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| CENTER
OVERVIEW |
| Clinical Research Associates of Tidewater (CRAT) is an independently owned dedicated clinical research site specializing in providing Phase II, III, IV, and RX-to-OTC clinical research services for the pharmaceutical, nutritional, and medical device industries.
Established in 1983, CRAT has conducted over 450 national and multinational clinical trials in the therapeutic areas of:
- Allergies & Sinus
- Anemia
- Angina
- Anxiety
- Arthritis
- Asthma
- Atrial Fibrillation
- Cholesterol/Hyperlipidemia/Mixed Dyslipidemia/Dyslipidemia
- Chronic Kidney Disease
- Chronic Pain
- Coronary Heart Disease
- Depression
- Dermatology
- Diabetes
- Dialysis
- End Stage Renal Disease
- Gastrointestinal Reflux Disease (GERD)
- Geriatrics
- Hereditary Angioedema (HAE)
- High Blood Pressure/Hypertension
- Indigestion/Dyspepsia
- Irritable Bowel
- Migraines
- Obesity
- Orthopedics
- Osteoporosis
- Pediatrics
- Podiatry
- Pulmonary Disease
- Renal Transplantation
- Sexual Dysfunction
- Sleep Disorders
- Smoking/Smoking Cessation
- Stress Incontinence
- Urinary Tract Infection
- Vaccines
- Women's Health
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| CRA
of Tidewater FACTS |
- CRAT has a 5,000 plus square foot clinical facility
- Conveniently located on the campus of Eastern Virginia Medical School
- The Tidewater area is easily accessed by the Norfolk International Airport
- Passed FDA audit with zero deficiencies for a four year clinical trial with a large subject population
- Maintains a computerized patient tracking system
- Fluent with RDE (remote data entry)
- Fluent with internet data entry
- Fully compliant with Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Site not under jurisdiction of the local IRB and is able to utilize central IRB services
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| MEDICAL
MANAGEMENT |
Duane G. Wombolt, MD, FACP
President
Dr. Wombolt is board certified in Internal Medicine and Nephrology, is a Professor of Medicine at Eastern Virginia Medical School and is a Certified Physician Investigator (CPI). Dr. Wombolt is a lecturer and serves on boards of advisors for numerous continuing medical educational programs sponsored by the nation's leading pharmaceutical manufacturers. Dr. Wombolt has also been conducting various phases of research since 1974.
Patient Demographics:
The Hampton Roads/Tidewater area is the 27th largest metropolitan market in the United States and boast a diverse population of over 1.6 million people.
Gender distribution: Males 52%
Females 48%
Patient Recruitment:
- Physician Referrals
- Repeat study participants
- Health fairs
- Educational seminars
- Health Screenings
- Advertising (television, radio, newspaper, direct mailings)
- Secured subject data base over 4,000 subjects. Database maintained by Clinasyst
- Designated patient recruiter
- Full time marketing coordinator
- 24-hour study hotline
- Website
- Special events
- Quarterly newsletter
- Wellness partnerships with area businesses
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| STAFF |
- Extensive network of multi-therapeutic investigators with practices in: Allergy, Cardiology, Dermatology, Endocrinology, Gastroenterology, Gynecology, Immunology, Internal Medicine, Nephrology, Orthopedics, Pediatrics and Podiatry
- Four certified nurse practitioners
- Certified diabetic educator
- Registered dietician
- Combined clinical research experience of over 73 years
- Administrative/Office staff includes Director of Business Operations, Director of Clinical Operations, Full Time Recruiter/Regulatory Affairs Manager
- Eight full time Clinical Research Coordinators, one full-time Medical Assistant, one full-time Marketing Coordinator
- Eligible coordinators are ACRP certified
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| EDUCATIONAL
PROGRAMS/CERTIFICATIONS |
- American Heart Association Certification for Standards and Techniques of Blood Pressure Measurements
- IATA certified staff for the shipment of hazardous materials
- Comprehensive SOPs
- CLIA waived laboratory
- Certified Physician Investigator (CPI)
- Certified Smoke Cessation Coordinators
- All staff CPR certified
- NIH certified staff
- NIH Federalwide Assurance
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| DIAGNOSTIC/CLINIC
EQUIPMENT |
- Ambulatory B/P & Holter Monitoring
- Locked Freezers (-20°C and -80°C)
- Climate Controlled/ locked drug storage
- Refrigerated centrifuge/laboratory equipment
- Locked limited access medical records room
- ECG Machines
- Blood Pressure Monitors
- Glucometers
- Electronic Cholesterol Meters
- Natural gas generator to maintain freezer and refrigerator temperatures in event of power outage
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| CRAT also has access to the following equipment: |
- EEG
- MRI
- X-ray
- GI Procedures
- DEXA scanner
- Mammography
- Cardio stress testing
- Radiology
- 12 Bed Sleep Lab
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2005 AMR, LLC
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