HAP/HAL studies require structured, disciplined execution
DVCR supports human abuse potential/liability studies with experienced scientific oversight, in-house VAS raters, controlled substance pharmacy capabilities, targeted recruitment and technology-enabled endpoint capture.
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Designed for the operational demands of HAP/HAL research
Human abuse potential studies require more than standard early phase execution. DVCR helps sponsors manage recreational drug-user recruitment, qualification-phase assessment, subjective endpoint quality, controlled substance handling and safety oversight within a Phase I unit designed for complex abuse liability studies.
HAP/HAL study experience
Investigator and scientific team involvement in more than 75 HAP studies, including government-funded projects.
In-house VAS raters
Dedicated raters and a full-time Ratings Manager support participant training, protocol review, staff oversight and subjective endpoint quality.
Controlled substance pharmacy support
Pharmacy team supports over-encapsulation, blinding, accurate dosing and handling across multiple drug classes and routes of administration.
Purpose-built Phase I infrastructure
A 100-bed Phase I unit with dedicated pupillometry rooms, video surveillance and crash carts supports controlled study conduct.
Targeted volunteer recruitment
An active database of substance users with experience across drug classes supports recruitment for qualification and treatment phases.
Technology-enabled data quality
Cambridge Cognition CTIS-AL supports configurable VAS, paperless administration, immediate data storage, real-time access and electronic schedule management.
Pharmacy capabilities for abuse liability study conduct
HAP/HAL studies often require careful preparation, blinding and handling of investigational products, positive controls and scheduled drugs. DVCR’s cGMP pharmacy supports controlled substance study execution with experience across medication classes, routes of administration and blinding requirements.
Key capabilities include:
- 50+ years of combined pharmacy research experience
- Pharmacy team supports over-encapsulation, blinding, accurate dosing and handling across multiple drug classes and routes of administration
- Experience with opioids, stimulants, hallucinogens, hypnotics, depressants, sedatives, dissociatives and cannabinoids
- Over-encapsulation and blinding of investigational products
- Injectable formulations, including IV and IM
- Nasal insufflation
- Powder-in-capsule preparation
- USP 795 compliant non-sterile compounding room
- Analytical balance housed within a HEPA-filtered enclosure for API powder weighing
