Kaitlyn Le

Quality Manager

Kaitlyn Le is an experienced Quality Manager crossing over from five years in the Pharmaceutical/Biomedical regulatory field. She is passionate about developing staff and systems to provide the highest quality services possible while meeting key operation metrics. Kaitlyn is also a weekend road trip warrior, dog person, live music enthusiast and true crime podcast junkie.

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Get in touch with us to discuss IBC services for your clinical trials.

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.