Veristat is a business services company based in the United States, specializing in research and development within the biotech and pharmaceutical sectors, as well as providing legal services and software solutions. Founded in 1994, the company has grown to employ between 501 and 1,000 individuals and reported revenue of approximately $105 million. Veristat's expertise is particularly evident in the area of clinical trials, as highlighted in their recent publication on single-arm studies as registrational studies in oncology. This document discusses the design and regulatory considerations of single-arm trials, which are non-randomized studies where all participants receive the same treatment. It outlines scenarios where single-arm trials may be appropriate, such as in cases of significant medical need or when randomized controlled trials are not feasible. The publication also addresses the potential benefits and limitations of this study design, emphasizing the importance of careful endpoint selection and regulatory planning. Overall, Veristat's focus on innovative clinical trial methodologies reflects its commitment to advancing healthcare solutions.