We know and understand. One more regulatory submission for a study coordinator to submit, only this one involves cell and gene therapy. Rather than have study coordinators and principal investigators navigate the challenging submission process to their local Institutional Biosafety Committee (IBC), CBS off-loads this burden for researchers by completing and guiding study teams through the process.

How? Because of people, and expertise in biosafety and gene therapy, we can navigate the IBC submission process at each site. For Sponsors and CROs, this is critical in revealing time lines and study-stary-up. For principal investigators and their study teams, this removes the headache and burden of yet one more regulatory submission. For Institutions, this results in trained study teams with completed submissions, reducing workload and burden on institutional staff.

Contact us to learn more, today, on how Concierge can accelerate your gene and cell therapy study start-up.

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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.