Fullmoon clinical Consulting
Advisory services for organizations building psychedelic-assisted therapy programs, drawing on experience across clinical operations, psychotherapy, and clinical research.
Book a ConsultationAbout Poonam
My work sits at the intersection of psychedelic medicine, clinical training, and organizational design. I previously served as Director of Commercial Development at Usona Institute, where I led the investigator-initiated trial program for a psychedelic drug development candidate, guiding investigators through program intake, controlled substance licensing, and trial readiness, in partnership with regulatory teams.
I currently serve as a Commercial Development Advisor to The Synthesis Institute, and I’m completing my Masters of Social Work with a clinical concentration at Sacred Heart University, with a research focus on equitable access to psychedelic-assisted therapy. I work with organizations building psychedelic-assisted therapy programs, advising on program structure, staffing, and trial navigation. Current engagements include advising an academic-affiliated clinical program on a new site build-out, serving as an advisory resource for an academic medical center developing its own psychedelic treatment program, and contributing to national conversations on ownership and governance models for independent psychedelic clinics.
Consultation Based on Following
Whether you’re building a new program or preparing an existing practice to add one, these two areas often overlap depending on where your organization is starting from.
Book Your ConsultationClinical Program & Organizational Development
As psychedelic therapies move through FDA review, and toward the rescheduling and program requirements (such as REMS) that would follow approval, organizations need to build clinical and organizational infrastructure now to be ready. This includes support for currently available options like ketamine-assisted therapy.
Topics may include:
Program structure, organizational design, and operational workflow (intake, documentation, EHR systems)
Staffing structure and role definition for clinical programs
Supporting organizational coordination between psychotherapy and psychedelic-assisted treatment teams
Assessing organizational readiness for adding psychedelic-assisted therapy to an existing practice
Assessing business model and payment structure planning (e.g., insurance-based vs. cash-pay models)
Helping identify what agreements and partnerships are needed with universities and commercial partners, alongside clients’ legal counsel
Clinical Research & Investigator-Initiated Trials
As investigator-initiated trials remain the primary path to studying psychedelic compounds ahead of broader FDA approval, organizations and investigators need experienced guidance navigating research pathways, trial readiness, and regulatory requirements, including the licensing, documentation, and institutional coordination that make these trials possible.
Topics may include:
IIT navigation and trial readiness
Controlled substance licensing and regulatory submission support
Coordination on research and trial-related agreements with legal counsel and institutional partners
Support with letters of intent and program documentation for grant applications and trial readiness
Guidance navigating trial sponsor and institutional relationships
Mapping the research and trial landscape to identify potential study or partnership opportunities
Disclaimer: Fullmoon Clinical Consulting provides organizational, regulatory, and programmatic advisory services. It does not provide clinical, medical, or therapeutic advice, direct patient care, or clinical supervision. Fullmoon Clinical Consulting does not provide legal advice. Clients should work with their own legal counsel on all contracts and agreements.
FAQs
Have questions about our services? Explore these frequently asked questions.
Academic medical centers, health systems, independent clinics, and investigators building or supporting psychedelic-assisted therapy programs. No. Remembrance Coaching and the supporting offerings are not therapy and do not involve diagnosis or treatment of mental health conditions. This work is educational, reflective, and nervous-system–centered. It focuses on awareness, regulation, and embodied self-understanding. If therapy or clinical support is needed, referrals are always honored and encouraged. We also do not accept insurance at this time.
No. Fullmoon Clinical Consulting is an advisory service. I don’t provide direct patient care through this service line. Pricing reflects the type of work, session format, and the context you’re coming in with. Because each person, relationship, or organization has different needs, details are discussed during a complimentary discovery call. This conversation helps us explore how the work might fit you and talk through options with clarity and care, without pressure or obligation.
Every engagement starts with a conversation about your organization’s specific goals and needs. From there, the scope of work is defined together, drawing on whatever mix of organizational, research, or regulatory support is relevant to your project. That’s very common. Many people start with Remembrance Coaching as a way to slow down, be met, and listen inward before choosing anything else. You’re also welcome to schedule a complimentary discovery call to ask questions and sense what feels supportive. There’s no right order and no pressure to decide everything at once.
It varies by project scope, from short, focused advisory projects to multi-month engagements depending on what’s needed. No. Many people begin this work without a clear issue or goal. You don’t need to be in crisis, and you don’t need to have the right words. Often, people arrive simply sensing that something wants attention or that the current way of being isn’t quite sustainable. The work meets you where you are and unfolds from there.
It depends on the compound. An esketamine-based treatment (Spravato) is currently the only FDA-approved option in this category; other forms of ketamine therapy are used off-label. Other psychedelic compounds are still moving through FDA review and, even after approval, would need to go through drug rescheduling and program requirements (such as REMS) before reaching clinics. Outside of clinical trials and state-regulated programs in Oregon and Colorado, these compounds are not currently approved for therapeutic use in the U.S. My work helps organizations build readiness for these anticipated changes while navigating what’s available today.
Ready to Get Started
Take the first step toward healing. Get in touch and we’ll walk with you from there.
