Cannabinoid & Psychedelic
We are widely regarded as a market-leading Contract Research Organization that specializes in cannabinoid and psychedelic clinical trials.
Conducting clinical trials involving cannabinoids and psychedelics requires a meticulous approach to design, ethics, safety, and data collection. Additionally, collaboration with experts in these fields and adherence to regulatory guidelines is essential to ensure the validity and safety of the research. We service global sponsors with high-quality, cost-effective and accelerated solutions.
Common indications in which we have experience include:
- Cannabinoids
– Chronic Pain
– Epilepsy
– Multiple Sclerosis (MS) - Psychedelics
– Depression (MDD, PDD, Bipolar Disorder)
– Post Traumatic Stress Disorder (PTSD)
– Substance abuse disorders
– Anorexia Nervosa
We engage with PI's who have a deep understanding of the most suitable and transferrable pre- and post-dose assessments as well as access to a broad support network of Psychotherapists, Psychiatrists, and Neurological experts.
Pain points associated with cannabinoid and psychedelic clinical trials
- Regulatory Barriers: Many countries still classify cannabinoids and psychedelics as controlled substances, making it difficult to obtain the necessary permissions to conduct clinical trials.
- Complexity of Monitoring Psychoactive Effects: Quantifying and analyzing the subjective experiences and potential long-term psychological effects is intricate.
- Safety Concerns: Given the psychoactive nature of these compounds, ensuring participant safety, especially in long-term studies, becomes paramount.
- Data Management and Interpretation: The multifaceted nature of data emerging from these trials, which often include psychological, physiological, and biochemical parameters, can be overwhelming.
- Blinding Challenges: Due to the distinct and often strong effects of these substances, maintaining effective blinding in randomized controlled trials can be challenging.
How iNGENū addresses these pain points
- Expert Regulatory Navigators: iNGENū’s team of regulatory affairs specialists are experienced in working with global authorities on cannabinoid and psychedelic trials. We facilitate efficient navigation through the approval process, ensuring timely trial commencement.
- Innovative Monitoring Systems: We employ state-of-the-art digital tools and tailored patient surveys, ensuring comprehensive capture of psychoactive effects and long-term impacts on patients.
- Dedicated Safety Oversight: We have specialized safety monitoring boards with experts experienced in psychoactive substances. They ensure that trials are conducted with the utmost attention to participant safety.
- Advanced Data Management Platforms: iNGENū uses sophisticated data management systems capable of handling the diverse and complex data arising from these trials, ensuring that all data is meticulously captured, stored, and analyzed.
- Rigorous Blinding Techniques: By leveraging advanced placebo designs and using substances with similar non-psychoactive effects, iNGENū ensures the integrity of the blinding process in trials.