Center Overview

Central Kentucky Research Associates, Inc. is a multispecialty clinical research site with offices in Lexington, and Mt. Sterling, Kentucky. The ability to recruit evaluable patients rapidly and produce high-quality study results in a timely manner has earned Central Kentucky Research Associates, Inc. (CKRA) a sterling reputation as one of the nation’s leading, independent clinical drug research facilities. This is affirmed by the fact that the company, which ranks in the top 10 percent of the nation’s clinical trial sites in subject evaluability, has conducted trials (Phases1 through IV) for every major drug company in the U.S. and many in Europe and Japan.

Central Kentucky Research Associates (CKRA) makes it possible for people to participate in clinical trials that can change the face of medicine. Founded in 1991 by Deborah Dyer, RN, BSN and the late Jacqueline Smith, RN, BSN, CCRC, CKRA was Kentucky’s first independent clinical drug research facility. CKRA is also one of the few such facilities in the nation that is owned and operated by women who are not physicians.

Clinical Research Experience

Central Kentucky Research Associates has been involved in clinical research for over 18 years. We conduct Phase I, II, III, and IV research. CKRA’s staff is experienced in the following research/therapeutic areas:

• Addiction
• Allergy
• Cardiology / Vascular Diseases
• Dermatology
• Endocrinology
• Gastroenterology
• Immunology / Infectious Disease
• Musculoskeletal
• Pain Management
• Urology
• Gynecology
• Neurology
• Pediatrics
• Pulmonary / Respiratory Diseases
• Rheumatology
• Sleep Disorders
• Vaccines
• Women's Healthcare

Clinical Research Experience

Following is a list of conditions for which Central Kentucky Research Associates has conducted medical research.

Allergies

• Allergic Rhinitis

Cardiovascular

• Essential Hypertension

Dermatology

• Acne
• Atopic Dermatitis
• Genital Herpes
• Herpes Labialis
• Herpes Zoster
• Rosacea
• Skin and Soft Tissue Infections
• Tinea Pedis

Endocrine/Metabolism

• Diabetes Mellitus
• Dyslipidemias
• Dyslipidemias in NIDDM
• Hormone Replacement Therapy
• Obesity
• Obesity in NIDDM

Gastroenterology

• Duodenal Ulcer & Gastric Ulcer
• Gastric Protection (NSAIDS)
• Gastroesophageal Reflux Disease
• Heartburn
• Heartburn-Provocative Meal Studies
• Irritable Bowel Syndrome (IBS)
• Non-Ulcer Dyspepsia

Infectious Diseases

• Acute Bacterial Exacerbation of COPD
• Acute Bronchitis
• Acute Sinusitis
• Community Acquired Pneumonia
• Complicated & Uncomplicated Urinary Tract Infection
• Genital Herpes
• H. Pylori
• Herpes Labialis
• Herpes Zoster
• Influenza
• Skin & Soft Tissue Infections
• Streptococcal Pharyngitis
• Vaginosis
• Vulvovaginal Candidiasis

Musculoskeletal

• Lupus
• Osteoarthritis
• Osteoporosis
• Rheumatoid Arthritis
• Acute Cervical and Lumbar Pain

Neurological

• Acute Back Pain
• Chronic Back Pain
• Chronic Pain Syndromes
• Malignant Pain
• Migraine Headache, Adult and Adolescent
• Post Operative Pain- Bunionectomy Model

Pharmacokinetic Studies

• Inpatient
• Outpatient Pharmacokinetics
• Respiratory
• Acute Bronchitis
• Acute Exacerbation of Chronic Bronchitis
• Bronchial Asthma
• Chronic Bronchitis
• Chronic Obstructive Pulmonary Disease
• Phase 1/Gamma Scintigraphy

Special Formulations

• African American
• Elderly
• Pediatric
• Women’s Health

Urology

• Benign Prostatic Hypertrophy
• Complicated Urinary Tract Infection
• Erectile Dysfunction
• Erectile Dysfunction- NIDDM
• Pyelonephritis
• Rapid Ejaculation
• Uncomplicated Urinary Tract Infection
• Urge Incontinence

Women’s Health Care

• Female Sexual Dysfunction
• Genital Herpes
• Hormone Replacement Therapy
• IBS- Female Specific
• Lack of Sexual Energy
• Oral Contraceptives
• Vaginosis
• Vulvovaginal Candidiasis

CKRA has conducted clinical trials for every major drug company in the U.S. and several in Europe and Japan. We have worked with numerous pharmaceutical companies and CRO’s that include:

Industry CRO's

Facility Description

Central Kentucky Research Associates’ main facility is located in Lexington, KY with the additional capabilities of a satellite office in Mt. Sterling, KY. Due to rapid growth in 2000, CKRA moved into a new 9600 square foot state-of-the-art facility that is conveniently accessible to hospitals, a regional airport, I-75, I-64, and lodging accommodations.

