Early phase clinical research, including special population and adaptive trials are conducted at our upscale clinical pharmacology unit. Successful recruitment of healthy normal subjects and intent–to-treat populations is ensured secondary to our extensive therapeutic area database and experience gained from later stage studies conducted over the last decade. The upscale, purpose-built research campus is highlighted as a “Center of Research Excellence” with a tradition of rapid study start-up, successful subject recruitment and superior data quality.

On average, our dedicated full-time experienced Principal Investigators have participated in approximately 200 clinical trials each, alongside our team of > 50 clinical research professionals.

• 80-bed secure upscale facility
• First-in-Human (FIH) unit equipped with telemetry for intense cardiac monitoring
• Configurable, separate male and female wards
• Pharmacy and drug storage: Secure, temperature-controlled drug storage, dispensing and preparation pharmacy
• On-site extemporaneous drug preparation room with negative pressure
• Menus designed by Registered Dieticians and catered meals prepared to protocol specifications
• Courtesy telephones, private lockers and laundry facilities for personal belongings
• Push-button emergency devices in bathrooms and dorm rooms
• Catered menus prepared to protocol specifications
• Central IRB site or Local IRB utilization

• Closed-circuit TV and secure key code access
• Central Monitoring Station for 24-hour subject observation
• Push-button emergency devices in bathrooms and dorm rooms
• Back-up generator

• Extensive subject entertainment facilities: plasma televisions, theater room with movie style seating, full arcade, and computer/Internet area
• Courtesy telephones, private lockers and laundry facilities for personal belongings
• Private bathrooms and shower facilities, ensuring subject retention

Study Types Intent-to-Treat populations: Proof of Concept Drug Interaction Drug Metabolism Bioavailability Bioequivalence Dose-ranging and Tolerability Pharmacokinetic Pharmacodynamic Cardiac Safety First in Human ACLS Certified Paramedics and Physicians on staff	Therapeutic Areas CNS Psychiatry Vaccines Pulmonary Addiction Metabolic Pain Dermatology Sleep
Populations Psychiatry Sleep Disorders Pediatric Adolescent Elderly Obesity Diabetes Dermatology Women’s Studies Others upon Request	Administration Routes IV, IM and Subcutaneous Injection Inhaled Intranasal Oral, Sublingual Ophthalmic Buccal Topical Transdermal Suppository

Vince and Associates provides full support options including:

• Project Management
• Medical Writing
• Monitoring
• Data Management
• Biostatistics
• PK Analysis

Please contact Dr. Lorraine M. Rusch at LRusch@vinceandassociates.com or 914-548-1690.