Lexington
CENTRAL KENTUCKY
RESEARCH ASSOCIATES

Clinical Trial Services

  • Phase I - IV Outpatient Facility
  • Full-Service Phase I Inpatient Capabilities

Debbie Dyer, R.N., B.S.N.

President/General Manager

In 1991, Debbie Dyer founded Central Kentucky Research Associates (CKRA) in Lexington, KY. CKRA joined AMR in 1997. Debbie received her Bachelor of Science degree in Nursing in 1985 and proceeded to work in nursing and clinical drug research at the Lexington Veterans Administration Medical Center as well as The University of Kentucky Medical Center.  She has been involved in over 700 clinical trials over the past 30 years.   As CEO, Debbie has built a well-respected organization that consistently delivers results by aligning technology, goals, and ongoing improvements to the clinical trial industry.

Central Kentucky Research Associates

CKRA’s headquarters is housed in a 17,000 square-foot facility that contains an outpatient Phase II – IV clinic and an inpatient Phase I unit. CKRA has five full-time clinical research coordinators and six coordinator assistants/recruiters with over 75 years of combined research experience. CKRA has the ability to perform procedurally difficult trials and can successfully recruit special populations. Major indication of specialties include: smoking, vaccines and obesity. CKRA has the ability to perform liposuction, anesthesia, skin biopsies, joint aspiration/injection, ultrasounds, pap smears and endometrial biopsies on site.

I learned alot, I will use the knowledge for the rest of my life.

Study Volunteer

Capabilities List

  • Founded in 1991
  • Located in Lexington, KY
  • Conducted 700+ Phase I –IV trials
  • Patient database of 32,000
  • Inpatient Phase I Unit with 20 beds
  • Outpatient Unit with 8 exam rooms
  • Maintains: FWA, GDUFA,  IBC,  Schedule I License, Schedule II – IV License, CLIA Waiver
  • Ability to process local PBMC samples
  • Ability to perform liposuction, joint aspiration/injection, pap smears, endometrial biopsies, skin biopsies and anesthesia
  • Dedicated double-locked limited-access IP Storage

Equipment List

  • 24/7 Natural Gas
  • Backup Generator
  • CT/PET Scanning
  • ECG/EKG
  • EEG
  • EMG
  • DEXA Scanning
  • Radiology
  • Sonography
  • Spirometry
  • Treadmills
  • Ultrasound
  • X-ray

Phase 1 Unit

Well-Equipped With

  • The Phase I unit is secured with an alarm system that will alert staff to anyone entering or exiting the unit.
  • All subject rooms are equipped a nurse call system
  • -70°C Freezers (2)
  • -20°C Freezers (3)
  • Cold Centrifuge
  • ADRC Extraction Preparation and Injection
  • PBMC Processing
  • Cell Washing
  • Phase 1 Unit
  • Phase II-IV Unit
  • Indoor Dedicated Smoking Rooms
  • Valcom digitized clock system that is a network-timed protocol to keep accurate and consistent timing. This system allows precise timing to the second during PK trials as all clocks are synchronized across the system
  • Contract Turnaround Time: 24-48 Hours
  • Feasibility Turnaround Time: 24-48 Hours
  • Regulatory Turnaround Time: 24-48 Hours
  • Full-Time Compliance Officer
  • Full-Time Retention Specialist (Retention Rate 90%)
  • FWA
  • GDUFA
  • IBC Status
  • Schedule I license and Schedule II-V license for researchers
  • Rapid Enrollment
  • WBENC Certified
  • Backup natural gas generator ensures continued power supply in the event of an electricity outage
  • Ambient and refrigerated centrifuges
  • Microscopes
  • Phlebotomy stations
  • Dedicated processing area
  • Ductless fume hood
  • All laboratory staff maintains current IATA certification.
  • In addition to on-site capabilities, CKRA also has an established relationship with a full-service local lab that can be utilized if needed
  • All staff maintains current GCP certification
  • Clinic staff are certified in CPR
  • CKRA maintains a DEA license for Schedule I-IV drugs
  • There is an on-call registered nurse and physician 24/7 to provide coverage if an emergency arises outside of normal business hours
  • The electronic monitoring system is centralized and alarms are activated if any temperature excursion is noted
  • Safe within the drug room for controlled substance storage
  • On-site short-term and long-term storage facility
  • Initial regulatory packets completed within 48 hours of receipt
  • Contract/Budget negotiations completed within 48 hours of receipt
  • Full-service kitchen

On-Site

  • Doppler Ultrasound
  • Diagnostic Bladder Ultrasound
  • Transvaginal Ultrasound
  • RigiScan
  • Fully Stocked Crash Cart
  • Dry Ice – daily
  • Ambulatory Blood Pressure Monitoring
  • Stadiometer
  • 12 Lead EKG
  • Spirometry
  • Limited-Access Drug Storage
  • Refrigerated Drug Storage
  • Narcotics Safe
  • CO Monitoring
  • -20°C Freezer
  • -70°C Freezer (2)
  • Back-Up Power System

Off-Site

  • Cardiac Stress Test
  • CAT Scan
  • Colonoscopy
  • CT Scan
  • DEXA
  • Endoscopy
  • Exercise Testing
  • Mammography
  • PET Scan
  • Phase I Gamma Scintigraphy Research Unit
  • Radiography
  • Sleep Lab
  • Transcutaneous Oxygen Measurements
  • Ultrafast Nuclear MRI