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Free eBook:

Navigating Regulatory Biostatistical Requirements Throughout the Trial Lifecycle

Regulatory authorities aim to assure the safety and efficacy of drugs, biological products and medical devices by overseeing all aspects of a clinical trial lifecycle. Are you working with a partner with the expertise and technological resources to assist with this process and help the process go as smoothly as possible?

Download this eBook to learn:

  • Common statistical issues (during trial planning, conduct, analysis and submission phases)
  • Case study examples of common issues
  • Recommended approach to address common issues to regulatory authority's satisfaction
  • How enabling technology will increase your odds of success
Authors:
Ron Marks, PhD
Chief Scientific Officer, Director of Biostatistics, Co-Founder, Clinipace Worldwide
Ron has an extensive background in design, analysis and reporting of large-scale clinical trials and other research studies, and has been a lead clinical trial consultant with a number of large pharmaceutical companies including Unilever, Braun, Procter & Gamble and GSK.

Scott Miller, PhD
Biostatistician, Clinipace Worldwide
Scott works on trials ranging from Phase 1 to 4, providing statistical input into clinical trial protocols and eCRFs, writing statistical analysis plans and TFL shells, implementing statistical analyses, and interacting with the FDA in protocol submission meetings or response letters. 

Download the eBook now:

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