The AI-Native Operating System for Psychedelic Clinics
VistaraOS replaces the patchwork of EHR, eCRF, scheduling, and compliance tools with a single AI-orchestrated platform — purpose-built for ketamine, psilocybin, and MDMA-assisted therapy.
HIPAA-aligned · 21 CFR Part 11-ready · SOC 2 in progress
Purpose-built for the full spectrum of psychedelic medicine
Psychedelic medicine doesn't fit conventional clinical software
The protocols are different. The risk profile is different. The regulatory path is different. Forcing the work into general-purpose EHRs creates fragility, errors, and clinician burnout.
Stitched-together tools
Generic EHRs, separate eCRFs, spreadsheets, and Calendly. Data lives in five places — clinicians live in tabs.
Modality-specific protocols ignored
Set-and-setting prep, integration sessions, and dosing-day workflows don't fit standard medical software.
Compliance written after the fact
SOPs, audit trails, and 21 CFR Part 11 e-signatures bolted on with PDFs and folders. Audits become fire drills.
Trial ops drown clinic ops
Sites running both commercial care and sponsored trials juggle two systems, two SOPs, and double the burden.
Everything the clinic needs, on one intelligent backbone
Patient journey, end to end
- Intake, screening, and eligibility scoring
- Preparation, dosing, and integration session notes
- Outcome tracking with PHQ-9, GAD-7, MADRS, CSSRS
- Patient portal for forms, consents, and check-ins
- Patient companion app for journaling between sessions
Trial operations, native
- eCRF, eConsent, and ePRO in one system
- Visit windows, protocol deviations, and AE tracking
- Sponsor data exports (SDTM-aligned)
- Source-data verification with audit trail
Compliance you can audit in minutes
- HIPAA-aligned access controls and PHI segmentation
- 21 CFR Part 11 e-signatures and immutable audit log
- GCP-ready SOPs and training tracking
- DEA Schedule I/III chain-of-custody for controlled substances
Clinic operations, automated
- Scheduling that respects dosing-day staffing rules
- Inventory and controlled-substance reconciliation
- Billing, claims, and self-pay workflows
- Staff credentialing and shift handoff
Chat with your clinic. Get insights, unprompted.
AI Operator is a chat interface to every system in your clinic — patient records, scheduling, finance, trials, compliance. Ask anything. And when something needs attention, it surfaces the insight before you have to look.
Ask anything about your clinic
Natural-language queries across patient data, scheduling, finance, trial ops, and compliance. Answers come with a citation back to the underlying record.
Insights that surface themselves
Visit-window slips, suicidality language, controlled-substance discrepancies, declining outcomes — flagged the moment they appear, with a suggested next action.
Knows your protocols and SOPs
Trained on your operating model: who can do what, which fields matter, how your specific clinic runs. Not a generic chatbot reading public documentation.
Every action logged and reversible
Clinicians remain the licensed decision-maker on every clinical step. AI prompts, suggestions, and outputs are stored alongside the chart for audit and review.
Human-supervised · every prompt and response logged · clinician-approved before any chart write
The full shape of the work, covered out of the box
Intake & screening
- Configurable intake forms
- Insurance and self-pay routing
- Eligibility scoring against protocol criteria
- Automated referral acknowledgements
Dosing day
- Pre-dose checklists and vitals capture
- Dosing-room scheduling with sitter pairing
- Real-time observation notes
- Post-dose monitoring and discharge readiness
Integration & follow-up
- Integration session templates
- Patient journaling app with care-team visibility
- Outcome scale cadence (PHQ-9, GAD-7, MADRS)
- Relapse and suicidality alerts
- Long-term follow-up scheduling
Trial coordination
- Protocol library with version control
- Visit calendar with windows and tolerances
- Source-data verification queue
- Monitoring visit prep
Regulatory & quality
- AE / SAE capture and narrative drafting
- Deviation log with CAPA workflow
- SOP library with attestation tracking
- Inspection-ready evidence export
Clinic operations
- Controlled-substance inventory and reconciliation
- Staff credentialing and training expirations
- Billing with psychedelic-specific CPT/HCPCS
- Financial reporting and cohort analytics
Built for the most regulated corner of healthcare
Psychedelic clinics operate at the intersection of DEA scheduling, FDA trial conduct, state-specific therapy laws, and standard HIPAA. We treat compliance as a product surface, not an add-on.
- Every clinical change is signed, timestamped, and attributable.
- AI actions are logged distinctly from human actions, with the prompt and response preserved.
- Data residency and tenant isolation on request.
PHI segmentation, BAA on request, role-based access.
E-signatures, immutable audit trail, ALCOA+ alignment.
Source-data integrity, monitoring readiness, protocol fidelity.
Type II in progress. Current controls available under NDA.
Schedule I/III chain-of-custody and reconciliation workflows.
Configurable to Oregon Measure 109, Colorado NMHA, and trial-site rules.
Plays nicely with the tools you already trust
From kickoff to live in days
Discovery
We map your modalities, protocols, and current toolchain. You get a written gap analysis.
Configuration
We model your SOPs, intake forms, protocol library, and roles in VistaraOS. Your team validates.
Pilot
One service line goes live with white-glove support. AI Operator runs in shadow mode first.
Full rollout
Remaining service lines migrate. Old tools deprecate on a schedule you control.
One platform, every shape of psychedelic medicine
Ketamine clinics
Solo practices to multi-site networks. IM, IV, and at-home oral protocols. Insurance and self-pay.
Psilocybin service centers
Oregon Measure 109 and Colorado NMHA-licensed centers. Facilitator scheduling, dosing-room ops, integration.
Sponsored trial sites
Phase II and III investigators for MDMA, psilocybin, ibogaine, 5-MeO-DMT. eCRF, eConsent, monitoring.
Academic & research
University departments and research foundations running IRB-approved studies. Multi-arm, multi-site.
Questions we hear every demo
Are you an EHR replacement?+
Yes — for psychedelic-medicine workflows. We replace the generic EHR for clinical documentation, scheduling, and patient records, and we add the trial, compliance, and modality-specific layers a generic EHR cannot.
How is patient data protected?+
PHI is encrypted at rest (AES-256) and in transit (TLS 1.2+). Access is role-based, audited, and logged. BAAs are signed before any production data is shared.
Where does AI fit in clinical decision-making?+
AI Operator drafts, suggests, and watches — it does not prescribe. Every clinical decision remains with a licensed clinician, and every AI suggestion is logged with its inputs for review.
Can we use VistaraOS for a single trial?+
Yes. Many sites start with a single sponsored trial and expand into commercial care. Pricing scales with volume, not seat count.
What does pricing look like?+
Annual platform fee plus a per-patient-encounter component. We size the proposal to your actual volume after the discovery week. No per-seat pricing.
How do you handle controlled substances?+
Built-in DEA-aligned chain-of-custody: receiving, vault transfers, dose preparation, administration, wastage, and reconciliation. Discrepancies trigger an alert and a closed-loop workflow.
Run your clinic on one platform.
Twenty minutes. We'll show you the actual product, your actual workflows, and what your first 90 days would look like.