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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 over 400 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 |
- CRA is housed in a 8,000 square foot modern facility with an on-site laboratory with phlebotomy capabilities
- Maintains a computerized patient tracking system
- Experienced with RDE (remote data entry)
- Utilizes a local IRB which meets monthly
- Can utilize a Central IRB at the Sponsor's request
- Patient recruitment is typically achieved by the following means:
- Large patient database
- Large private practice referral base
- Advertising: newspaper, radio, television, and quarterly newsletters
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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 for the past 12 years.
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 10 years experience conducting clinical trials. |
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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
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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 |
- Drug Storage (locked)
- Freezer (-20° Celsius)
- Refrigerator
- Ultrasound
- Treadmill
- Uroflow Machine
- Dry Ice
- Full Kitchen for Meal Studies
- Radiography
- EKG
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| 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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