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| CENTER
OVERVIEW |
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Central Kentucky Research Associates, Inc. is a multi specialty clinical
research site with offices located in Lexington and Mt. Sterling,
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 I 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. CKRA was 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 and 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:
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- Allergy
- Cardiovascular
- Dermatology
- Endocrine/Metabolism
- Gastroenterology
- Infectious Diseases
- Musculoskeletal
- Neurology
- Pain Management
- Pediatrics
- Respiratory
- Urology
- Women's Health
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CKRA FACTS
- 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. 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.
FDA AUDITS
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.
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| MEDICAL
MANAGEMENT |
Deborah L. Dyer, RN, BSN
Founder and Chief Executive Officer
Debbie Dyer owns and operates CKRA, whose reputation is firmly established as one of the nation's most reliable, effective, and accurate research facilities. CKRA has provided a community service as well as a contribution to scientific advancement. Debbie is dedicated to the furtherance of ethical efforts to improve quality of life and at the same time, valuing the safety and comfort of CKRA's patients above all else.
In 1999, CKRA was named a Small Business of the Year Finalist by the Greater Lexington Chamber of Commerce Council of Small Enterprises. 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.
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| PRINCIPAL
INVESTIGATORS |
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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.
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 five years in areas of skin infection, atopic dermatitis, psoriasis, 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 board certified in Gynecology. In 1996, he joined CKRA as a principal investigator and has conducted more than 30 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 eight years, where he has conducted more than 20 pediatric clinical
trials in the areas of allergic rhinitis, GERD, flu, conjunctivitis 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.
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| INSTITUTIONAL
REVIEW BOARDS |
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CKRA is not under the jurisdiction of a local Institutional Review
Board (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.
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| | | PATIENT RECRUITMENT AND DEMOGRAPHICS | |
In addition to being able to recruit patients through our Investigators and their extensive private practices, CKRA maintains a research patient database of over 20,000 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.
Within 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. Lexington is located in the heart of Central Kentucky. 70% of the surrounding area's population range in age between 18 and 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 Business/Technical schools population: 50,000
Ethnic Diversity
- Caucasian 83.9%
- African American 13.8%
- Other 2.3%
Gender Distribution
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| STAFF |
- 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 Endocrinology, Rheumatology and Urology
- 8 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
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| EDUCATIONAL
PROGRAMS/CERTIFICATIONS |
- 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 laboratory - Provider Performed Microscopy Procedures
- Clinical staff certified in smoking cessation counseling
- 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
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| DIAGNOSTIC/CLINIC
EQUIPMENT |
- Freezers (-20ºC)
- Doppler Ultrasound
- Diagnostic Bladder Ultrasound
- Rigiscan
- Transrectal Ultrasound
- Refrigerated Centrifuge
- Fully Stocked Crash Cart
- Dry Ice available daily
- Ambulatory Monitoring
- Stadiometer
- 12 lead EKG
- Drug Storage - limited access, temperature monitored
- Refrigerated Drug Storage
- Narcotics Safe
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- 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
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