Advarra's GTR Network Becomes Largest for CGT Trials with 1,500+ Sites, Doubling Activation Speed
October 4, 2024Advarra has expanded its Gene Therapy Ready (GTR) global site network to over 1,500 locations, making it the largest network for cell and gene therapy (CGT) trials.
This extensive network allows sponsors and clinical research organizations (CROs) to initiate trials significantly faster, with GTR sites activating two times quicker than traditional methods.
The GTR network enhances sponsor confidence in conducting complex clinical research safely, as evidenced by its rapid site activation and review processes.
Institutions within the GTR network benefit from customized support and training, enabling them to conduct complex CGT trials safely and efficiently.
Advarra provides comprehensive safety oversight for CGT trials, addressing complex research challenges including regulatory hurdles and logistics.
The GTR network aims to improve patient access to CGT trials, particularly for those in rural areas, by ensuring a broad and diverse site presence.
The U.S. is witnessing a surge in CGT investigational new drug applications, which have more than doubled since 2017, with over 1,000 CGTs currently in clinical development.
In response to the increasing number of CGT submissions, the U.S. Food and Drug Administration (FDA) established the Office of Therapeutic Products in March 2023 to enhance regulatory oversight.
Advarra is recognized as a leader in clinical research technology and regulatory review services, overseeing over 12,000 studies annually and trusted by leading global biopharma sponsors and CROs.
Advarra's GTR sites have surpassed all other institutional biosafety committee (IBC) review providers combined in terms of the number of CGT-ready sites.
Currently, there are over 3,000 CGTs in preclinical development across various therapies in the U.S.
The GTR network was established through a rigorous evaluation process to ensure that sites possess the specialized expertise and infrastructure necessary for CGT research.
Summary based on 2 sources
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Sources
Curated - BLOX Digital Content Exchange • Oct 3, 2024
The Largest Network of Research Sites Vetted to Execute Complexities of Cell & Gene Therapy (CGT) Trials Now Includes 1,500 Sites