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(Lincoln, NE Jan. 11, 2016) – Celerion is pleased to announce that effective January 1, 2016, Assign Clinical Research, headquartered in Vienna, Austria, has joined Celerion, further expanding our global presence and capabilities in the conduct of complex early clinical studies. Assign conducts early stage clinical studies, as well as specialized later stage studies, across a broad range of therapeutic areas with a particular focus in oncology, vaccines, cancer immunotherapy, personalized medicine and autoimmune disorders. They specialize in difficult to recruit clinical studies through relationships with study centers located across 30 countries.
The addition of these capabilities demonstrates Celerion’s strategic focus in responding to our clients’ challenges in drug development. With the increasing importance of incorporating patients earlier into clinical research programs, Celerion’s strengthened service offerings in early phase patient studies provide clients with better information, faster to reach go/no-go development decisions on new drug candidates.
“Assign perfectly complements Celerion’s services in early clinical development,” said Susan Thornton PhD., President and CEO at Celerion. “I am excited to bring two industry leaders together to provide our clients with a highly specialized suite of services which strengthens our competencies in Applied Translational Medicine. The talent and scientific expertise at Assign combined with that of Celerion deepens our position as the global leader in early clinical research.”
“There is a strong cultural fit with Assign and Celerion,” said Klaus Fischer PhD, CEO at Assign. “Both companies are committed to delivering on our clients’ ever-evolving needs in the conduct of complex clinical studies. I look forward to joining the Celerion team to integrate our services and offer clients access to the largest and the most comprehensive global early stage clinical research organization.”
Celerion, a leader in early clinical research, delivers Applied Translational Medicine. Celerion applies our expertise and experience to translating information gained in research discoveries, to knowledge of drug action and effect in humans to support early drug development decisions and the clinical pharmacology labeling of new medicines.
With over 40 years of experience and 600 global clinic beds (including 24 in-hospital), Celerion conducts and analyzes First-in-Human, clinical Proof-of-Concept, cardiac safety (TQT, robust QT), ADME and NDA-enabling clinical pharmacology studies. Celerion provides expertise on modeling and simulation, study design, medical writing (protocols and reports), clinical data sciences, biostatistics, and PK/PD analysis as well as small and large molecule bioanalytical assays through clinical drug development. Regulatory, drug development and program management complement Celerion’s service offerings. For more information please visit www.celerion.com.
Assign specializes in the conduct of complex patient studies across a broad range of therapeutic areas with a particular focus in oncology, immunotherapy, vaccines, personalized medicine, and autoimmune diseases. Assign has been providing clinical development support to pharmaceutical, biotechnology, and medical device companies globally since 2002. The company offers a comprehensive suite of services across all phases of development. Through relationships with study centers in 30 countries, Assign has a strong track record of success in difficult to recruit patient studies. Assign provides expertise in adaptive trial design, clinical data services, biostatistics, clinical conduct, and IMP handling and QP releases for the European Union.