Human gene therapy is a rapidly growing area, as evidenced by the growing number of clinical trials initiated where an Institutional Biosafety Committee (IBC) or Genetically Modified Organism (GMO) risk assessment review is required. IBC review and oversight are a critical component for reducing risks to study staff, research participants, and the environment involving genetically modified biological materials. Sponsors, institutions and sites that have either received NIH funds or are conducting NIH-funded studies involving gene therapy are required by the United States NIH Guidelines to have IBC oversight.

CBS Provides Turn-Key IBC Review Services:

  • A centralized IBC solution to establish site specific IBC or IBCs, including flexible and comprehensive support for IBC setup, registration and administration
  • Resources and support for an existing IBC in accordance with NIH Guidelines, through staffing, a second IBC, or other institution specific needs.
  • Coordination of concurrent reviews to deliver efficient, time-saving IBC and institutional review board (IRB) reviews for all participating research sites through our Castle IRB subsidiary.
  • Global support for IBC services as research with the NIH Guidelines goes beyond US borders.

Ready to submit a project for a CBS risk assessment review?

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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.