CKRA operates as an outpatient facility with access to inpatient care. Our facility offers the following amenities:

• Reception Area
• Large Examination Rooms
• Individual Monitor Areas
• Conference Room
• Administrative Offices
• Physician Offices
• Computerized Patient Database
• Access to Advertising Company specializing in Patient Recruitment
• Access to Onsite X-rays and DEXA Scans
• Capability to perform clinical trials using scheduled I drugs

Diagnostic/Clinic Equipment (CLIA Certified Laboratory):

• Freezer (-20° Fahrenheit)
• Freezer (-70° Fahrenheit)
• Doppler Ultrasound
• Diagnostic Bladder Ultrasound
• RigiScan
• Transrectal Ultrasound
• Refrigerated Centrifuge
• Fully Stocked Crash Cart
• Dry Ice available daily
• Ambulatory Monitoring
• CO Monitoring
• Stadiometer
• 12 lead EKG
• Spirometry
• Drug Storage - limited access, temperature monitored
• Refrigerated Drug Storage
• Back-Up Power System
• Narcotics Safe

CKRA also has access to the following equipment:

• Endoscopy
• Colonoscopy
• Exercise Testing
• CAT Scanner
• CT Scanning
• PET Scan
• Sleep Lab
• Phase I Research Unit
• Ultrafast Nuclear MRI
• Cardiac Stress Test
• Cystometry
• Radiography
• Transcutaneous Oxygen Measurements
• Mammography
• Diagnostic X-Ray
• DEXA

Investigator Experience

CKRA is affiliated with board-certified physician investigators who conduct its clinical studies.

PRINCIPAL INVESTIGATORS

James L. Borders, M.D.
Principal Investigator- Internal Medicine
Board certified in Internal Medicine, Dr. Borders has served over the past 4 years as an investigator for CKRA. His extensive trial experience includes Fibromyalgia, Smoking Cessation, Insomnia, Vaccines, Osteoarthritis, Obesity, Gout, Migraines and RLS, as well as numerous other indications. Dr. Borders has been in private practice since 1982 and currently heads Drs. Borders & Associates, PSC, a large group practice of six physicians with board certifications in either Internal Medicine or Endocrinology. The practice sees approximately 125 patients per day, providing CKRA with a diversified pool of patients to recruit from for trial participation..

Fernando R. DeCastro, M.D.
Principal Investigator- Dermatology
Dr. DeCastro is a boardcertified dermatologist who has been conducting clinical trials for CKRA for over sixyears in areas of skin infection, atopic dermatitis, psoriasis, tinea pedis and acne. Dr. DeCastro is a partner in the largest dermatology practice in the Central Kentucky area with 10 board-certified Dermatologists as well as a Pediatric Dermatologist..

Donald E. Edger, M.D.
Principal Investigator- Gynecology
Dr. Edger is board certified in Gynecology. In 1996, he joined CKRA as a principal investigator and has conducted more than 40 trials in the areas of dysfunctional uterine bleeding, genital herpes, herpes zoster, hormone replacement therapy, sexual dysfunction, oral contraceptives, vaginosis and vulvovaginitis.

Terrence Robert Grimm, M.D.
Principal Investigator- Urology
Dr. Grimm is a practicing urologist who is board certified in Urology. He has served as a principal investigator for CKRA since 1995. Dr. Grimm has conducted more than 20 clinical trials in the areas of benign prostate hyperplasia, erectile dysfunction, rapid ejaculation, urinary tract infection and unstable bladder.

Barnett W. Lewis, M.D.
Principal Investigator- Pediatrics
Dr. Lewis has worked with CKRA as principal investigator for over nine years, where he has conducted more than 20 pediatric clinical trials in the areas of allergic rhinitis, GERD, flu, conjunctivitis and otitis. A board certified Pediatrician, he has been with his private practice since 1976, as well as working as an assistant professor at the University of Kentucky Medical School.

