With the explosion and a pipeline set for decades to come, we understand time is essential for gene and cell therapy drug development where IBC and IRB review is required. That is where CBS and Castle IRB enter. With our industry standard white glove service, we reduce the bureaucracy for sponsors, offer unparalleled communication through study start-up, and simplify the process.

Where you have sites who need an IBC, or established acamedic medical centers, our IBC Risk assessment services (inter-site link here) and Concierge Submission Support (inter-site link here) will impact the entirety of your trial, reducing the study start-up, and accelerate the goal of opening and enrolling patients, sooner.

Gene and Cell Therapy Sponsors, our people are virologists, geneticists, clinicians, pharmacists, biosafety professionals. We get you. Now, let us help you.

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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.