At Celerion, we have strong experience and expertise in many of the unique aspects that define early clinical research with respiratory and inhaled drug products. We help our customers navigate the complex challenges of respiratory clinical trials through our experienced clinical development team, our Center of Excellence and our industry leading bioanalytical capabilities.
We are ready to help you with your respiratory study by applying our deep relationships with key opinion leaders. Our robust team of project managers specialize in the unique aspects multi-site clinical recruiting, monitoring, specialty sample processing and direct management of important biomarker assays. Our specialization lies within six respiratory disease areas: asthma, COPD, cystic fibrosis, bronchiectasis, chronic cough and idiopathic pulmonary fibrosis.
Celerion offers a Clinical Center of Excellence in our Belfast clinic, including challenge models for bronchoconstriction and pulmonary inflammation, pulmonary sample collection, and full spectrum of pulmonary function tests. Our specialized clinic for respiratory research is supported by staff specifically trained in techniques and equipment used for respiratory clinical research studies. Additionally, Celerion employs a Qualified Person (QP) in our pharmacy that is licensed to accept imports of experimental drug into the pharmacy. Our QP process makes it easy for products coming from all over the world to conduct early clinical research in our Center of Excellence in Belfast by simplifying the drug importation and transfer steps.
Our two bioanalysis laboratories (Zurich, Switzerland and Lincoln, NE) are known for their expertise in developing and validating sensitive assays that precisely measure the concentration of small and large drug molecules and important metabolites in biological fluids. Most respiratory tract diseases are associated with pulmonary inflammation and so biomarkers of inflammation can be important measures of drug effect if appropriate samples can be obtained. For larger drug molecules (peptides, proteins, modified nucleic acids) it is important to measure the consequences of drug treatment on the immune response. Celerion’s laboratories are experts at this type of immunogenicity assessment from years of working with protein/antibody drug candidates.
Challenges Of Cystic Fibrosis Trials
Celerion Insights Into Solutions For The Challenges Of Early Stage, Exploratory Cystic Fibrosis Clinical Trials