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CRSO Services

The CRSO frequently assists industry sponsors and academic centers by identifying potential site investigators at Children's Hospital. An investigator who would like to conduct a clinical trial or who has been contacted by an industry sponsor or academic center to conduct a clinical trial should contact the CRSO for assistance.

The CRSO supports projects funded by a variety of sources, including but not limited to National Institutes of Health, industry sponsors, foundations, organizations, and research networks.

The CRSO is available to:

  • Assign experienced clinical research staff to work collaboratively with principal investigators and study teams to initiate and facilitate quality research
    • Study coordinators are available on a full-time, part-time, or fee-for-service basis.
    • Clinical project managers and clinical research associates (monitors) are also available.
  • Facilitate study feasibility and study placement decisions
  • Provide expertise in all phases of drug trials, device trials, data collection studies, and interview-based studies
  • Provide operational and regulatory support for investigator-initiated and industry-sponsored studies that may require an Investigational New Drug or Investigational Device Exemption application
  • Assist with Institutional Review Board submissions and regulatory documents
  • Contribute to protocol development
  • Serve as an initial liaison with pharmaceutical companies
  • Train new and seasoned coordinators
  • Ensure trials are conducted following Good Clinical Practice Food and Drug Administration regulatory guidelines and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines

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