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| CENTER
OVERVIEW |
| Located in Los Angeles, California, the National Research Institute (NRI) is a privately owned clinical research center providing clinical trial services to the pharmaceutical industry. 95% of its research population is Hispanic.
Over the past 28 years, NRI has successfully conducted over 375 national and international Phase II, III, and IV clinical trials in the therapeutic areas of:
- Type II Diabetes
- Hypertension
- Lipid Metabolism
- Obesity
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| NRI
FACTS |
- NRI is housed in a modern 7,000 square foot facility with a certified on-site laboratory
- Maintains high quality assurance standards through weekly staff meetings, regular review of protocol summaries, rapid response to monitoring questions and company queries, and ongoing internal study audits.
- Has passed six consecutive FDA audits with no cited protocol deviations or being issued 483's.
- Has done very well on numerous sponsors QA audits for high enrollment.
- Maintains a computerized patient tracking system.
- Fully HIPAA Compliant.
- Is fluent with RDE (remote data entry)
in many systems.
- All staff members are bilingual in Spanish.
- Patient recruitment is typically achieved by the following means:
| - Extensive in-house patient database |
| (14,000 current research subjects available) | |
- Patient referrals - Advertising: television, newspaper, radio, etc. |
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| MEDICAL
MANAGEMENT |
Andrew Lewin, MD President and Chief Executive Officer
Dr. Lewin serves as Director of NRI, is board certified in Internal Medicine and Nephrology, and has been recognized as a Specialist in Clinical Hypertension by the American Society of Hypertension. He also serves as Associate Professor of Medicine at the UCLA School of Medicine and is an Attending at Cedars-Sinai Medical Center. He has been published extensively in peer-reviewed journals on Hypertension, Diabetes, and Lipid Metabolism. He has been awarded a degree as a Specialist in Clinical Hypertension by the American Society of Hypertension. He has also passed a course in Human Subjects Research Training given by the Society of Principal Investigators and in 2003 was designated a Certified Physician Investigator by the American Academy of Pharmaceutical Physicians.
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STAFF |
- Affiliated Physicians, all board certified in their specialties.
- 13 Clinical Research Coordinators
- Regulatory Department
- Quality Assurance Department
- Only involved in research protocols
- Administrative/Operations Staff devoted solely to research subjects
- Approximately 35 total staff
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| EDUCATIONAL
PROGRAMS/CERTIFICATIONS |
- Comprehensive mentoring and continuing education programs to assist with onsite and offsite clinical research training
- Comprehensive SOP's
- FAA/IATA certified staff for the shipment of hazardous materials
- CPR certified staff
- GCP/ICH trained staff
- HIPAA trained and compliant staff
- Shared care certified (BP)
- Trained in various centralized 12 lead ECG
- Trained in ambulatory cardiovascular monitoring (ABPM + Holter Monitoring)
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| DIAGNOSTIC/CLINIC
EQUIPMENT |
- Large (600sq ft) Drug Storage Room (locked)
- 2 ECG machines (computerized)
- 12 Subject Exam Rooms with Mercury Sphygmomanometers
- 4 Freezers (-20 Celsius)
- Centrifuges
- Tanita Scale (3)
- ABPM + Vascular Compliance Equipment
- Dry Ice Machine with liquid CO2 tanks
- Monitored by closed circuit cameras through-out
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| NRI also has access (one floor away) to : |
- Full X-Ray
- Nuclear MRI
- CT Scanning
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2005 AMR, LLC
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