As a leading provider of early clinical research services for 40 years, Celerion is right-sized to deliver a comprehensive spectrum of clinical pharmacology services in an integrated yet flexible way to meet the unique demands of each drug development program.
Our clients value the planning, execution, analysis and reporting services that Celerion provides to meet their individual early clinical drug development needs.
New Drug Candidates
Celerion collaborates with both emerging and established pharmaceutical and biotechnology companies to test new drug candidates in humans for the first time and help with rapid but safe progression of these agents to Clinical Proof-of-Concept (CPoC). CPoC is reached when sufficient evidence is collected to demonstrate the drug is working as planned, and to stimulate further investment in the drug’s clinical development. Reaching this critical milestone usually involves administration of the therapy to normal subjects as well as patients in the target disease population and often involves the deployment of specific biomarkers of drug effect.
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. We have actively invested in new technologies to enrich data collection and analysis and to expedite data delivery to our clients.
Celerion collaborates with pharmaceutical companies seeking market approval for new drugs in packages of studies that form the basis for specific labeling claims in their applications. These “NDA/MAA-enabling studies” include drug-drug interaction, thorough QTc assessments, hepatic and renal insufficiency, human ADME studies with radiolabeled drugs, special population studies (elderly, genetic or ethnic subpopulations), and final market form bioequivalence work. With four clinics and two bioanalytical laboratories in the US and Europe, all working to the same SOPs and common data capture and analysis systems, Celerion has the capacity to manage the execution of several studies simultaneously to ensure that submission timelines are not compromised.
Companies developing generic versions of marketed drugs utilize Celerion’s long-standing expertise and experience in the conduct of bioequivalence studies for market registration. Our scientists have successfully deployed adaptive and multiple treatment period designs to optimally manage bioequivalence studies of drugs with highly variable pharmacokinetic characteristics. Celerion is participating in the emerging area of biosimilar drug development by leveraging biologics regulatory expertise, proven large molecule and immunogenicity bioanalytical support, clinical study planning and execution and biopharmaceutics program development.