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Psychedelics Research Solutions​

Advancing novel therapeutics through scientific rigor​

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The Psychedelics Research Challenge​ 

Psychedelic compounds represent a promising frontier in treating depression, PTSD, anxiety, and other serious mental health conditions. Yet their unique pharmacological properties create unprecedented methodological challenges that can undermine trial integrity and regulatory acceptance.​

Unlike conventional CNS therapeutics, psychedelics produce distinct subjective experiences that make traditional blinding approaches insufficient. Combined with heightened patient expectations, sponsors face a critical question: How do you maintain rigorous blinding when the drug's effects are inherently recognizable?

What makes psychedelics different​

The Blinding Dilemma

​Patients and raters often recognize psychedelic effects, creating functional unblinding that can bias outcome assessments and inflate or mask true treatment signals.

Expectation Effects​

Strong preconceptions about psychedelic experiences can amplify placebo responses, making it difficult to isolate pharmacological effects from psychological expectations.

Rating Complexity​

Inconsistent ratings across sites due to varying rater experience with psychedelic patient presentations can compromise endpoint reliability and signal detection.

Patient Selection Complexity​

Determining appropriate study candidates requires multifactorial assessment beyond standard inclusion/exclusion criteria – from prior treatment response patterns to potential for meaningful therapeutic engagement.

Data Quality Requirements

​With close regulatory scrutiny, even minor inconsistencies in scale administration or scoring can raise questions about endpoint reliability.

Powering signal detection in psychedelics trials​

Signant Health has supported 35+ psychedelics trials across multiple indications, through a comprehensive suite of solutions and services precisely tailored to the methodological demands of psychedelics research while maintaining the scientific rigor regulators require.

Our solutions span from protocol design through reliable endpoint data collection:​

Strategic Planning

From protocol design through site selection, ensuring your study is built on proven methodologies and sites capable of delivering quality data in psychedelics research.​

Specialized Training

Goes beyond standard rater certification to address functional unblinding management, placebo response mitigation, and the nuances of assessing patients undergoing psychedelic experiences.

Purpose-Built Technology

Through Rater Station®, our eCOA platform designed specifically for complex clinician ratings, with support for both site-based and remote central rater administration of psychedelics-specific clinician ratings.

Independent Quality Oversight

By expert central review of video recorded assessment interviews, and our Pure Signal Analytics solution, identifying and mitigating data quality risks in real-time before they impact your study outcomes.​

Graphic - Psychedelic Brochure (1)

Scientific excellence: our defining differentiator​

What sets Signant apart in psychedelics research isn't just our experience – it’s the depth of clinical and scientific expertise we bring to every engagement.

CNS Expertise

Deep CNS Expertise​

Our science and medicine team includes renowned experts and key opinion leaders in mood disorders, PTSD, anxiety, OCD, and other indications where psychedelics show promise. We don't just understand scales and assessments, we understand the nuances of clinical assessment in psychedelics studies.

Regulations

Regulatory Intelligence​

We stay current with evolving regulatory guidance specific to psychedelics research, ensuring your trial design reflects both current standards and anticipated regulatory expectations.

 

Proven

Proven Methodologies​

Our specialized approaches to managing functional unblinding, mitigating placebo response, and ensuring rater consistency aren't theoretical, they're battle-tested across dozens of psychedelics trials and have contributed to successful regulatory submissions.

Monitoring

Innovation in Quality Monitoring​

PureSignal Analytics, delivered through our proprietary algorithms and in-house clinicians and data scientists, represents a fundamentally different approach to data quality – moving beyond reactive monitoring to proactive risk identification with targeted clinical interventions that drive continuous improvement throughout your study.​

Evidence

Evidence-Based Training 

Our rater training programs demonstrate measurable impact: significant increases in signal-to-noise ratio through reduced variability, with marked improvements in rater performance even among highly experienced psychiatric investigators.

The Complete Package: Solution, Science, Service, Scale

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SOLUTION

Comprehensive clinical data capture technology purpose-built for the complexity of CNS endpoints, with specialized capabilities for psychedelics research including remote central rating, psychedelics-specific patient-reported outcomes, and diagnostic validation processes.

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SCIENCE

Unparalleled scientific expertise and active participation with the evolving regulatory landscape, ensuring your trials are conducted with methodological rigor that withstands regulatory scrutiny.

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SERVICE

Mature operational processes and experienced teams who understand the unique logistical demands of psychedelics trials – from managing complex assessments to coordinating remote and on-site rating workflows.

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SCALE

Global reach with capacity to support trials from early phase through pivotal registration studies, backed by enterprise-grade security and compliance infrastructure.


Experience Counts​

The psychedelics field is evolving rapidly. Regulatory expectations are evolving. Trial methodologies that worked for conventional psychiatry may not translate directly to psychedelic research. ​

​With 35+ psychedelics trials delivered across multiple disease indications and development phases, Signant has accumulated hard-won knowledge about what works, and what doesn’t, in generating regulatory-grade evidence for this novel therapeutic class.​

​This experience translates directly into reduced risk for your program.

Partner With Purpose

Whether you're initiating your first psychedelics trial or advancing a late-stage program toward approval, Signant provides the specialized expertise to help you generate the quality evidence needed to bring these promising therapies to patients.

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