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What You'll 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 
  • Enabling technology

Presented by:

Ron Marks, PhD
Chief Scientific Officer, Director of Biostatistics, Co-Founder, Clinipace Worldwide
Ron is a biostatistician and biomedical researcher, having served on the University of Florida faculty for 30 years in the Division of Biostatistics before joining Clinipace in 2004. He 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
As a biostatistician with Clinipace, 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. 

Free Webcast:

Navigating Regulatory Biostatistical Requirements Throughout the Clinical Trial Lifecycle

Download the webcast now!