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| CENTER
OVERVIEW |
| Apex Research Institute (ARI) is an independent, dedicated clinical research site specializing in providing Phase II, III, and IV clinical research services for the pharmaceutical, nutritional, and medical device industries.
Founded in 1984, ARI has expanded from strictly Cardiology studies to conducting over 400 national and international clinical trials in the therapeutic areas of: |
- Cardiology/Cardiac Surgery
- Endocrinology
- Gastrointroenterology
- Geriatrics
- GI
- Hypertension
- Immunology
- Insomnia
- Musculoskeletal & Connective Disorders
- Neurology
- Nutrition
- Pain Management
- Psychiatry
- Pulmonary/Critical Care
- Radiology
- Smoking Cessation
- Urology/Nephrology
- Vascular/Cardiovascular Disorders
- Women's Health
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| ARI
FACTS |
- ARI's physical plant is a 3,500 square foot clinical facility which includes 6 exam rooms, a locked pharmacy, a conference room, and dedicated monitoring space
- The center maintains a computerized IT network Patient Tracking System
- ARI staff conducts monthly Coordinator meetings to discuss protocol issues, patient enrollment, and to monitor comments for internal Quality Assurance
- ARI's dedicated staff is bilingual in both English and Spanish
- The center has a strong affiliation and 20 years history with many pharmaceutical companies, including: AstraZeneca, Aura, Aventis, Berlex, Boehringer Ingelheim, Bristol Myers Squibb, CV Therapeutics, Eli Lilly, Generex, GlaxoSmithKline, Merck, MSD, Novo Nordisk, Otsuka, Pfizer, Parke Davis, Pharmacia Upjohn, Reliant, Sankyo, Sanofi, Schering Plough, Searle, Takeda, United Therapeutics, Wyeth Ayerst
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| MEDICAL
MANAGEMENT |
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Cathy Fox, BS Chief Operating Officer
Cathy holds a Bachelor of Science in Exercise Physiology and has been involved in clinical research since 1984. Prior to being COO, Cathy was both a study coordinator and a monitor. |
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| AFFILIATIONS |
- ARI maintains a strong affiliation with many local private practices as well as local clinics catering to the minority, especially Hispanic, patient population
- ARI works closely with Western Medical Center, Santa Ana for in-patient trial needs and recruitment
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| PATIENT
DEMOGRAPHICS |
- ARI is located within Orange County, California and conveniently situated next to the Western Medical Center, Santa Ana, 15 minutes from the John Wayne Airport and only minutes from the 5, 22, and 55 freeways
- Orange County's population consists of:
51% Caucasian 31% Hispanic |
- ARI maintains a centralized database of over 3,500 research volunteers along with having access to databases of over 40,000 patients from three private practices
- Although ARI's centralized database is predominately a Caucasian patient population, its affiliation with local Hispanic clinics provides access to the large minority community of Orange County
- Patient recruitment is achieved by:
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- ARI employs a full-time marketing/recruitor who utilizes: - Trait searches via clinic databases - Physician referrals - Public relations and marketing efforts (i.e. local health fairs, advertising, education seminars, etc.) |
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| STAFF |
- Multi-therapeutic Investigators experienced in the areas of: Cardiology, Diabetes, GI, Hyperlipidemia, Insomnia, Neuropsychology, and Women's Health.
- 7 Clinical Research Coordinators (4 are CCRC certified)
- Quality Assurance Manager
- Clinical Research Coordinator Assistant
- Patient Recruitment Specialist
- Information Technology Specialist
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| EDUCATIONAL
PROGRAMS/CERTIFICATIONS |
- FAA certified staff for the shipment of hazardous materials
- Comprehensive SOPs (Standard Operating Procedures)
- ACRP training for all coordinating staff
- CLIA certified laboratory
- Local health fairs and educational seminars
- Bi-monthly newsletter sent to current and past research volunteers
- Certified Smoking Cessation Counselors
- HIPAA trained/certified staff in research guidelines
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| DIAGNOSTIC/CLINIC
EQUIPMENT |
- Centrifuge
- Echocardiography
- Electrocardiogram
- Treadmill Exercise Testing with V.02
- Freezer (-20°C)
- Locked Pharmacy
- Refrigerated Centrifuge
- Limited on site laboratory
- Pulmonary Function Testing
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| | ARI also has access to the following equipment within walking distance: |
- DEXA
- Mammography
- Nuclear Medicine
- Radiology
- X-Ray
- Full Service Hospital with Trauma Center
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2005 AMR, LLC
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