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10-Step Commercial Clinical Protocol Authoring Guide

maze-table.jpgA protocol is the most important document in a clinical study as it is the foundation for subsequent operational, regulatory, and marketing objectives for the development program. Developing a protocol is an extensive undertaking that requires a cross-functional team and consideration of the position and role of the study in the full product development program.  This guide includes information on:

  • Designing the study
  • Drafting the synopsis
  • Minimizing the potential for amendments