysis depends on careful planning and a statistician is involved throughout the lifespan of a project.

With the high cost of executing a clinical trial, it is critical to get the analysis right without reworking aspects of the original design. Our resources are configured to permit the greatest flexibility and customization for each client including options for dedicated teams, peak demand allocation, and global deployment.

Statistical Services:

Trial Design and Protocol Input

  • Power and sample size calculations
  • Statistical review of protocol and CRF
  • Statistical sections of the protocol
  • Statistical analysis plans

Randomization

  • Production of randomization schedule
  • Independent Randomization Centers (IRC)

Specialist Statistical Services

  • Statistical modeling/Exploratory analysis
  • PK/PD Modelling
  • Regulatory  Consulting and Representation

Interim Analyses

  • DMC Support and Participation
  • Acting as Independent Statistical Center
  • Production of Interim Analyses

Analysis, Reporting, and Publications

  • ISS/ISE Planning, Analyses and e- submission
  • Patient Profiles and ad-hoc reports
  • Statistical Reports (CSR, Manuscripts, IB)
  • Development of CDISC compliant outputs
  • TLF creation, In-text table and appendix
The work you delivered to Flexion last week was of the highest quality. Thank you very much. It is truly a pleasure to work with a team of professionals who take pride in their work in the statistical sciences."
James R. Johnson, PhD
Sr. Director Biostatistics and Data Sciences
Flexion Therapeutics, Inc.

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Trial Randomization:

Errors can risk patient drop-outs and undermine the statistical validity

Cytel has trained a dedicated team of statisticians and programmers to design randomization plans and control their implementation with zero tolerance for errors.

FlexRandomizer