A defined path from first conversation to first patient enrolled.

Pharmaka provides end-to-end site activation for psychedelic clinical trials. Every engagement is structured around a fixed scope, defined milestones, and clear expectations - for both the site and Pharmaka.

Here’s what the flow of engagement looks like

Five activation workstreams, coordinated around the critical path.

Each workstream is scoped, priced, and sequenced against the actual critical path of a site activation. You always know what phase you’re in and what happens next.

01 · Business Development

Site Feasibility and Sponsor Business Development

Assessment of your site’s current readiness for psychedelic Phase II and III trials. Active outreach to sponsors on your behalf. Representation in feasibility conversations and site evaluation visits.

02 · Regulatory

DEA Schedule I Licensure

Preparation and submission support for Schedule I controlled substance licensure. Guidance on physical security requirements, controlled substance storage compliance, and inspection readiness.

03 · Operations

Psychedelic-Specific SOPs

Development of standard operating procedures for drug handling, dosing rooms, and patient monitoring - built to hold up under sponsor and regulator review.

04 · People

Staff Training and Facilitator Network

Training for principal investigators, coordinators, and clinical staff on psychedelic clinical trial protocols. Guidance on facilitator recruitment and credentialing, including the mental-health credential requirements for lead and assistant facilitators.

05 · Audit Readiness

Site Evaluation Visit Preparation

Pre-audit dry runs, documentation review, and preparation for sponsor site evaluation visits. Real-time support during on-site visits.

Every activation runs as one coordinated engagement with two components. A fixed monthly retainer covers the continuous work - sponsor outreach, regulatory strategy, SOP development, and staff guidance - across the life of the engagement. Alongside it, milestone payments are tied to specific, verifiable events, so a meaningful share of the fee is earned only as your site actually advances.

Three milestones anchor that structure:

  • 01 Feasibility acceptance Written confirmation from the sponsor that your site is accepted into the study.
  • 02 DEA Schedule I licensure The DEA Certificate of Registration issued to your site.
  • 03 Site activation Sponsor clearance confirming your site is ready to begin participant recruitment.

Because those milestones are real regulatory and sponsor events, you’re paying against progress rather than billable hours. Scope, timeline, and structure are set in writing at the start and adjust only by mutual agreement, and a study contingency clause protects both parties if a qualifying study cannot be sourced. Exact figures are walked through on our first call.

  • 01 Phase III psychiatric trial history MDD, GAD, bipolar, schizophrenia, PTSD, or a comparable mental-health indication.
  • 02 Board-certified psychiatrist or clinical neuroscience PI on staff
  • 03 Raters experienced with standard mental-health assessments MADRS, CAPS-V, HAM-A, and comparable instruments.
  • 04 Existing DEA-registered controlled substance handling Any schedule - nice to have but not required.
  • 05 Infrastructure that supports a low-stimulation dosing room Nearby, or ideally a directly connected private bathroom.

We’d rather name our limits than overpromise.

There are important things Pharmaka does not do. Being clear about them protects the quality of the work we do deliver, and gives you a truthful picture of what we can and cannot control.

  • - 01 Patient recruitment or marketing Patient recruitment for psychedelic studies is typically handled by specialized vendors contracted directly by the sponsor.
  • - 02 Clinical trial operations during study conduct Our work concludes once your site is activated and ready to enroll. Study conduct is your site’s domain.
  • - 03 Guarantees of specific study placements Final site selection is always the sponsor’s decision. We advocate for your site and prepare you to compete for any available study - we don’t promise a specific one.

Pharmaka also works with clinical research site networks. Multi-site engagements offer tiered volume pricing and include network-level advisory on regulatory strategy, sponsor business development, and audit readiness - applied across your entire portfolio rather than one site at a time.

The result is a coherent activation strategy that lets you sequence sites intelligently, deploy shared SOPs where appropriate, and present the network to sponsors as a single, coordinated capability.

Every activation starts with a conversation.

A focused conversation to review your current readiness, discuss your goals, and determine whether Pharmaka is the right fit for the road ahead.

Direct contact

kevin@pharmakaclinical.com

+1 (954) 536-8118

San Francisco Bay Area, California