



 
 |
| |
| |
 |
| CENTER
OVERVIEW |
|
Located within the heartland of the United States, Heartland Research Associates LLC, is an independent, dedicated clinical research site specializing in providing Phase 2 - 4 clinical research services for the pharmaceutical, nutritional, and medical device industries. HRA?s primary site is based in Wichita, Kansas with 3 satellite sites, one located in west Wichita, the second located in Arkansas City, Kansas, and the third in Newton, Kansas. A combined patient database of all four facilities is approximately 85,000 patients and possible research participants.
HRA's mission is to provide quality medical care to their research participants with a commitment to accurate and precise data for their sponsors. The resulting strong relationship with their patients aids in successful recruitment, compliance, and retention.
Originally began as a department of Family Medicine East, HRA's owners developed this highly successful department into its own LLC. HRA has worked with many major pharmaceutical companies in the United States, as well as Europe and Japan. To date, HRA has conducted more than 265 national and multinational clinical trials in the therapeutic areas of:
|
- Dermatology
- Device
- Endocrinology
- Gastroenterology
- Genotyping
- Infectious Disease
- Male Health & Erectile Dysfunction
- Musculoskeletal & Connective Tissue Disorders
- Neurology
- Nutrition
- Ophthalmalogy
- Otolaryngology
- Pain Management
- Pediatrics
- Psychiatry
- Pulmonology/Critical Care
- Respiratory
- Urology/Nephrology
- Vascular/Cardiovascular Disorders
- Weight Loss
- Women's Health
|
|
| HRA
FACTS |
- HRA has been in existence since 1991
- Has a cumulative enrollment success of >114%
- HRA's primary clinical research facility is located within the same facility as Family Medicine East, but is a distinctly separate entity and maintains 3,420 square feet of the 16,580 square foot building with on site laboratory capabilities. The primary site has an additional building next door with 2,912 square feet to provide optimal space for monitor visits and regulatory.
- Maintains a computerized study management tracking system
- Has extensive RDE (remote data entry) experience
- Fully HIPAA Compliant
- Patient recruitment is typically achieved by the following means:
- An internal extensive patient study database - Access to a multitude of affiliated physician patient databases - Patient referrals from community physicians and study participants - Advertising: television, newspaper, radio, etc.
|
| MEDICAL
MANAGEMENT |
Terry L. Poling, MD, DABFP, FAAFP, CCRI
Medical Director
Dr. Terry Poling, MD, DABFP, FAAFP, CCRI, is board-certified in Family Practice and is a co-founder of Heartland Research Associates, LLC. Dr. Poling is an AMA delegate for Kansas, acts as Chairman and Medical Director for the Wichita Preferred Provider Association, and is a Past-President for the Kansas Medical Society. Additionally, Dr. Poling is a Clinical Assistant Professor at the University of Kansas School of Medicine.
Terry D. Klein, MD, DABFP, FAAFP, CCRI
Medical Director
Dr. Terry D. Klein, MD, DABFP, CCRI, is board-certified in Family Practice and is co-founder of Heartland Research Associates, LLC. Dr. Klein is a Clinical Assistant Professor at the University of Kansas School of Medicine. Additionally, Dr. Klein is a President of an IPA, and is a Past President for the Kansas Medical Society and currently holds a board position.
Thomas C. Klein, MD, DABFP, CCRI
Medical Director
Dr. Thomas C. Klein, MD, DABFP, CCRI is board-certified in Family Practice and is a co-founder of Heartland Research Associates, LLC. Dr. Klein is a Clinical Assistant Professor at the University of Kansas School of Medicine. Additionally, Dr. Klein is certified for full privileges in EDG's, fiber optic sigmoidoscopy and colonoscopy.
Scott L. Meyers, MD, DABFP Medical Director
Dr. Scott L. Meyers, MD, DABFP is board-certified in Family Practice. Dr. Meyers has served as a MSSC delegate to the Kansas Medical Society and is currently serving a position on the insurance committee for the County Medical Society. Additionally, Dr. Meyers servers as a Clinical Instructor at the University of Kansas School of Medicine.
