The site activation partner for psychedelic clinical trials.
Pharmaka Clinical Consulting helps established research sites get ready to participate in psychedelic clinical trials. Regulatory strategy, DEA Schedule I licensure, staff training, and sponsor readiness, delivered by a PharmD with late-stage clinical development experience at a gold standard biopharma company.
Psychedelic clinical research has moved from fringe to Phase III.
Federal policy is shifting in favor of psychedelic medicine, the FDA is actively prioritizing it, and dozens of drug development sponsors are running trials now, looking for sites that are ready. The challenge is that readiness takes time. Most sites need 9 - 18 months to achieve DEA Schedule I licensure, train staff, and develop standard operating procedures. Sites that start that process early, and have a knowledgeable guide supporting them, get selected. Sites that wait don't.
That's where Pharmaka comes in.
Meet Our Founder: Kevin Lanzo, PharmD
Dr. Kevin Lanzo is a clinical pharmacist and site activation specialist with a career built at the intersection of late-stage pharmaceutical development and psychedelic clinical research.
Kevin spent five years at Roche/Genentech in late-stage clinical development, working on the clinical strategy for novel psychiatric medications, including investigational psychedelics and psychoplastogens. He founded Pharmaka Clinical Consulting to help established research sites participate in the emerging psychedelic Phase III landscape.
Professional Memberships
Thinking about bringing psychedelic clinical trials to your research site? Reach out via this form.
Let's talk about where your site stands and what it would take to get there.