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.

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Mission Statement

Our mission and expertise at Clinical Biosafety Services is to provide accelerated, compliant review of gene transfer/gene therapy clinical trials to a convened review of a site-specific Institutional Biosafety Committee (IBC). We do this by understanding the challenges in the two client relationship of serving an institution and a sponsor.

Our focus is to accelerate the trial, and remove regulatory burden and uncertainty by having our highly trained experts provide friendly, knowledgeable support during the review process. We understand these therapeutics will change medicine, and our service is to bring the trial to enrollment fruition, quickly and compliantly.