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.

Experience

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

• Acne
• Allergies & 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 (GERD)
• Gout
• Healthy Volunteers
• Heart Disease
• Hereditary Angioedema (HAE)
• High Blood Pressure (mild, moderate, severe)
• Indigestion/Dyspepsia
• Insomnia
• Irritable Bowel
• Migraines
• Obesity
• Orthopedics
• Osteoporosis
• Pediatrics
• Podiatry
• Post Menopausal Symptoms
• Psoriasis
• Pulmonary Disease
• Renal Transplantation
• Rosacea
• Sexual Dysfunction
• Smoking Alternatives & Devices
• Stress Incontinence
• Tinea Pedis / Athlete’s Foot
• Urinary Tract Infection
• Vaccines
• Women’s Health

Facility

Clinical Research Associates of Tidewater Facts:

• Dedicated outpatient study center in a 4451 square foot clinical facility which includes 4 exam rooms, a large laboratory, a conference room, a dedicated monitoring area, a locked regulatory document room, and locked drug closets
• 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

Diagnostic/Clinic Equipment:

• Belfont Micro Smokerlyzer Breath Carbon Monoxide Monitor
• Refrigerated centrifuge as well as a room temperature centrifuge
• Freezers and refrigerators operate on a backup generator in the event of a power failure
• Norlake Scientific 52 cubic feet 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 (PFT)
• 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
• Hotel arrangements can be made at over 25 locations in the area that are less than 10 miles away from our facility

Investigator

Duane G. Wombolt, MD, FACP, CPI
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 Principal Investigator. He has been conducting various phases of clinical research trials since 1974. He is a lecturer for numerous continuing medical educational 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

Staff:

• Combined clinical research experience of over 73 years
• Extensive network of multi-therapeutic Investigators with practices in:
  • Internal Medicine
  • Nephrology
  • Cardiology
  • Gastroenterology
  • Allergy
  • Immunology
  • Orthopedics
  • Endocrinology
  • Dermatology
  • Gynecology
  • Podiatry
  • Ophthalmology
  • Pediatrics
  • Psychiatry/Psychology
• Certified Principal Investigator (CPI) by the ACRP
• Three certified nurse practitioners
• Certified diabetic educator
• Registered dietician
• Five full time Certified Clinical Research Coordinators
• Cross-trained to handle high volume trials
• Each trial is assigned a primary and secondary Research Coordinator
• Research Coordinators Certifications and Completed Training:
  • Certified Clinical Research Coordinators by the ACRP
  • American Heart Association Certification for Standards and Techniques of Blood Pressure Measurements
  • Smoking prevention and treatment educational training with CME Enterprise
  • 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

Patients

The Hampton Roads/Tidewater area is the 27th largest metropolitan market in the United States. Hampton Roads boast a diverse population of over 1.6 million people. There are six area colleges and universities within minutes from our facility. Norfolk, Virginia 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 over 6500 subjects who have expressed an interest in participating in clinical trials. Retention rates of 95% or greater!

Gender Distribution:

• Males 52%
• Females 48%

Age Distribution:

• Under age 18 20.2%
• Ages 18-49 51.2%
• Ages 50+ 28.6%

Ethnic Distribution:

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

Other

• 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)
• 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
• Certified Principal Investigator (CPI)
• Certified smoke cessation coordinators
• All staff CPR certified
• American Heart Association Certification for Standards and Techniques of Blood Pressure Measurements
• 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)

For additional information, please contact Edie Wombolt - Director of Business Operations ewombolt@crat.org

or

Landon Delone - Marketing Coordinator ldelone@crat.org