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Clinical Research Organizations

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Book cover Pediatric Cancer Therapeutics Development

Part of the book series: Pediatric Oncology ((PEDIATRICO))

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Abstract

Contract research organizations, also known as clinical research organizations (CROs) or contract service organizations (CSO), or pharmaceutical development organizations, are established businesses that collaborate with pharmaceutical or medical device companies to assist them in the clinical development of their medication or device. While the sponsor retains responsibility for the conduct of the trial, CROs provide essential support services that may include regulatory affairs, regulatory submissions, budget generation, data management, biostatistics, medical monitoring, clinical monitoring, medical writing, and project management. CROs facilitate drug and medical device development by operationalizing clinical trials in accordance with Good Clinical Practice (GCP) guidelines, relying on their expertise in clinical trial conduct, operations experience, and close relationships with sites and investigators.

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Author information

Authors and Affiliations

  1. Medpace, Inc., Cincinnati, OH, USA

    Gregory A. Hale

  2. Clinical Trial Management, Medpace, Inc., Cincinnati, OH, USA

    Jennifer Pullum

Authors
  1. Gregory A. Hale
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  2. Jennifer Pullum
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Correspondence to Gregory A. Hale .

Editor information

Editors and Affiliations

  1. Clinical Development, Kronos Bio, San Mateo, CA, USA

    Jorge DiMartino

  2. Department of Pediatrics, George Washington University, Washington, DC, USA

    Gregory H. Reaman

  3. Medpace, Cincinnati, OH, USA

    Franklin O. Smith

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Hale, G.A., Pullum, J. (2022). Clinical Research Organizations. In: DiMartino, J., Reaman, G.H., Smith, F.O. (eds) Pediatric Cancer Therapeutics Development. Pediatric Oncology. Springer, Cham. https://doi.org/10.1007/978-3-031-06357-2_8

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  • DOI: https://doi.org/10.1007/978-3-031-06357-2_8

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  • Print ISBN: 978-3-031-06356-5

  • Online ISBN: 978-3-031-06357-2

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