Market-Leading CRO
Cannabinoid & Psychedelic
We are widely regarded as a market-leading CRO that specialises in cannabinoid and psychedelic clinical trials.
Conducting clinical trials involving cannabinoids and psychedelics requires a meticulous approach to design, ethics, safety, and data collection. We service global sponsors with high-quality, cost-effective and accelerated solutions. 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.
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
Disciplined,
Cost-Efficient Execution
while maintaining the Highest Quality
Local Trials,
Global Approvals
Access FDA Regulatory Expertise
Our Clinical Team has over
120
years
of Combined Clinical Trial Experience
Addressing Common Pain Points Associated with Early-Stage Clinical Trials
Regulatory Barriers
Problem:
Many countries still classify cannabinoids and psychedelics as controlled substances, making it difficult to obtain permissions.
iNGENū CRO addresses this pain point with iNGENū CRO addresses this pain point with 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.
Complexity of Monitoring Psychoactive Effects
Problem:
Quantifying and analysing the subjective experiences and potential long-term psychological effects is intricate.
iNGENū CRO addresses this pain point with iNGENū addresses this pain point with 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.
Safety Concerns
Problem:
Given the psychoactive nature of these compounds, ensuring participant safety, especially in long-term studies, becomes paramount.
iNGENū CRO addresses this pain point with iNGENū addresses this pain point with 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.
Data Management and Interpretation
Problem:
The multifaceted nature of data emerging from these trials, which often include psychological, physiological, and biochemical parameters, can be overwhelming.
iNGENū CRO addresses this pain point with iNGENū addresses this pain point with 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 analysed.
Blinding Challenges
Problem:
Due to the distinct and often strong effects of these substances, maintaining effective blinding in randomized controlled trials can be challenging.
iNGENū CRO addresses this pain point with iNGENū addresses this pain point with 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.
The iNGENū CRO Difference
Local Trials, Global Approvals
We uniquely combine Australian expertise with direct FDA submission capabilities.
Disciplined, Cost-Efficient Execution
iNGENū CRO takes a highly strategic and disciplined approach to clinical research.
Australian-Headquartered, Asia-Pacific Reach
We provide sponsors with comprehensive trial capabilities across the Asia-Pacific region.
We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug. We have been very happy with all aspects of the management of the clinical trial.
Ready to discuss your Cannabinoid & Psychedelic Clinical Trial?