Step-by-Step Guide to Safe and Effective Clinical Trials

May 2006
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This management report presents a "master plan" of clinical trial planning to help you get your drugs to market faster, ensure adherence to federal regulations and good clinical practices and keep budgets under control.

From how to engineer a clinical program to organizing a project team to handling an FDA site audit — the Guide covers every critical stage of the trial process, including:

  • The ins and outs of project teams and the benefits of a project team kickoff
  • The importance of preparing a well-written protocol
  • What to look for when selecting investigators and sites — including key metrics you can use to evaluate performance
  • How to best negotiate investigator contracts
  • What to include when collecting regulatory documents, including flow charts
  • How to track study progress, including a Gantt model, detailed list, 4 charts and graphs, and a sample budget
  • The details of clinical monitoring, with pre-study visits, initiation visits, routine monitoring and closeout visits
  • Strategies for better data management and quality
  • How to organize a statistical analysis plan
  • What to do if your site is audited by the FDA
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