Tobacco Risk Evaluation
Accelerated Development For Safer Tobacco Products
For more than 25 years Celerion has performed data driven research in the tobacco/nicotine product industry for the evaluation of potentially risk reducing tobacco and nicotine-containing products. Through either direct design or consulting, Celerion has managed clinical studies ranging from small PK, or exploratory biomarker studies to multi-year programs in support of PMTA and MRTPa applications. To date over 300 studies have been performed leading to a volume of peer reviewed publications as well as FDA Center for Tobacco Products PMTA and MRTPa approvals. In the past six years alone Celerion has analyzed over 35000 samples collected from tobacco-product related clinical trials. Celerion has developed 35+ tobacco biomarker assays-one of the largest fully validated list of assays, on a global platform in the field of tobacco research-to support clinical evaluation, making Celerion uniquely positioned to help get your reduced harm tobacco product to market.
Celerion provides comprehensive services to evaluate your reduced harm tobacco/nicotine delivery product including study design, clinical conduct, program management, bioanalysis, planning and performing statistical analyses, interpreting data and writing reports. This full-service approach creates continuity within your study so that information carries forward into the next phase of the program, saving you time and cost. Our streamlined procedures,automated bioanalytical methods and extensive experience with the endpoints assessed in clinical trials evaluating tobacco products also mean rapid turnaround on the data you need. Additionally, Celerion maintains a Tobacco Product Masterfile (MF0000264) of our bioanalytical validations and methodologies at FDA CTP applicable to PMTA and MRTPa submissions.
Regulatory Expertise and Research Investments
The regulatory and submission requirements for reduced harm tobacco/nicotine delivery products continue to evolve and Celerion scientists remain vigilant to stay updated on changes to the regulatory landscape. We work in the scientific community to learn from and provide feedback to regulators at industry conferences. We offer regulatory strategy support and assistance at agency meetings to ensure all relevant recommendations are addressed within your clinical program. We also invest in technology to stay at the forefront of nicotine delivery product research. Collectively, these efforts ensure that you receive fast, effective evaluations of your reduced harm tobacco/nicotine delivery product.
How Does Celerion Make a Difference in Your Clinical Research?
- Custom clinical facility with separate air handling to accommodate the requirements for trials involving indoor tobacco product use
- We have the most sensitive and selective validated assays in the field of tobacco harm reduction research, with the highest throughput on a global platform in the industry
- We are able to offer tobacco risk evaluation services that meet local statues, despite the tightening of indoor smoking laws that limit research in certain geographies
- Celerion offers global program management of tobacco harm reduction studies providing access to a multitude of partner clinics for larger trials with multiple endpoints