Tracy R. Klein, MD, DABFP Medical Director
Dr. Tracy R. Klein, MD, DABFP is board-certified in Family Practice. Dr. Klein is CDE eligible, and is actively involved with an affiliated organization, Heartland Diabetes Associates LLC. |
| AFFILIATIONS |
- Member of the Alliance for Multispecialty Research, LLC (not an SMO)
- Heartland Diabetes Association, LLC aiding the ability of HRA by:
- Providing access to 3,500 active database of diabetic patients - Employing a team of diabetic professionals including a Certified Diabetic Educator |
|
|
- American Diabetes Association certified - Commitment to research |
- HRA's Medical Directors serve as regional and national speakers for pharmaceutical companies. Additionally, they provide lectures on issues concerning physician organizations, demographics, and disease management.
|
| PATIENT
DEMOGRAPHICS |
| HRA maintains an extensive patient database. HRA also receives patient referrals from study participants and community physicians, as well as utilizing various forms of advertisements. HRA's past data reflects an aggregate completion rate of greater that 114% enrollment success. Based within a primary care facility, HRA provides care to a diverse patient population ranging from pediatrics to geriatrics. With an extensive database of greater than 75,000, HRA can work with physicians to identify possible qualified subjects for clinical trials in an expedient manner. The physicians and research staff are committed to patient education involving the clinical trial process. This aids in the ability for HRA to provide a low screen failure rate and a high enrollment rate. |
| STAFF |
- 20 Board Certified Investigators who have a distinct awareness of how to incorporate research into their private practices.
- 6 Certified Trial Investigators
- 1 Research Director
- 3 Site Managers, RN, CCRCs
- 18 Full-time Clinical Research Coordinators
- 6 Patient Referral Specialists
- 1 Quality Assurance CCRC Team Lead
- 2 Quality Assurance Specialists
- 1 Monitor Liaison
- 3 Data Entry Specialists
- 1 Marketing Specialist
- 2 Regulatory Specialists
- Clerical and Clinical Assistants
- 4 Laboratory Specialists
- 50 Full-time Specialists
|
| FACILITY |
MAIN FACILITY
- 6 Dedicated exam rooms
- 3 Monitor rooms with high speed cable internet access
- 2 Drug storage rooms
- 2 Controlled access/locked study drug rooms
- 2 freezers
- 1 Dedicated laboratory and phlebotomy station
- HIPPA compliant facility
- Computerized study tracking software
SATELLITE FACILITIES Each satellite facility maintains:
- 1 CCRC site manager
- Minimum of 1 dedicated exam/tx room
- General storage room
- 1 Controlled access/locked study drug cabinet
- 1 Dedicated monitoring room/station with high speed cable internet connection
- Conference room utilized for site/initiation visits
- Computerized study tracking software
- HIPPA compliant facility
|
| EDUCATIONAL
PROGRAMS/CERTIFICATIONS |
- Comprehensive new-hire training, mentoring, and continuing education programs
- Formal in-house training and financial support for ACRP certification for all coordinating and patient recruitment specialists
- Comprehensive SOPs
- Associated CLIA certified laboratoried/CLIA waiver for HRA
- IATA/FAA certified staff for the shipment of hazardous materials
- CPR certification for all clinical staff
- Diet counseling services
- Shared Care B/P certification
- OSHA compliant
- Bi-monthly newsletter, Vital Health, is sent to current and past research participants offering informative medical articles
- Certified Smoking Cessation Counselors
|
| DIAGNOSTIC/CLINIC
EQUIPMENT/SERVICES AVAILABLE |
- Radiology
- Denisitometry - Hologic Whole Body Scanner - 3 certified physicians
- Uroflow Machine
- Transrectal Ultrasound
- Sahar extremity densitometry
- Refrigerated centrifuge
- EKG Machines
- EGD, sigmoid and colonoscopy services
- Freezers (both -20°C & -70°C)
- Ambulatory Blood Pressure Monitoring - Shared Care CRC's
- Registered Dietician
- CLIA/OSHA Certified Lab & Phlebotomy
- Extremity Densitometry
- Spirometry
- Pollen Counting
- Colposcopy L.E.E.P.
- Pulse Oximetry
|
|
| |
| |
| |
©
2005 AMR, LLC
Powered By LionZone |
|
 |