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Psychedelics
The CRO
for Psychedelics
CRC is a CNS-focused psychedelic clinical trial CRO helping sponsors navigate complex regulatory pathways, specialized site requirements, facilitator and rater training needs, and endpoint reliability risks.
Through an integrated CNS delivery model, our team aligns psychedelic trial strategy with practical execution services, including protocol development, site selection, Schedule I planning, dose session procedures, facilitator and rater training, safety oversight, endpoint reliability, and placebo response mitigation.
With 10 psychedelic studies supported and expertise that includes members of the ISCTM Psychedelics Working Group, CRC helps sponsors move from study concept to execution with greater clarity, stronger planning, and minimized risks.
CRC supports sponsors advancing psychedelic and neuroplastogen assets across a range of compounds and mechanisms, including:
- DMT
- LSD
- Psilocin
- Psilocybin
- Ketamine
- MDMA
- Neuroplastogen IPs
Each asset brings different considerations for study design, dosing procedures, safety monitoring, participant preparation, endpoint selection, and data interpretation. CRC works with sponsors to tailor the study model to the asset, indication, phase, risk profile, and development goals.
Strategic Design
and Execution Support
CRC supports psychedelic clinical trials through targeted, study-specific strategies that account for the unique operational and scientific demands of psychedelic research.
CRC’s psychedelic clinical trial support may include:
- Synopsis and protocol development in accordance with FDA guidance
- Schedule I licensure support
- Investigational product management planning
- Placebo mitigation strategy
- Risk and safety mitigation planning
- Patient education manual development
- Dose session monitor / facilitator treatment manual and training
- Rater qualification, training, certification, and surveillance
- Abuse potential assessment
- Endpoint selection and assessment strategy
- Site readiness and infrastructure evaluation
- Vendor and specialty procedure coordination
CRC’s approach is designed to help sponsors anticipate study risks early, align stakeholders around clear operational expectations, and support high-quality data collection from startup through study completion.
Specialized Site Partnerships
for Psychedelic Studies
Site selection can determine whether a psychedelic study is truly executable. CRC works with leading psychedelic sites and experienced CNS research partners to support studies that require specialized infrastructure, trained personnel, and careful coordination across dosing, assessments, and participant safety.
CRC’s site partnership approach may include evaluation of:
- Diverse patient enrollment capabilities
- Psychedelic-assisted facilitation certification
- State-of-the-art dosing rooms
- Schedule I licenses
- Harmonized SOPs
- Imaging capabilities
- EEG/ERP for dose-response
- PD biomarker analysis
- Endpoint execution experience
- Participant safety and support processes
- Recruitment feasibility
- Startup readiness
These partnerships help sponsors move beyond theoretical feasibility and toward practical execution plans grounded in site-level insight.
PROTECTING ENDPOINT
RELIABILITY IN
PSYCHEDELIC TRIALS
Rater Services for Psychedelic Clinical Trials
Psychedelic trials can be especially vulnerable to expectation effects, functional unblinding, participant bias, rater variability, and inconsistent site communication. CRC’s assessment expertise is integrated into the study model early to help protect endpoint reliability.
CRC’s approach may include rater training, rater certification, algorithmic rater and data surveillance, central review of assessments, ongoing feedback, remediation, and refresher training. These strategies help reduce variability and support consistent endpoint administration across sites.
Placebo Mitigation and Expectation Management
Placebo response can be a major challenge in psychedelic clinical trials. Participant expectations, site communication, dosing session dynamics, and subjective endpoints can all affect how participants report symptoms, improvement, or adverse events.
CRC supports sponsors in building placebo mitigation into the trial strategy from the beginning. This may include neutral communication training, participant-facing material review, eligibility review considerations, rater training, rater surveillance, and cross-functional data review.
Navigating Psychedelic Trials?
From protocol strategy to site readiness, facilitator training, rater oversight, Schedule I planning, and placebo mitigation, CRC helps sponsors navigate the specialized demands of psychedelic clinical trials with confidence.
Specialized Early-Phase
and Endpoint Capabilities
Many psychedelic programs require early-phase infrastructure, specialty procedures, or biomarker tools that go beyond standard clinical trial execution. CRC’s strategic partnerships support turnkey solutions designed for complex CNS research.
Capabilities may include:
- First-in-human medical risk identification and mitigation
- Diverse established databases
- Certified OR / surgical unit capabilities
- Pain modeling
- Schedule I licenses
- Neuroimaging
- Electrophysiology
- CSF and serial CSF
- Combined scientific consultation
- Translational medicine SME support
- Recruitment dependability
- Budget predictability
- Rapid startup
- MSA efficiencies
- Central IRB support
These capabilities help sponsors build studies that are scientifically rigorous, operationally practical, and aligned with key development milestones.
When Psychedelic Trial
Support Is Most Valuable
CRC’s psychedelic clinical trial support is especially valuable for sponsors navigating complex dosing procedures, Schedule I operational requirements, rater-dependent endpoints, participant expectation effects, site infrastructure needs, or specialized biomarker strategies.
This support may be particularly valuable when a study includes:
- Psychedelic-assisted therapy or facilitation
- Schedule I investigational products
- Subjective psychiatric endpoints
- Placebo response concerns
- Specialized dosing environments
- Complex participant education requirements
- Functional unblinding risk
- Biomarker or imaging components
- Abuse potential assessment
- Early phase safety, PK, or PD objectives
CRC helps sponsors bring these pieces together through an integrated CNS model that connects scientific leadership, clinical operations, assessments, medical oversight, biometrics, and site partnerships.
Evaluating Driving Safety or
Next-Day Impairment?
For psychedelic and CNS assets where next-day effects, psychomotor performance, sedation, cognition, or driving safety may be part of the development strategy, CRC’s Driving Studies solution supports standardized assessment of drug-related impairment through validated driving simulation methodology.
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