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CNS, Psychiatry & Neurology

Psychiatric and neurologic trials from first-in-human (FIH) through Phase 1b and proof-of-concept (PoC) studies, across multiple indications and the full range of central nervous system (CNS) assessments. Backed by 25+ years of early phase experience and a neuroscience team that has contributed to numerous successful New Drug Applications.

Discuss your CNS trial
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CNS trials conducted by our Investigators

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Years of CNS, psychiatry & neurology experience

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CNS publications & presentations

Indications and study types

Indications

Substance Use Disorders & Addiction

Depression (TRD, MDD)

Bipolar Disorder

Schizophrenia

ADHD (Adult, Pediatric)

Epilepsy

Alzheimer’s Disease/Dementia

Parkinson’s Disease

Study types

First-in-Human (FIH):
NDA-enabling clinical pharmacology studies:

Human Abuse Potential (HAP)/Human Abuse Liability (HAL)

Phase Ib/IIa Proof-of-Concept (POC)

Phase I-III multicenter trials

CNS assessments

CNS trials are defined by a combination of specialized procedures and clinical assessments. Successful execution requires experienced staff, standardized processes and consistent data collection across multiple endpoints. Our team has operational expertise with a wide range of CNS-specific procedures and assessments across both healthy volunteer and patient populations.

Our team has expertise with the following CNS-specific procedures and rating instruments:

  • Visual Analog Scales (VAS)
  • Cerebrospinal fluid (CSF) sampling 
  • Electroencephalogram (EEG)
  • Clinician-Administered Dissociative States Scale (CADSS)
  • Brief Psychiatric Rating Scale (BPRS)
  • Modified Observer’s Assessment of Alertness/Sedation Scale (MOAA/S)
  • Hamilton Depression Rating Scale (HAM-D)
  • Montgomery-Åsberg Depression Rating Scale (MADRS)
  • Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
  • ADHD Rating Scale (ADHD-RS)
  • Clinical Global Impressions (CGI)
  • Patient Health Questionnaire-9 (PHQ-9)
  • Columbia-Suicide Severity Rating Scale (C-SSRS)

CNS infrastructure and partnerships

Dr Hull speaking with a peer

Clinical pharmacology unit

Our physician-led clinical pharmacology unit supports CNS studies requiring inpatient stays, intensive PK sampling, continuous safety monitoring and complex multi-period designs, so studies with demanding monitoring or dosing requirements can be executed in a controlled environment. The unit accommodates both healthy volunteer and patient cohorts.

Multicenter trials

For multicenter patient trials, we draw on an established network of strategic site partners with documented experience enrolling neurological, psychiatric and neurodegenerative populations. Site selection and ongoing oversight are managed by our Site Partnerships Team, with criteria aligned to investigator experience, enrollment performance and data quality standards, helping sponsors achieve consistent execution across participating sites. 

Through our Lead Site Model, we can serve as both the CRO and the first enrolling clinical research unit, providing firsthand operational insight that helps strengthen protocol compliance, improve feasibility and identify potential challenges before they impact study conduct. This approach supports faster site readiness, streamlined communication between sponsors and sites and delivers consistent execution across the study lifecycle.

Lab team at work in the research lab

Central lab

Our Central Laboratory supports multicenter studies with laboratory manual development, kit production, site supply logistics and standardized specimen management. Centralized laboratory data and real-time access to results helps improve data consistency across sites, supports safety oversight and streamlines study execution from startup through final reporting.

PK processing &
safety laboratory 

Our CLIA-certified PK Processing & Safety Laboratory provides on-site safety testing, endpoint sample processing and real-time access to laboratory results. Integrated technology and barcode-enabled workflows support efficient study execution, data quality and timely study decisions.

Dr vince clinical research laboratory employee

Pharmacy services

Study drug is prepared and stored on-site in our 2,500 sq. ft. cGMP-compliant pharmacy, which is DEA-registered to handle and store Schedule I-V controlled substances. The pharmacy is equipped to prepare investigational products across multiple routes of administration, including injectable formulations, nasal insufflation, powder-in-capsule, powder-in-solution and over-encapsulation. Integration within our Phase I unit enables rapid delivery of prepared doses under controlled conditions, reducing the number of handoffs, maintaining chain of custody and delivering on-time dosing.

Technology and data visibility 

Our fully integrated technology platform, including eSource, EDC and CTMS, along with AI-driven tools help streamline data collection throughout the study. These secure, cloud-based systems provide real-time data visibility, validated audit trails, data integration and scalable access to reliable, high-quality data across the entire study lifecycle.

Our CNS leadership

Backed by scientific and clinical expertise in psychiatry and neurology, the same operational team supports your study from startup through closeout. Sponsors have direct access to the experts guiding their program throughout execution. 

Bradley Vince, DO

CEO & Chief Medical Officer

25 years of experience

Sheldon Preskorn, MD

Senior Vice President, Neuroscience

50 years of experience

Peter Schmidt, PhD

Chief Scientific Officer

31 years of experience

Korey Nevitt

Executive Director, Site Partnerships

25+ years of experience

Rose Gerringer

Ratings Manager

14 years of experience

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Featured study

Challenge

The study required enrollment of adolescents with psychiatric disorders, a specialized population that presented unique challenges related to participant identification, caregiver engagement and retention during extended inpatient stays. The trial also required operational adaptations to support the needs of younger participants while ensuring compliance and participant safety.

Approach

We implemented a targeted recruitment strategy focused on participant outreach, caregiver engagement and streamlined pre-screening procedures. Our team also adapted the study environment and operational plan to better support adolescent participants, creating a more comfortable experience while maintaining study requirements and oversight.

Outcome

We successfully screened and enrolled participants, exceeding our site’s original enrollment goal and becoming a top-enrolling site in the study. The successful execution demonstrated our ability to recruit, engage and retain specialized CNS populations while delivering high-quality operational support throughout study conduct.

Related resources

Considering DVCR for your CNS study? 

Talk to a team that has extensive CNS study experience. 

Together, we will discuss your protocol, required CNS assessments and most importantly, your study timeline to determine the best path forward. From the first conversation, the clinical and scientific experts responsible for your study are actively involved, ensuring  potential issues are identified early and discussed directly.

Request a Capabilities Meeting Download CNS capabilities sheet