Therapeutic Expertise
Cannabinoid & Psychedelic
We are widely regarded as a market-leading CRO that specialises in cannabinoid and psychedelic clinical trials, serving global sponsors with high-quality, cost-effective and accelerated solutions.
Conducting clinical trials involving cannabinoids and psychedelics requires a meticulous approach to design, ethics, safety, and data collection, alongside collaboration with experts and adherence to regulatory guidelines.
We engage with principal investigators who have a deep understanding of the most suitable pre- and post-dose assessments, as well as access to a broad support network of psychotherapists, psychiatrists, and neurological experts.
Addressing common pain points in cannabinoid & psychedelic clinical trials
Regulatory barriers
Many countries still classify cannabinoids and psychedelics as controlled substances, making it difficult to obtain the permissions needed to conduct trials.
Our regulatory affairs specialists are experienced with global authorities on cannabinoid and psychedelic trials, facilitating efficient navigation and timely commencement.
Complexity of monitoring psychoactive effects
Quantifying and analysing the subjective experiences and potential long-term psychological effects is intricate.
We employ state-of-the-art digital tools and tailored patient surveys, ensuring comprehensive capture of psychoactive effects and long-term impacts.
Safety concerns
Given the psychoactive nature of these compounds, ensuring participant safety — especially in long-term studies — is paramount.
We have specialised safety monitoring boards with experts experienced in psychoactive substances, ensuring the utmost attention to participant safety.
Data management and interpretation
The multifaceted nature of data — psychological, physiological, and biochemical parameters — can be overwhelming.
We use sophisticated data management systems capable of handling diverse, complex trial data, meticulously captured, stored, and analysed.
Blinding challenges
Due to the distinct, often strong effects of these substances, maintaining effective blinding in randomised controlled trials can be challenging.
By leveraging advanced placebo designs and substances with similar non-psychoactive effects, we ensure the integrity of the blinding process.
Frequently asked questions
Cannabinoid & Psychedelic clinical trials — FAQs
Does iNGENū have experience with cannabinoid and psychedelic trials?
Are cannabinoid/psychedelic trial results usable for FDA submission?
How are the unique safety and blinding challenges handled?
The iNGENū CRO difference
Australian expertise, direct FDA submission
We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Trial data from Australia can be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.
iNGENū takes a highly strategic and disciplined approach to clinical research, ensuring every dollar is directed toward generating meaningful outcomes — eliminating unnecessary costs while maintaining the highest scientific and regulatory standards across the Asia-Pacific region.
“We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug — medical writing, project management, clinical data management and full end-to-end execution and monitoring. We have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads during this clinical trial.”
Giles MossChief Executive Officer
Ready to discuss your Cannabinoid & Psychedelic clinical trial?
Talk to our team about how iNGENū CRO can accelerate your research.
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