Pharma

Our Experience

Our experience in CKRACentral Kentucky Research Associates, Inc. is a multispecialty clinical research site in Lexington, 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 (Phases 1 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, Central Kentucky Research Associates 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.

CKRA has conducted over 500 Phase I, II, III, and IV clinical trials in the areas of Allergy, Cardiology, Dermatology, Endocrine/Metabolism , Gastroenterology, Infectious Diseases, Musculoskeletal, Neurology, Pain Management, Pediatrics, Respiratory, Urology, and Women’s Health. Patients are recruited through the company’s extensive database and through advertising mediums such as television, radio, and print.

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

  • Completion of over 10 Phase I pre-clinical kinetics trials
  • Computerized study management tracking system
  • Comfortable waiting room with snack bar
  • Remote and Internet data entry experience
  • Monitor area with phone, fax, copier, shredder and dedicated computer lines
  • Locked CRF library
  • Standardized and locked regulatory files
  • On-site overnight facility
  • On-site short-term storage facility
  • Off-site long-term storage facility
  • Initial regulatory packets completed within 48 hours of receipt
  • Contract/Budget negotiations completed within 48 hours of receipt
  • Capability to perform clinical trials using schedule 1 drugs
  • For protocols that involve the use of biologic agents, CKRA utilizes the review services of the Western IRB Institutional Biosafety Committee

Click for more information about our research studies and who we work with.

Patient Recruitment & Demographics

Patient Recruitment & DemographicsIn addition to being able to recruit patients through our Investigators and their extensive private practices, CKRA maintains a research patient database of over 25,000 receptive trial volunteers. This research-only database contains patients who have participated in CKRA trials previously or who have been screened, but did not qualify for participation. Other patients have inquired about trials and have been added to the database. The full-time recruitment staff strives to ensure that prospective patients are thoroughly screened on the phone prior to their office visit to help eliminate screening failures. This staff is also driven to make certain CKRA meets or exceeds contracted enrollment on all trials it conducts.

Advertising, when deemed appropriate, is coordinated through our experienced in-house advertising agency. This relationship allows CKRA to significantly reduce enrollment costs as well as save valuable recruitment time by working directly with media outlets. Advertising campaigns are tailored specifically for each target patient population and include: newspaper, television (local & cable), radio, flyers, health fairs, direct mailings, newsletters, promotional items, posters, and billboards.

Within a day’s drive of 75% of the population of the U.S., Lexington is strategically located at the intersection of Interstates 64 and 75. Located in the heart of Central Kentucky, Lexington and the surrounding area’s population consist of 70% of people who range in age from 18 to 65. This age group is the primary target for the majority of clinical research trials. Specialized demographics include:

Central Kentucky Population

  • Lexington: population 250,000 – Surrounding area: population 450,000
  • 18 Colleges, Universities and Technical schools: population: 50,000

Ethnic Diversity

  • Caucasian 83.9% – African American 13.8% – Other 2.3%

Gender Distribution

  • Female 52% – Male 48%

Programs & Certifications

  • 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

Specialized Experience

  • Studies conducted in adolescents, pediatrics, adult and special populations
  • PBMC Collection (local processing)
  • Challenge studies
  • IBC
  • Biosafety Level 1, 2 universal precautions
  • Special handling procedures
  • Safety immunogenicity and field efficacy trials (non endemic and endemic areas)
  • NIH work on recombinant or synthetic nucleic acids
  • Bio-equivalency/Bio-similar and bio-identical
  • Ability to rapidly enroll large numbers of patients
  • FWA #:  00011640
  • GDUFA #:  3002631466

Diagnostic/Clinic Equipment

Diagnostic/Clinic Equipment