Castle IRB is an independent IRB service ready to review your next research study; specializing in gene therapy, cell therapy, and rare disease studies.

Working in close collaboration with our partner IBC service provider, Clinical Biosafety Services, we offer integrated, consistent, and timely regulatory committee reviews of your gene and cell therapy clinical research.

While gene and cell therapy and rare disease projects are 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 / PI studies
  • Multi-Site Studies
  • Review of Natural History studies
  • Registry studies
  • Continuing Review of Research
  • On-Going reviews, including Amendments and Safety Reporting
  • Determinations of what is/is not research requiring IRB review
  • Informed Consent Form Pre-Review/Consultation and development
  • Exempt Determination reviews
  • Generic Materials
  • Human Factors research
  • Single Patient Expanded Access/Compassionate Use

Castle IRB provides exemplary client-service assistance with Study and Site start-up for Investigators and Sponsors/CROs. Concierge level support is available.

Castle IRB follows US DHHS and FDA Regulations, the Belmont Report, ICH GCP and NIH Guidelines as well as local/state laws.

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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.