US DHHS and FDA Regulations. The Belmont Report. ICH GCP. NIH Guidelines.

Castle IRB is an independent IRB service ready to review your next gene or cell therapy clinical trial. Working in close collaboration with our partner IBC service provider, Clinical Biosafety Services, we offer integrated, consistent, and timely regulatory committee reviews of your research.

While gene therapy is our specialty, Castle IRB has subject matter experts and IRB members in place to provide IRB review of most types of research. Castle IRB services include:

  • Initial Review of Single Site and Multi-Site Studies
  • Continuing Review of Research
  • On-Going reviews, including Amendments and Safety Reporting
  • Determinations of what is/is not research requiring IRB review
  • Consent Form Pre-Review/Consultation

Services Coming Soon:

  • Exemption Determinations
  • Expanded Access & Emergency Use

Contact Us Today

Mission Statement

The mission of Castle IRB is to protect the rights and welfare of human participants in gene and cell therapy clinical trials while providing efficient, compliant IRB review of research. Using our portfolio of expertise, we strive to be the leading IRB partner in advancing safe, ethical and compliant gene and cell therapy clinical trials to accelerate the next evolution in advanced therapies.