Examination of Clinical Trial Costs and Barriers for Drug Development. 2.1 Data Sources


In constructing an operational model of clinical trial decision-making, we compiled information from a variety of sources, including:

  • Publically available literature;
  • Interviews with experts, FDA personnel, drug sponsors, clinical research organizations (CROs) as well as major academic clinical research centers;
  • April 2012 FDA public hearing on the subject of Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice;
  • Medidata Solutions databases;
    • Medidata Grants Manager® (PICAS® )
    • Medidata CRO Contractor® (CROCAS® )
    • Medidata Insights

More information on the above data sources are provided below

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