There is currently a gap in the evidence regarding the benefits and the potential harm from cannabis since its legalization and increased availability. A ‘pragmatic clinical trial’ is one approach utilized to investigate the impact of a cannabis product. It focuses on correlations between treatments and outcomes in real-world settings. The advantage of this approach is that it provides causative explanations for outcomes therefore the trial results are more relevant to real-world users.
Cannabis Clinical Trials
We have considerable experience conducting Phase 1 – 3 cannabis trials, utilizing efficient study designs, and risk-based monitoring methodologies to provide scientific evidence of cannabis product efficacy for either medical or neuro enhancement purposes. We can provide tailored impairment window information for various products through the statistical analysis of data gathered via a clinical trial. This can be generated irrespective of the route of administration or its formulation. In addition, we can also generate evidence on the following conditions and experiences:
- Anxiety and mood enhancements
- Pain management
- Eating disorders
- Dermatological uses of cannabis
- Sleep and relaxation
- Creativity and socializing
Cannabinoid Clinical Trials
- Cannabis study design and protocol development relevant to the research questions under investigation
- Develop project budget in conjunction with client. Our budget development process is flexible; we can generate knowledge with various budget sizes
- Using mobile and electronic data collection tools to improve efficiency and ensure data integrity.
- Innovative recruitment models using social media, event and partner network.
- Successfully achieve ethics committee approval via accredited Institutional Review Board (IRB) for our USA projects or Review Ethics Board for Canadian projects.
- Development and submission of scientific publications in journal or conferences
- Consent management process
- Secure patient data
- Prepare statistically valid Marketing statements and product information messages from trial data
- Successfully execute your study.
- Development of essential study documents such as SOPS