Expert consulting across three service tiers — from early-stage research coordination to FDA clinical trial documentation.
Services are offered in compliance with current federal and state cannabis research regulations.
For US federal agencies (HHS, FDA, NIH), academic institutes, active study sites, cannabis manufacturers, and clinicians. Includes IRB submission documentation — informed consent forms, study protocols, biological and environmental safety plans, and recruitment materials. Also covers site feasibility, grant writing, budget formation, and resource allocation guidance.
Study design, methods, and protocol development for investigator-initiated studies, chart reviews, prospective socio-behavioral surveys, demographics data collection, and population-level industry trends research. Includes biostatistical analysis plans, sample selection, intervention design, and health education material development.
Ongoing support for active study sites. Includes database design and management, regulatory document and SOP development, data analysis, technical assistance, and results interpretation, presentation, and dissemination.
Specialized documentation for study sponsors, CRO organizations, and clinical trial sites. Covers new drug applications, medical device applications, investigator brochures, and full sponsor regulatory document development for FDA submission. For sponsored, interventional clinical trials involving more than minimal risk to subjects.
Schedule a free discovery call — we’ll map the right approach together.
Canna-RE Enterprises LLC provides research consulting services only. We do not manufacture, sell, or distribute cannabis products. All consulting subject to applicable federal and state law.