Staff Expertise

Staff Summary:

• Over 20 multi-therapeutic Investigators board certified in the areas of: Critical Care Medicine, Dermatology, Family Practice, Gastroenterology, Internal Medicine, Nutrition, Obstetrics & Gynecology, Pediatrics, Podiatry, Psychiatry, Pulmonary Disease, Reproductive Endocrinology, Rheumatology, and Urology
• 8 Research Coordinators
• Laboratory Technician and Phlebotomist
• Full-time Operations, Administrative and Recruitment Staff
• Quality Assurance Manager
• OSHA Coordinator
• Regulatory Administrator
• PRN Registered Dietician and Staff Therapist

Central Kentucky Research Associates staff has over 50 years of research experience.

Administrative Staff

Deborah Dyer, RN, BSN
Founder/Chief Executive Officer

Ginger Arthur
Director of Operations and Finance

Susan Lanthorn
Director of Business Development

Cathy Jett
Patient Retention Specialist

Marie Booker
Front Office Administrator

Jeni Wash
Front Office Administrator

Denisha Henry, CMA
Regulatory Administrator

Kathleen MacDonald
Quality Assurance

Joy Soper, CMA
Data Management

Melissa Rhodes
Data Management

Tracy Hudson
Human Resources

Clinical Staff

Christina Riley, RN
Clinic Manager

Yvonne Taul, RN
Clinical Research Coordinator

Judy Kinley, RN
Clinical Research Coordinator

Crystal Reed, CMA
Clinical Research Coordinator

Millie McGee, CMA
Clinical Research Coordinator

Rebekah Shoopman, MSNC
Clinical Research Coordinator

Courtney Taul, CMA
Coordinator Assistant

Deborah Ann Goad, MA, MS, LMFT
Staff Therapist

Carolyn Hofe, BS, RD
Dietician

Kara Smith
Lab Tech

Crystal Lunsford
Lead Lab Tech

Public Relations/Marketing

Greta BonDurant
Director of Marketing and Patient Recruitment

Patient Demographics

CKRA has access to a large patient population. Lexington and adjacent counties are populated with 455,617 people. Lexington demographics alone consists of: Population: 260,512. Median age: 33.1. Per capita personal income: 22,235. Male population: 48%. Female Population 52%. White 83.5%. African-American 14%. Other 2.5%. From the standpoint of age, 21.2% is 0-17, 13.8% is 18-24, 34.1% is 25-44, 20.5% is 45-64, and 10.4% is 65+. These demographics help to contribute to the success of multispecialty research. In addition, we have enrolled patients from the whole state of Kentucky. We are conveniently located near several major universities and regularly recruit through advertising mediums such as TV, radio, newspaper, and newsletter.

CKRA also has a patient database that consists of over 13,000 patients that continually participate in clinical trials.

Other Information

• Owners Debbie Dyer and the late Jacqueline Smith were named Kentucky Small Business Persons of the Year in 1999 by the United States Small Business Administration.
• Finalist for Working Woman Entrepreneurial Excellence Award 2000
• Finalist for Lexington Chamber of Commerce Small Business of the Year 1999.
• CKRA uses a central IRB for all regulatory approvals.
• CKRA clinical trials meet all applicable FDA guidelines.
• All employees are certified in CPR and Biohazard Training.
• HIPPA Compliant
• OSHA Compliant

Educational Programs/Certifications:

• CKRA’s quarterly newsletter, HealthScope, is sent to current and past participants offering informative medical articles and often featuring local physicians in their area of expertise
• CKRA participates in local area health fairs and educational seminars
• Comprehensive mentoring and continuing education programs to assist with on-site clinical research training
• Comprehensive SOPs
• FAA certified staff for the shipment of hazardous materials
• CLIA certified laboratory - Provider Performed Microscopy Procedures
• Clinic Staff certified in smoking cessation counseling
• CKRA's community involvement includes providing hands-on training to students participating in medical assisting externship programs through local colleges and universities.
• CPR certified staff
• OSHA Compliant
• HIPAA trained staff in research guidelines
• Compliant with all applicable HIPAA mandated requirements

Contact Information

Deborah L. Dyer, RN, BSN-CEO

Susan Lanthorn, Business Development
Central Kentucky Research Associates
3475 Richmond Road, 3^rd Floor
Lexington, KY 40509
USA
Phone: 859-264-8999
Fax: 859-264-8799
EMail: Ddyer@ckrainc.com
Web Site: http://www.ckraresearch.com

Currently Enrolling Trials

• Adolescent Migraine
• Chronic Low Back Pain
• Gout
• Hepatitis C
• IBS with Constipation
• RSV Vaccine
• Smoking Cessation

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the E-mail form below. A representative from the research center will then follow up with you.