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Clinical Research Associates, Inc.
1500 Church Street, Suite 100
Nashville, Tennessee 37203 |
| Phone:
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(615) 329-0197 |
| Fax: |
(615) 320-7883 |
| Contact: |
Linda Moore Schipani, RN, MSN
President and Chief Executive Officer |
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| Email:
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CRALMS@aol.com
CenterWatch Website:
http://www.centerwatch.com/pro1434.html
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| CENTER
OVERVIEW |
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Clinical Research Associates (CRA) is a privately-owned, independent clinical research site specializing in providing clinical research services for the pharmaceutical, nutritional, and medical device industries.
Established in 1990, CRA has conducted nearly 500 Phase II, III, IV, and Rx-to-OTC national and multinational clinical trials in the therapeutic areas of:
- Cardiology/Cardiac
Surgery
- Dermatology
- Endocrinology
- Gastroenterology
- General/Plastic
Surgery
- Infectious Disease
- Musculoskeletal
& Connective Tissue Disorders
- Nutrition
- Ophthalmology
- Otolaryngology
- Pain Management
- Pediatrics
- Psychiatry
- Pulmonary/Critical
Care
- Radiology Urology/Nephrology
Vascular/Cardiovascular
- Women's Health
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| CRA
FACTS |
- 9,380 square foot-facility located near downtown Nashville
- Laboratory with refrigerated and ambient centrifuges, ECG room, -70 and -20
freezers
- Controlled-access drug room with coded electronic entry,
refrigerators and freezers
- Dedicated departments for regulatory, financial,
data/quality assurance, and patient recruitment
- Electronic Clinical Trials
Managements System with patient database of more than 25,000 and specialized
search and tracking tools for recruitment
- Experienced with RDE (Remote Data
Entry)
- Utilizes Central IRB
- Patient recruitment is typically achieved by the following means:
- Large patient database
- Large private practice referral base
- Advertising
in television, newspaper, quarterly newsletters and by email
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| MEDICAL
MANAGEMENT |
Linda Moore Schipani, RN, MSN
President and Chief Operating Officer
After receiving her Masters degree in Family Practice Nursing, Ms. Schipani has gained extensive clinical research trial experience, and has successfully managed CRA
since 1997.
Stephan C. Sharp, MD
Medical Director and Principal Investigator
Dr. Sharp is board certified in Endocrinology and Internal Medicine. He received his medical degree from the University of Tennessee and completed an Endocrine fellowship at Vanderbilt University School of Medicine. Dr. Sharp sits on multiple consulting boards and has
been conducting clinical trials since 1996. |
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| PATIENT
DEMOGRAPHICS |
| Located in Tennessee's capitol city, CRA is conveniently situated in the heart of downtown Nashville and is central to its extensive medical community. CRA provides rapid enrollment and prompt completion of its studies with an average dropout rate of less than 15%. |
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| STAFF |
- 18 Physician Investigators board certified in the areas of: Cardiology, Endocrinology, Family Practice, Gastroenterology, Internal Medicine, Nutrition, Obstetrics/Gynecology, Pain Management, Cardiac Thoracic Surgery, Ophthalmology, Pulmonology, Plastic Surgery, Neurology, and Psychiatry
- 8 Study Coordinators
- Office Manager
- Dieticians
- Operations/Administrative staff
- Regulatory Department
- Recruitment Department
- Quality Assurance and Data Entry Department
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| EDUCATIONAL
PROGRAMS/CERTIFICATIONS |
- Comprehensive mentoring and continuing education programs to assist with on site clinical research training
- Comprehensive SOPs
- CLIA certified laboratory
- FAA certified staff for the shipment of hazardous materials
- Active participation in community outreach programs
- Fully HIPAA Compliant
- Certified in Smoking Cessation Counseling
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| DIAGNOSTIC/CLINIC
EQUIPMENT |
- Secure Drug Storage
- and -70 Freezer (-20° Celsius)
- Refrigerator
- Ultrasound
- Treadmill
- Uroflow Machine
- Dry Ice
- Full Kitchen for Meal Studies
- Radiography
- EKG
| | CRA is also affiliated with a diagnostic center that has capabilities to perform most required research diagnostic services including access to the following diagnostic/clinic equipment: |
- DEXA Scanner
- Endoscopy Suite
- Ultrafast CT
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2005 AMR, LLC
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