CKRA has conducted over 500 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
  
• Large & comfortable waiting room with snack bar
  
• Extensive remote and internet data entry experience
  
• Monitor area with phone, fax, copier, shredder, and dedicated high-speed computer lines, direct and wireless
  
• Locked CRF and medical records library
  
• Standardized and locked Regulatory files
  
• On-site overnight facility
  
• On-site short term and long-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
• CKRA maintains a Schedule I license and Schedule II-V License for researchers
• Full-service kitchen

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. The staff have 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.

On April 15, 1998, March 13, 2006, July 18, 2006 and June 26, 2008, CKRA was audited by the FDA.  It was concluded that CKRA and its Investigators adhered to all pertinent federal regulations, ICH guidelines and good clinical practices governing the conduct of the clinical investigations under audit.  No Form FDA 483 was issued for any audit conducted at CKRA.  All audits were conducted as the result of high enrollment. 

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 independently 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 Headquarters 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 Enterprises.  Debbie was named a finalists for the Working Women Entrepreneurial Excellence Awards in 2000.

James L. Borders, M.D.

Primary Principal Investigator - Internal Medicine

Board certified in Internal Medicine, Dr. Borders has served over the past years as an investigator for CKRA since 2005.  Dr. Borders has been in private practice since 1982 and is part of a large group practice of six physicians with board certifications in either Internal Medicine or Endocrinology.  The practice provides CKRA with a diversified pool of patients from which to recruit for trial participation.  Dr. Borders has extensive trial experience in smoking cessation, insomnia, vaccines, fibromyalgia, obesity, gout, migraines, and RLS as well as other numerous indications.

Dr. Roberts is board certified in Internal Medicine.  He has conducted trials as a Principal Investigator since 1975 in the U.S. and Central America and has been with CKRA since 2004

Brigitte Danielle King, M.D.

Principal Investigator - Internal Medicine

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

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

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

Dr. Lewis has worked with CKRA for nine years, where he has conducted more than 20 pediatric clinical trials. A board-certified Pediatrician, he has been in a private group practice of 10 board-certified pediatricians since 1976.     

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

In 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.  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.

Central Kentucky Population

• Lexington: population 250,000
• Surrounding area: 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%

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