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