Overview

Clinical Research Associates of Tidewater (CRAT) is an independently owned, dedicated clinical research site specializing in providing phase 2 to 4 and prescription to OTC clinical research services for the pharmaceutical, nutritional and medical device industries.

Research Experience

Established in 1983, CRAT has conducted more than 450 national and multinational clinical trials in the therapeutic areas of:

• Acne
• Allergies and sinus
• Anemia
• Anxiety
• Arthritis
• Asthma
• Atrial fibrillation
• Bioterrorism vaccines
• Cholesterol/hyperlipidemia/dyslipidemia/mixed dyslipidemia
• Chronic kidney disease
• Chronic pain
• Contraceptives
• Coronary heart disease
• Constipation
• Depression
• Diabetes
• Dialysis
• End-stage renal disease
• Erosive esophagitis
• Gastrointestinal reflux disease
• Gout
• Healthy volunteers
• Heart disease
• Hereditary angioedema
• High blood pressure (mild, moderate, severe)
• Indigestion/dyspepsia
• Insomnia
• Irritable bowel
• Migraines
• Obesity
• Orthopedics
• Osteoporosis
• Pediatrics
• Podiatry
• Postmenopausal symptoms
• Psoriasis
• Pulmonary disease
• Renal transplantation
• Rosacea
• Sexual dysfunction
• Smoking alternatives and devices
• Stress incontinence
• Tinea pedis/athlete’s foot
• Urinary tract infection
• Vaccines
• Women’s health

Facility Description

Conveniently located on the medical campus with a medical school, a heart hospital, a large tertiary hospital and a children’s hospital.

The Tidewater area is easily accessed by the Norfolk International Airport.

On-site:

• Dedicated outpatient study center in a 4,451-sq. ft. clinical facility
• Four exam rooms
• Large laboratory
• Conference room
• Dedicated monitoring area
• Locked regulatory document room
• Locked drug closets

• Belfont Micro Smokerlyzer breath carbon monoxide monitor
• Refrigerated and room-temperature centrifuges
• Freezers and refrigerators operate on a backup generator in the event of a power failure
• Norlake Scientific 52-cubic foot, locked refrigerator
• Locked freezers (-20° and -80° C)
• Climate-controlled, locked drug storage
• Ample storage for drug and sera samples
• Omano microscope
• Ambulatory B/P and Holter monitoring
• ECG machine
• Blood pressure monitor
• Pulmonology function testing
• Glucometers

All equipment is calibrated and serviced annually

CRAT also has access to the following equipment:

• EEG
• MRI
• GI procedures
• DEXA scanner
• X-ray
• Mammography
• Echocardiography
• Cardio stress testing
• Radiography
• Ultrasounds
• Endoscopy
• 12-bed sleep lab

Monitor Accommodations

• Our research facility has a spacious office area designated for monitors;
• Each office station is equipped with a telephone and internet port for laptop use;
• An additional office is also available for desired privacy and is equipped with a telephone and computer;
• Accessible copy and fax machine;
• Complimentary refreshments; and
• Hotel arrangements can be made at more than 25 locations that are less than 10 miles away from our facility.

Investigator Experience

Duane G. Wombolt, MD, FACP, CPI
President

Dr. Wombolt is board-certified in internal medicine and nephrology. He is a professor of medicine at Eastern Virginia Medical School and is a certified principal investigator. He has been conducting various phases of clinical research trials since 1974. He is a lecturer for numerous medical continuing education programs sponsored by the nation's leading pharmaceutical manufacturers. He recently retired as the founding and senior member of the first nephrology practice in the Tidewater area. Dr. Wombolt also founded and served as the medical director of both public and private dialysis facilities.

Staff Expertise

• Combined clinical research experience of more than 73 years
• Extensive network of multitherapeutic investigators with practices in:
  • Internal Medicine
  • Nephrology
  • Cardiology
  • Gastroenterology
  • Allergy
  • Immunology
  • Orthopedics
  • Endocrinology
  • Dermatology
  • Gynecology
  • Podiatry
  • Ophthalmology
  • Pediatrics
  • Psychiatry/psychology
• Principal investigator certified by the ACRP
• Three certified nurse practitioners
• Certified diabetic educator
• Registered dietician
• Five full-time certified CRCs
• Cross-trained to handle high volume trials
• Each trial is assigned a primary and secondary research coordinator
• Research coordinators’ certifications and training:
  • CRCs certified by the ACRP
  • American Heart Association certification for standards and techniques of blood pressure measurements
  • Educational training with CME Enterprise in smoking prevention and treatment
  • National Institutes of Health (NIH) training for protecting human research participants
  • Good clinical practices training in accordance with ICH guidelines
  • All staff members are CPR-certified
• Full-time recruiter
• Regulatory affairs manager
• Full-time marketing coordinator
• Dedicated data entry personnel
• Director of business operations
• Director of clinical operations
• Assistant director of clinical operations
• Two research assistants

Patient Demographics

The Hampton Roads/Tidewater area is the 27th largest metropolitan market in the United States. The area boasts a diverse population of more than 1.6 million people. There are six area colleges and universities within minutes from our facility. Norfolk, Va., is home to the world’s largest naval base. The Army, Air Force, Marine Corps and Coast Guard are in the region as well as the Port of Hampton Roads. The site's database contains more than 6,500 subjects who have expressed an interest in participating in clinical trials. Retention rates of 95 percent or greater.

Gender Distribution

• Males: 52 percent
• Females: 48 percent

Age Distribution:

• Under age 18: 20.2 percent
• Ages 18 to 49: 51.2 percent
• Age 50 and above: 28.6 percent

Ethnic Distribution

• African American: 39 percent
• American Indian: 0.6 percent
• Asian: 1.1 percent
• Caucasian: 56 percent
• Hispanic: 1.8 percent
• Other: 1.5 percent

Other Information

• Passed FDA audit with zero deficiencies for a four-year clinical trial with a large subject population
• Computerized patient-tracking system
• Fluent with remote data entry (RDE)
• Fully compliant with Health Insurance Portability and Accountability Act of 1996
• Site not under jurisdiction of the local IRB and is able to utilize central IRB services
• IATA trained for the shipment of hazardous materials
• Comprehensive SOPs
• CLIA-waived, certified laboratory
• Certificate for certified provider-performed microscopy procedures
• Federalwide Assurance Number (FWA)