Complex multi-site early patient studies on a global scale.
Speed, Flexibility, Agility, Quality; all of the above is what is required in today’s rapidly changing clinical and regulatory environments. As “the right size” CRO Celerion is well-positioned to adapt to the ever increasing complexity of clinical trials. Whether they are difficult to recruit trials in rare or orphan indications, multi-arm trials with sophisticated IMP setup complex logistic, or trials with heavy recruitment competition, we have the ability to deliver robust and reliable results.
If you are looking for adaptive clinical trial designs, our experienced clinical, pharmacology, kinetics and biostatistics teams will work with you to tailor a solution to your unique needs. The clinical research professionals at Celerion have extensive experience and expertise in managing complex patient studies, helping you to transition through Proof of Concept and beyond with a particular focus on the following disease areas:
Celerion has successfully supported oncology studies covering over 25 indications within this complex therapeutic area. Our experience across disease states, counties and therapeutic modalities will add value to your study by providing access to key investigators, experienced study centers, networks of specialized labs (CTC/DTC/PBMC), insightful study design and highly skilled project teams. Celerion has designed and conducted programs in the rapidly expanding area of clinical immuno-oncology trials in indications such as prostate cancer, ovarian cancer and colorectal carcinoma, to name a few.
Our non-oncologic immunotherapy trial experience includes indications such as lupus erythematosus, psoriasis, rheumatoid arthritis and Crohn’s disease. Celerion has also run a vast number of trials in autoimmune diseases such as rheumatoid arthritis, psoriasis, multiple sclerosis, just to mention a few. We possess the right network and the expert personnel in this broad area to offer you the best solutions for your trials.
At Celerion, we understand the importance of timing, experience and flexibility for the successful execution of a vaccine study, which is why all our vaccine studies have been completed on time and on schedule. Our track record spans both preventive and therapeutic vaccines, subunit and conjugates in more than 20 countries, 300 study centers and 4500 subjects.
Celerion has supported several highly personalized dendritic cell studies, as well as protein fragment-based therapeutic cancer vaccine projects. Through this, we have gained tremendous insight and knowledge into the conduct, therapeutic necessities, recruitment issues and logistics of personalized medicine studies.
Infectious Disease (Viral or Bacterial)
Celerion has conducted studies for a broad number of different viral or bacterial infections, including HIV, Hepatitis C and has performed studies with intensive care unit settings. Our experience encompasses all phases, including epidemiological studies.
Celerion’s experienced and knowledgeable scientific and clinical operational team can help navigate NAFLD/NASH drug development programs through this emerging market. Our scientific and clinical operational staff has the experience and thorough understanding of the disease as well as bioanalytical and non-invasive measurements of hepatic lipid metabolism, inflammation and fibrosis. Additionally, we have a strong recruitment track-record to support special-population studies like diabetes, obesity, NAFLD programs.
In managing pharmacokinetic/safety studies in patients with renal insufficiency, Celerion works with specialty sites to conduct these studies that are often required as part of the marketing application for new drug (NDA, MAA) per the requirements outlined by FDA guidance.
Respiratory Disease (Asthma, COPD, Cystic Fibrosis
Celerion has conducted a number of studies that include mild to moderate and severe asthmatics, COPD and Cystic Fibrosis patients. Due to an increasing demand from clients for analysis of BAL samples, our dedicated Bronchoscopy Suite offers on-site access to this procedure. Celerion is able to leverage its clinic facilities, biomarker analysis capabilities, PK/PD analysis skills and program planning experience to generate “fast-to-patient” strategies that minimize the time to key go/no-go decisions.
Other Therapeutic Experience
- Neurodegeneration (Alzheimer’s Disease, Parkinson’s Disease)
- Personalized Medicine
Celerion’s Global Clinical Development team works within a robust Quality Management System to ensure high-quality results demanded of a highly regulated industry.
- Save precious time and budget with experienced project managers and streamlined processes.
- Gain valuable insight from protocol development through study conduct and analysis through Celerion’s accumulated experience of nearly 1000 studies in over 30 countries.
- Mitigate risk through early problem identification, implementation of mitigation strategies, and through close monitoring of project plans and key project and decision drivers
- Coordination between all functional areas, streamlined communication and a flat organizational structure facilitate execution by well-trained and organized teams with rapid access to senior management.
- By tailoring monitoring plans to each specific study, whether using our CORE Monitoring approach, a compliance-oriented monitoring process taking into account each particular study site, deploy risk-based monitoring, or a custom solution, Celerion assures compliance and data integrity.