Advarra's GTR Network Becomes Largest for CGT Trials with 1,500+ Sites, Doubling Activation Speed

October 4, 2024
Advarra's GTR Network Becomes Largest for CGT Trials with 1,500+ Sites, Doubling Activation Speed
  • Advarra 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


Get a daily email with more Gene Therapy stories

More Stories