GCT, a CRO with over 25 years of experience in rare disease clinical trials, is working now on a truly special project focused on an ultra-rare genetic condition affecting brain development.
We are supporting the transition into the clinical development phase by providing comprehensive services, including regulatory submissions, organization of scientific meetings with regulatory authorities, medical writing, and support for selecting IMP manufacturing and logistics vendors. Sponsor together with GCT is preparing for the Phase I clinical trial of potentially life-changing therapy for affected children.
By leveraging our extensive experience in early-stage development, regulatory strategy, paediatric research, and ultra-rare disease studies, we aim to accelerate the development process and help to ensure that children can access this promising treatment as quickly as possible.