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Clarity for Complex Neuropsychiatric Development

Neuropsychiatric Drug Development

Neuropsychiatric drug development is complex, high-risk, and heavily scrutinized by regulators. With deep expertise in both psychiatric and neurological indications, including emerging psychedelic therapies, we provide end-to-end support, from strategic trial design and regulatory guidance to our specialized site network, global rater training, and rigorous data quality oversight. Our proven track record in reducing placebo response, standardizing subjective endpoints, and overcoming recruitment challenges ensures that every study is executed with scientific rigor and operational efficiency.

Key Challenges Addressed:

  • Placebo Response
  • Population Variability
  • Subjective Endpoints
  • Recruitment Difficulty
  • Regulatory Uncertainty
  • Safety Monitoring
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Core Capabilities & Differentiators in Neuropsychiatric Clinical Research

Trial Design & Regulatory Strategy

(Preclinical → Phase III)
  • Regulatory pathway consulting (FDA/EMA)
  • Endpoint selection (clinician-rated, patient-reported, digital biomarkers)
  • Scale selection and validation (HAM-D, PANSS, MADRS, CGI, etc.)
  • Adaptive design and enrichment strategies

Site & Investigator Network

(Phase I → Phase III)
  • Global access to CNS-specialized sites, including ERG’s experienced neuropsychiatric sites and principal investigators
  • Sites and personnel are trained on complex assessments and consistent inter-rater reliability with our proprietary Unified Site Methodology.
  • Patient population availability (MDD, schizophrenia, bipolar, ADHD, Alzheimer’s, rare CNS)

Rater Training & Certification

(Phase I → Phase III)
  • Standardized global rater training
  • Inter-rater and intra-rater reliability checks
  • Ongoing calibration sessions across sites
  • Proprietary placebo response mitigation training for both participants and site staff
  • In study rater surveillance
  • Centralized rating capabilities

Patient Recruitment & Retention

(Phase II → Phase III)
  • Pre-screened patient databases
  • Digital outreach & advocacy group partnerships
  • Retention programs (transportation, engagement, flexible scheduling)

Data Quality & Compliance

(All Phases)
  • Participant eligibility reviews and adjudication
  • Centralized data monitoring
  • Neuroimaging, EEG, wearables, ePRO management
  • Regular endpoint review to detect trends and/or outliers
  • HIPAA/GDPR compliance for sensitive data

Specialized Facilities & Logistics

(Phase I → Phase III)
  • Inpatient units and controlled environments (e.g., post-operative pain in neurological surgery, sleep studies, or psychiatric inpatients)
  • DEA-compliant storage for controlled substances
  • 24/7 medical coverage

Your Choice CRO for Neuropsychiatric Drug Development

Lotus Clinical Research is the trusted CRO partner for Sponsors navigating the complexities of neuropsychiatric drug development. Whether you’re advancing a novel mechanism or optimizing an existing therapy, Lotus offers the insight, infrastructure, and global reach to bring your neuropsychiatric program from concept to approval with confidence.

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