Addiction & Risk Reduction Research
Smoking Cessation / Harm Reduction and Nicotine Containing Products Research
We have extensive experience in designing and running trials of Nicotine Containing Products. We offer full service support from initial consultancy, to give you reassurance on your regulatory strategy, scientific objectives and study design, to the complete conduct of your trial, sample and data analysis and reporting.
We offer the following services for your Nicotine Containing Product trials:
Study Design, Regulatory Services and Set Up
- Support with regulatory strategy and scientific advice from the MHRA and FDA
- Study design and protocol development to achieve your objectives and meet expectations of regulators
- IB and IMPD review and development, as required
- CTA and Device submissions, as required
- Submissions to our Research Ethics Committee
- Long term relationship with our Local Research Ethics Committee, who are familiar with reviewing Nicotine Containing Product research, thus minimising risk of queries during review and resulting in a streamlined the approvals process.
Clinical Trial Recruitment and Conduct:
- Recruitment of trial participants from our extensive database of smokers and e-cigarette users through our dedicated Recruitment team.
- Specialist respiratory chambers with separate air handling
- Overnight stays/confinement in our 48 bed Clinical Pharmacology Unit, with 24/7 clinical cover
- An engaged team highly experienced in delivering trials with intensive procedural timepoints
- Spirometry, Carbon monoxide and FeNO screening
- Questionnaires including Fagerstrom Test for Cigarette Dependence (FTCD) questionnaire, Visual Analogue Scales (VAS) and User Acceptability
- Cognitive function testing in collaboration with our The Science Behind partner
- Electronic Bedside Data Capture with ClinSpark, through virtually connected devices in near real-time and integrated sample tracking system through use of barcodes (“from vein to freezer”)
Laboratory Analysis onsite with integrated Pharmacokinetic analysis
- Analysis of Blood samples onsite with validated assays for nicotine, cotinine and 3′-hydroxycotinine, including rapid turnaround for interim reviews
- Pharmacokinetic analysis, including interim reviews to determine trial progression
Clinical Monitoring, Data Management, Statistics and Reporting
Pharmacovigilance and Medical Monitoring
Project Management from end to end
Ready to take the next step?
Clinical Research into Nicotine Containing Products requires expertise and experience.
