Clinical development
Material built around the protocol, not the harvest.
Pharmaceutical companies can develop THC and cannabis derived medicines and run clinical trials, provided the product is manufactured, controlled and supplied under the appropriate clinical trial and controlled drug regulatory framework. Regulatory guidance specifically covers botanical cannabis materials, extracts and highly purified cannabis derived substances as investigational human drugs.
Priority indications
Six areas we are built to support.
Rather than claiming dozens of indications, we focus on the areas where cannabinoid evidence is strongest and where sponsors are already running programmes.
Cancer supportive care
Chemotherapy induced nausea and vomiting, cancer pain, appetite loss, sleep disturbance and quality of life. Human trials have studied cannabis and cannabinoids across each of these endpoints.
Chemotherapy induced nausea and vomiting
One of the most commercially validated cannabinoid indications. Dronabinol and nabilone are established cannabinoid medicines in chemotherapy associated nausea and vomiting.
Chronic and neuropathic pain
Particularly where conventional analgesics are inadequate. Cannabinoid research has examined chronic pain and palliative care populations, including opioid sparing endpoints.
Multiple sclerosis spasticity
An established area of cannabinoid medicine and a clear candidate for further formulation and dose research.
Appetite stimulation and cachexia
Cancer related and HIV related wasting. Dronabinol, a synthetic form of delta 9 THC, already has established medical use here.
Palliative medicine
Composite endpoints across pain, appetite, nausea, sleep and overall quality of life rather than a single symptom in isolation.
Exploratory
Areas we watch rather than promote.
Opportunity exists here, but the strength of evidence and the development risk vary considerably. We are open to supplying research quantities while being clear about that position.
- PTSD and anxiety
- Sleep disorders
- Inflammatory conditions
- Opioid sparing pain management
- Selected neurological conditions
Worked example
How a request becomes a shipment.
A sponsor might approach us with a defined requirement. The rest of the work is ours.
We need a standardised high THC extract containing 20 mg per mL of delta 9 THC for a Phase II neuropathic pain study.
From that single sentence we plan the cultivar, the grow window, the extraction and standardisation route, the analytical panel, the batch release documentation, the stability programme, the Jamaican export permit and the handover to the licensed importer and trial manufacturer. The sponsor receives one specification, one data pack and one point of contact.
Follow the full operational process
Sponsor responsibilities
What sits on your side of the line.
We are the supply and documentation partner. The sponsor holds the regulatory relationship in the destination country.
- An investigational new drug application or the local equivalent
- CMC information characterising the investigational product
- Clinical protocols and ethics approvals
- Appropriate manufacturing controls
- Controlled substance authorisations where the material is scheduled
Jamaican law defines permitted medicinal, therapeutic and scientific purposes to include research, clinical trials, therapy and the manufacture of pharmaceuticals. Holders of a Cultivator, Processing, Retail or Research and Development licence may apply to the Cannabis Licensing Authority for an export permit, with quantities determined per application.
Bring us a protocol and a specification.
We will tell you what is feasible from Jamaica, what documentation we can produce and what you will need to hold in the destination country before the first shipment moves.