WARSAW, Poland, Sept. 4, 2024 /PRNewswire/ — Axcellant, a European CRO based in Warsaw, Poland, is excited to announce the launch of a groundbreaking clinical trial in nuclear medicine. The new project could change the standard care pathway, including innovative diagnostics for over 20 million patients in the US and over 200 million worldwide.
– For a European client, we are currently developing a new radioactive compound that is a great candidate for a new diagnostic agent. We are initiating the study in about 20 sites in the US on the East Coast and Midwest. Our team’s experience with nuclear agents in oncology, cardiology, and neurology has enabled us to build deep expertise in this field. We have also engaged leading experts and Key Opinion Leaders from across the United States, including San Francisco, Houston, New York and Rochester, to support this innovative trial – says Wojciech Kula, CEO of Axcellant, a European CRO based in Warsaw, Poland.
FDA inspections confirm that Europe is an excellent market with fast patient recruitment and high-quality clinical sites. Axcellant has been in the market since 2006 and has successfully carried out projects for American companies. With extensive experience in various therapeutic areas, Axcellant excels in conducting sophisticated trials, particularly in nuclear medicine. Their expertise spans multiple stakeholders, including manufacturing transfer, central imaging labs, and MRI/PET imaging site management.
– We are working on starting up the first manufacturing sites in the forthcoming months and activating clinical centres. The FDA agreed with the clinical development plan and structure of the study without any significant remarks, which gave us confidence in our procedures – adds Wojciech Kula.
Running a clinical trial is an investment that can usually range from 20-80 million USD, and it’s spread out over time—it may take up to 15 years. That’s why it’s all worth it for such a “long journey” to have a knowledgeable partner who is deeply dedicated to their work and has experience in even the most challenging projects.
About Axcellant
Axcellant is a Clinical Research Organization (CRO) based in Warsaw, Poland. It was founded by Wojciech Kula and Patrycja Buczak-Kula, pharmacists with over 15 years of clinical trial experience. Axcellant helps pharmaceutical, biotech, and medtech companies develop new molecules and innovative devices or technologies. https://axcellant.com/
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SOURCE Axcellant
