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Biostatistics

Clinical Trial Biostatistics and Analysis

Reducing risks and costs, while accelerating timelines and results

Clinical Development Plans with a Program-wide View

In the planning stages, WCCT’s biostatistics consultants focus on your clinical development plans to provide you with a program-wide view. Leveraging its wealth of experience, the team can help you achieve these benefits:

  • Accelerated timelines and faster results via adaptation of novel designs (e.g., adaptive trials, Bayesian decision-making, etc.)
  • Greater savings
  • Reduced risks
  • Improved quality of submissions
Our service offerings include:
  • Discussion with regulatory agencies, including study design/analysis questions from regulatory agencies worldwide
  • Study design assistance during protocol development, including study objectives clarification
  • SAS programming and analysis
  • Sample-size/power calculation to increase likelihood of meeting objective within regulatory framework
  • Preparation of statistical analysis plan (SAP) to detail the statistical methodology and analytical plans
  • CDISC-compliant datasets (e.g., SDTM and AdaM)
  • Generation of statistical outputs for CSRs, DMCs and periodic safety documents
  • Results and methodology sections of the clinical study report
  • Integrated documents for submission

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