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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