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. 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.

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 Cannabinoid & Psychedelic Clinical Trials 

Many countries still classify cannabinoids and psychedelics as controlled substances, making it difficult to obtain the necessary permissions to conduct clinical trials.

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, ensuring timely trial commencement.

Quantifying and analysing the subjective experiences and potential long-term psychological effects is intricate.

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 on patients.

Given the psychoactive nature of these compounds, ensuring participant safety, especially in long-term studies, becomes paramount.

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.

The multifaceted nature of data emerging from these trials, which often include psychological, physiological, and biochemical parameters, can be overwhelming.

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.

Due to the distinct and often strong effects of these substances, maintaining effective blinding in randomized controlled trials can be challenging.

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

iNGENu - FDA
Local Trials, Global Approvals

We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Our seamless integration allows trial data from Australia to be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.

iNGENu - cost efficient
Disciplined, Cost-Efficient Execution

iNGENū CRO takes a highly strategic and disciplined approach to clinical research, ensuring that every dollar is directed toward generating meaningful outcomes. Our trials are designed with efficiency in mind, eliminating unnecessary costs while maintaining the highest scientific and regulatory standards.

iNGENu - APAC
Australian-Headquartered, Asia-Pacific Reach

We provide sponsors with comprehensive trial capabilities across the Asia-Pacific region, offering a seamless combination of cost-efficiency and high-quality clinical trials. We leverage the region's competitive pricing while maintaining rigorous Australian-based project management and clinical oversight.

"We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug. We have used iNGENū for: Medical writing, project management, clinical data management and full end-to-end, clinical trial execution and monitoring.

We have been very happy with all aspects of the management of the clinical trial and have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads for our company during this clinical trial."

Giles Moss
Chief Executive Officer

iNGENu testimonial-logos-monotone-1

Ready to discuss your Cannabinoid or Psychedelic Clinical Trial?