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 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 450 Phase I, II, III, and IV clinical trials in the areas of:

• Completion of over 10 Phase I pre-clinical kinetics studies .
  
• Computerized study management tracking system
  
• Comfortable waiting room with snackbar
  
• 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
  
• Off-site overnight facility
  
• On-site short term storage
  
• Off-site long term storage facility
  
• Initial Regulatory Packets completed within 48 hours of receipt
  
• Contact/Budget negotiations completed within 48 hours of receipt

HIPAA

CKRA is fully compliant with the Health Insurance Portability and Accountability Act of 1996 (HIPPA) and the Final Privacy Rule. CKRA's HIPPA Compliance Plan supports a newly-established HIPPA Standard Operating Procedure. Staff has been trained on the importance of patient privacy and protected health information (PHI). CKRA's Notice of Privacy Practices is distributed to each potential research subject, along with a prescreening Consent and Authorization to safeguard their PHI even before it becomes part of a clinical study. As the Security Rule is finalized in the near future, CKRA will establish appropriate processes (consistent with its business model) to be compliant with this aspect of the Act.

FDA AUDIT

On April 15, 1998, Dr. John Pappas was audited by the FDA. It was concluded that Dr. Pappas adhered to all pertinent federal regulations, ICH guidlines and good clinical practices governing his conduct of the clinical investigation under audit. No Form FDA 483 was issued.

ALLIANCE FOR MULTISPECIALTY RESEARCH

CKRA is a member of The Alliance for Multispecialty Research, LLC. Chartered in 1994, AMR is a unique non-SMO network of indepently owned, geographically diverse and highly experienced research practices, each averaging over 15 years in clinical trial participation. Membership, limited by charter to 25 members, is by invitation only and is the culmination of rigorous review and acceptance process. Alliance member capabilities and experience are broadly based across a wide variety of therapeutic areas with stringent membership criteria paralleling infrastructure standards highly valued in the industry.

Located in Nashville, Tennessee, AMR's National Headquaters is financially supported by membership dues rather than from percentage of individual study grants or from additional administrative fees levied to study sponsors. Each central office team member brings over a decade of concentrated industry experience to the organization. This team is dedicated to marketing and promoting site selection, providing centralized support, coordination of expert feasibility assessments and identification of appropriate investigators for sponsors.

In 1999, CKRA was named a Small Business of the Year Finalist by the Greater Lexington Chamber of Commerce Council of Small Enterpises. In addition, Jacquie and Debbie were named finalists for the Working Women Entrepreneurial Excellence Awards in 2000. The United States Small Business Administration named them Kentucky's "Small Business Persons" for the year.

James L. Borders, M.D.                                                                                                                                                             Principal Investigator - Internal Medicine

Board Certified in Internal Medicine, Dr. Borders has served over the past year as an investigator for CKRA. His recent trial experience includes Fibromyalgia and Osteoarthritis.  Dr. Borders has been in private practice since 1982 and currently heads Dr. Borders and 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 and provides CKRA with a diversified pool of patients to recruit from for trial participation. 

Sylvia L. Cerel, M.D.                                                                                                                                                        Principal Investigator - Family Practice

Board Certified in Family Practice, Dr. Cerel has worked with CKRA since 2004 as as investigator.  Dr. Cerel has published extensively on the topics of AIDS, contraception and human sexuality.  She has conducted research at numerous universities over the past 20 years and has also been an instructor of Human Biology at Stanford University.  Her clinical trial experience includes smoking cessation, insomnia, fibromyalgia, pre-menstrual dysphoric disorder, obesity and gout. 

Fernando R. Decastro, M.D.
Principal Investigator - Dermatology

Dr. DeCastro is a board certified dermatologist who has been conducting clinical trials for CKRA for over three years in areas of skin infection, 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. 

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.

Donald E. Edger, M.D.
Principal Investigator - Obstetrics & Gynecology

Dr. Edger is a practicing Ob/Gyn who is board certified in Obstetrics and Gnecology. In 1996, he joined CKRA as a principal investigator and has conducted more than 25 trials in the areas of dysfunctional uterine bleeding, genital herpes, herpes zoster, hormone replacement therapy, sexual dysfunction, oral contraceptives, vaginosis and vulvovaginitis.

Barnett W. Lewis, M.D.
Principal Investigator - Pediatrics

Dr. Lewis has worked with CKRA as principal investigator for over six years, where he has conducted more than 20 pediatric clinical trials in the areas of allergic rhinitis, GERD, flu, conjunctivits 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.

Robertson D. Ward, M.D.
Principal Investigator - Family Practice

Dr.Ward has been conducting research since 2001 in the CKRA Mt. Sterling office. Board Certified in Family Practice, Dr. Ward's group practice has participated in over 15 clinical trials to date.

CKRA is not under the jurisdiction of a local Institutional Review Baord (IRB) and must use a Central IRB. Some Central IRB's utilized areL SAIRB, WIRB, NEIRB, RCRC, Quorum, Essex, Copernicus, Goodwyn, Lee Coast and Chesapeake.

In addition to being able to recruit patients trough our Investigators and their extensive private practices, CKRA maintains a research patient database of over 18,000 receptive trial volunteers. 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 commits to.

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. CKRA has extensive experience in mass mailing, printing, radio and television (network and cable) advertising.

Withing a day's drive of 75% of the population of the US, Lexington is strategically located at the intersection of Interstate 64 and Interstate 75. located in the heart of Central Kentucky, Lexington and the surrounding area's population consists of 70% of people who range in age from 18-65. 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 are: population 450,000
• 18 Colleges, Universities and Business/Technical schools population: 50,000

Ethnic Diversity

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

Gender Distribution

• Female 52%
• Male 48%

• CKRA's bi-monthly newsletter, HealthScope, is sent to current and past participants offering informative medical articles and often featuring local physicians in their area(s) 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 laborator - Provider Performd Microscopy Procedures
• 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

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