We manage complex Cell & Gene therapy clinical trials for multiple sponsors in oncology, rare diseases and other therapeutic areas. They choose us because we understand the complexities of how to operationalize cell and gene therapy trials and deliver quality results on time. Our teams, processes and technologies thrive on delivering results in a fast-paced landscape.
Cmed understands the particularities of ATIMP trials and how to overcome the associated operational challenges. Some examples of ATIMP trials we have worked on:
Cell and Gene Therapy studies are adaptive in nature, have multiple arms and require very tight control over trial progression. These studies are subject to rapid and numerous mid-trial amendments requiring flexible teams. Our Project Leaders have a thorough understanding of the implications of the trial design to have the ability to lead a multi-functional team focused on recurring deliveries.
You can trust our expertise in GMO and knowledge of country specific ethics requirements. Use our experience in selection and management of applicable countries/sites to guide you through the complex submissions and approval process.
Handling of the investigational product requires more stringent processes and management, yet should be written in a manner which flows with site standard process to avoid additional start up delays. We have experience liasing with the site for each individual patient.
The nature of these complex trials makes them subject to constant data review. Our data management team has expertise in the management of high volumes of data. Our biostatistics team provides input into protocols and drives on-going deliveries. In addition, our technology enables you to review all the data in one single place enabling rapid decisions.