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Contract Research Organizations and Monitors

  • Cara East
Chapter

Abstract

Contract research organizations, or CROs, are an integral part of clinical research. Today, there are over 1100 CROs, which are for-profit companies that serve the various research needs of pharmaceutical sponsors. The pharmaceutical industry invests as much as five times as much as the average manufacturing company does in research and development. CROs allow the industry to outsource many of the steps of the clinical research process. The CRO is responsible for the budget, the contract, and the monitoring of the study data. As such, the site needs to have a plan to optimally handle study monitors and minimize their interruption of ongoing study activities, which may include feeding back to study managers when necessary.

Keywords

Contract research organization (CRO) International conference on harmonization Kefauver Harris amendment Monitor Certified research associate Electronic medical record Study manager 

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Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Cara East
    • 1
  1. 1.Baylor Soltero CV ResearchBaylor University Medical CenterDallasUSA

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