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