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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
500 national and international clinical trials in the therapeutic areas of: |
- Acute Myocardial Infraction
- Alzheimer's
- Angina
- Anxiety
- Arrythmia
- Arthritus
- BPH
- Breast Cancer Screening
- Claudication
- Cardiology/Cardiac Surgery
- Coronary Artery Disease
- Depression
- Dermatology
- Diabetes
- Electrophysiology Studies
- Erectile Dysfunction
- Endocrinology
- Fibroymalgia
- Gastrointroenterology
- Geriatrics
- GI
- Headache/Migraine
- Hypertension
- Immunology
- Insomnia
- Musculoskeletal & Connective Disorders
- Neurology
- Nutrition
- Obesity
- Oral Contraceptive
- Osteoarthritis
- Osteoporosis
- Pain Management
- Pediatrics
- Pneumonia
- Psychiatry
- Pulmonary/Critical Care
- Radiology
- Smoking Cessation
- Urology/Nephrology
- Vascular/Cardiovascular Disorders
- Vaccines
- 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 patient database
- 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 speaking both English and Spanish
- The center has a strong affiliation and 20 years history with many pharmaceutical companies, including:
- Abbott
- Active Biotics
- Allegan
- Andrx Labs
- AstraZeneca
- Aura
- Aventis
- Bayer
- Berlex
- BioMarin
- Boehringer Ingelheim
- Bristol Myers Squibb
- Colorado Prevention Center
- CV Therapeutics
- Daiichi-Sankyo
- Dura Med
- Eisai
- Eli Lilly
- Forest Pharmaceuticals
- Generex
- Gilead
- GlaxoSmithKline
- Hoffman LaRoche
- Isis
- Jazz
- KOS
- Merck
- Novartis
- Novo Nordisk
- Ono Pharma
- Orexigen
- Otsuka
- Pfizer
- Parke Davis
- Pharmacia Upjohn
- Pliva
- Reliant
- Sanofi-Aventis
- Schering-Plough
- Schwarz
- Searle
- Takeda
- TAP
- United Therapeutics
- Valentis
- Wyeth Ayerst
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| MEDICAL
MANAGEMENT |
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Cathy Fox, BS
Executive Officer
Cathy holds a BS in Exercise Physiology, MPH in progress and has been involved in clinical research since 1984. She is co-founder of Apex Research Institute and has conducted over 500 clinical trials.
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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 the Hispanic patient population
- ARI works closely with Western Medical Center, Santa Ana for in-patient trial needs and recruitment
- WBENC, NFA, and Alzheimer's Association (Orange County Chaper)
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| PATIENT
DEMOGRAPHICS |
- ARI is located within Orange County, California and conveniently situated next to the Western Medical Center, Santa Ana. Located 15 minutes from the John Wayne Airport and only minutes from the 5, 22, and 55 freeways.
- The center maintains a database of over 11,000 research volunteers. The center also has access to databases of over 40,000 patients from three private practices. We have a diverse patient population including Caucasian, African-American, Hispanic, Asian, Native American and many other nationalities.
- Patient recruitment is achieved by:
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- ARI employs a full-time marketing/recruiter 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.
- 5 Clinical Research Coordinators (One
as her PhD, One is a NP, 3 are CCRC certified)
- Director of Quality Assurance
- Director of Marketing and Recruitment
- Director of Regulatory
- Director of Business Development
- 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)
- Freezer (-70°C)
- Locked Pharmacy
- Refrigerated Centrifuge
- Limited on site laboratory
- Pulmonary Function Testing
- Information Systems: Including NT network throughout office with study
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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
- Ultrasound
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