Biostatistics and Statistical Programming

Statistical skills and experience. Precise analyses.

PharmaNet/i3 Strategic Resourcing biostatisticians have a broad knowledge base in all aspects of clinical trials, from the initial stage of planning the design and calculating sample size requirements, to analyzing, displaying and interpreting data in the final stages of the study. In addition, our biostatistics team has significant experience preparing analyses for regulatory submissions in a manner that facilitates their review. PharmaNet/i3 Strategic Resourcing experts plan the analyses you’ll need before the study begins, then provide reports, statistical summaries, and efficacy and safety analyses promptly and accurately as the study progresses.

We can leverage our vast statistical experience to design studies in a way that speeds submissions. Our thorough validation and quality control processes will eliminate the need for corrections and ensure accurate results. By applying standard templates and programs with customization as needed, we will provide efficient, high quality analyses for your project.

Biostatistics services include:

  • Protocol development, including sample size and power calculations
  • Randomization schedules
  • Statistical analysis plans
  • Statistical programming in SAS®
  • Statistical analyses using current methodologies
  • Interpretation and reporting of data for clinical trial reports and publications
  • Statistical and strategic consulting for product development
  • Interim analysis for early decision-making
  • Database integration
  • Adaptive design consulting and simulation support
  • Data monitoring board management and support
  • NDA-ready data listings
  • CDISC-compliant datasets
  • Integrated safety and efficacy summaries

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how we can help you