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Does your study involve a genetically modified product? Clinical trials involving gene transfer, including cell and gene therapy, chimeric antigen receptor T-cell (CAR T), genome editing, and messenger ribonucleic acid (mRNA), continue to grow, and most of these trials require approval by an Institutional Biosafety Committee (IBC). Sponsors and CROs working with multiple, inefficient Institutional Review Boards (IRB) and IBCs often experience costly study start-up delays.
In partnership with a leading CRO, WCG helped navigate the complexities of a large-scale vaccine trial involving 100 sites. Through strategic initiatives, including proactive site list reviews, relationship-driven collaboration, and adaptive project management, WCG set new standards in efficiency and reliability, ultimately reducing regulatory timelines and streamlining communication for the CRO.
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Discover more best practices and implement them in your gene transfer trial, by downloading the complete case study.
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