Overview

AMR Lexington (formerly Central Kentucky Research Associates) is a multispecialty clinical research site in Lexington, Ky. The ability to recruit evaluable patients rapidly and produce high-quality study results in a timely manner has earned AMR Lexington a sterling reputation as one of the nation’s leading 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 to4) for every major drug company in the U.S. and many in Europe and Japan.

In 1994, Central Kentucky Research Associates (CKRA) was asked to join the prestigious Alliance for Multispecialty Research (AMR), an elite network of clinical research sites whose membership is by invitation only and the culmination of a rigorous peer review and acceptance process.  Today, AMR is an industry-leading company comprised of 16 of the most highly experienced clinical research centers in the U.S. and serves as a hub for shared marketing, business development and best practices.

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

Research Experience

AMR Lexington has conducted Phase I-IV clinical research trials for over 25 years. The 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 AMR Lexington 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

AMR Lexington 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 CROs.

CROs include:

Araccel Berger & Boyer BioPharm Bradstreet Clinical Research Associates Clinical Trials Management Services ClinTrials, Inc. Collaborative Clinical Research Concentrics Concepts in Pharmaceutical Research Constella Corning Besselaar, Inc. Covalent Research Alliance, Inc Covance Health Decisions i3 Research IBRD Quintiles, Inc. ICON Innovex, Inc. Integrated Research

Kern McNeill International Kendle International MEDEX MTRA Paragon Biomedical, Inc. Parexel International Corporation Pharmaceutical Research Associates Pharmakenetics, Inc. PharmaNet, Inc. Phoenix International Life Sciences PPD Development PPD Pharmaco Premier Research Worldwide Quintiles/BRI SCIREX Corporation SFBC TAB Consulting, Inc. Worldwide Clinical Trials, Inc.

Industry Sponsors 3M Pharmaceuticals Abbott Laboratories Agouron Pharmaceuticals, Inc. Alcon Laboratories Allergan Almirall Allergenics Alpharma USPDD Inc. Altana Inc. Alza Corporation Amgen, Inc. Amylin Anesta Astra Merck Astra Pharmaceuticals Astra Zeneca Atrix Aventis Barr Laboratories, Inc. Bayer Corporation Berlex Laboratories Biovail Boehringer-Mannheim Boehringer-Ingelheim Bristol-Myers Squibb Cypress Daiichi Pharmaceutical Corporation DuPont Pharmaceuticals Company ECR Pharmaceuticals Eisai Eli Lilly Ferndale Galderma Galen G.D. Searle Pharmaceuticals Genetech, Inc. Genelabs Technologies, Inc. Glaxo-Wellcome Hoechst Marion Roussel Hoffman LaRoche IDEC Pharmaceuticals Indevus Janssen Pharmaceutical, Inc. Johnson & Johnson

Knoll Pharmaceutical Company Lidak Merck Human Health Division Merck Research Laboratories Micrologix Mylan Pharmaceuticals, Inc. Neurocrine Novartis Organon Ortho-McNeil Otsuka America Pharmaceuticals Parke Davis Pharmaceuticals Pfizer, Inc. Pharmacia & Upjohn Pozen, Inc. Praecis Proctor & Gamble Corp. Purdue Pharma R.W. Johnson PRI Recordati S.P.A. Reliant Rhone-Poulenc Rorer Roche Bioscience Roche Diagnostics Roche Laboratories Sandoz Pharmaceuticals Company Sankyo, USA Sanofi-Synthelabo Schering Plough Schwarz Pharma Searle Sepracor Smith Kline Beecham Solvay Pharmaceuticals, Inc. Syntex Laboratories, Inc. Takeda America, Inc. TAP Holdings, Inc. TEVA UCB Pharma Vanguard Medica Ltd. Viropharma Watson Whitehall Robins Wyeth Ayerst Zeneca Pharmaceuticals

Facility Description

AMR Lexington is located in a 17,000 square foot, state-of-the-art facility that is conveniently accessible to hospitals, a regional airport, I-75, I-64 and lodging accommodations.

AMR Lexington operates as an outpatient facility with access to in-patient care. Our facility offers the following amenities:

• Computerized study management tracking system
• Reception Area
• Large Examination Rooms
• Individual Monitor Areas
• Phase I Research Unit
• 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 schedule I drugs.

Additionally, AMR Lexington has a 20-bed phase 1 unit that encompasses 6,000 square feet and is adjacent to the phase 1 to 4 research center. AMR Lexington’s phase 1 unit is dedicated to completing healthy-volunteer and special-population early-phase trials. Each subject room is equipped with a private bath, recliner and flat-screen, cable TV and DVD player. Most subject rooms are handicapped accessible. The unit also includes an entertainment lounge offering cable TV, Wi-Fi, DVD and book libraries, and game tables to ensure the comfort of volunteers. Our research unit is also equipped with dedicated smoking rooms, each with SmokeMaster air filtration systems. These totally self-contained, carbon-filtered air cleaners filter smoke and many other irritants with up to 99.8 percent efficiency. Each smoking room also has an odor-free ozone generator, which will oxidize unwanted odors in the room without the use of chemicals or masking deodorizers. Room doors are sealed and have large windows. The doors have optional curtains for patient observation or privacy.

Diagnostic/Clinic Equipment (CLIA Certified Laboratory):

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

AM Lexington also has access to the following equipment:

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

Investigator Experience

Mark S. Adams, MD
Principal Investigator- Internal Medicine

Dr. Adams is board-certified in internal medicine and has participated in academic and phase 1 to 4 clinical research since 1980. He joined Central Kentucky Research Associates (now AMR Lexington) in July 2015. His clinical trial experience includes research in the areas of cardiology, metabolic disorders, endocrinology, neurology, musculoskeletal, infectious disease, smoking and vaccine trials. He is a graduate of Emory University in Atlanta, Ga., the University of Kentucky and the University of Louisville Medical School. Dr. Adams has worked as a physician for the Lexington Clinic as well as Cumberland Medical Associates in London, Ky., and the Veterans Administration Hospital in Lexington, Ky., and served as medical consultant for the Kentucky National Guard.

AMR Lexington also has affiliations with many other well-qualified, board-certified investigators who are able to oversee a variety of different clinical research studies.

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 Disorders, Endocrinology, Rheumatology, and Urology
• 5 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

AMR Lexington’s staff has more than 50 years of research experience.

Patient Demographics

AMR Lexington is located at the intersection of Interstates 64 and 75 in the heart of Central Kentucky’s Bluegrass Region and has access to a large and diverse patient population. According to the 2018 U.S. Census estimate, the population of Lexington-Fayette County and surrounding counties is 516,697, with 80 percent of the people ranging in age from 18 to 65 — the primary target for the majority of clinical research trials. The site is conveniently located near several major universities and regularly recruits study subjects through advertising media, such as social media and internet advertising and through traditional media, including TV, radio and print.

AMR Lexington also has a patient database that consists of more than 38,000 patients who continually participate in clinical trials.

Other Information

• Founders, 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.
• AMR Lexington uses a central IRB for all regulatory approvals.
• AMR Lexington’s clinical trials meet all applicable FDA guidelines.
• All employees are certified in CPR and biohazard training.
• HIPAA compliant.
• OSHA compliant.

Educational Programs/Certifications:

• AMR Lexington participates in local area health fairs and educational seminars.
• Comprehensive mentoring and continuing education programs to assist with onsite 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.
• AMR Lexington’s community involvement includes providing hands-on training to students participating in medical-assisting externship programs through local colleges and universities.