When Catalyst Oncology implements the European Union Clinical Trial Regulation (EU CTR) across Sponsor studies the Site Activation Management (SAM) team is often asked what impact certain elements will have on the submission process. We frequently find ourselves responding with “it depends.” There is no one-size-fits-all approach to clinical research, and the EU CTR is no exception. As clinical trials become more complex and regulations evolve, Sponsors’ goals remain the same: a need for dynamic solutions requiring flexibility and creativity tailor–made to their specific scenarios.
Read three case studies illustrating several challenges our SAM team has mitigated, the opportunities the team has explored with our Sponsors based on their strategies and our approaches with EU CTR and the Clinical Trials Information System (CTIS) process. In these examples, we supported Sponsors throughout the process to ensure efficient regulatory approval timelines.
Read more about the Catalyst Oncology approach to the EU clinical trial process and how we solve challenges for our Sponsors with CTIS.
