Clinical Research Atlanta (Stockbridge)
175 Country Club Drive Building 100
Stockbridge, Georgia 30281
770-507-6867 http://www.clinicalresearchatlanta.com msowell@clinicalresearchatlanta.net

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Site Overview
Clinical Research Atlanta (CRA) is a premier multi-specialty research center located in Atlanta Georgia. Founded in 1992, CRA's team is committed to providing the highest quality Phase I,II, III, IV and OTC clinical research services to the pharmaceutical industry. Quality care, quality research and a professional, friendly staff are our core values.

CRA's keys to success include:

  • Ability to use a central IRB
  • Dedicated regulatory specialist
  • Start up regulatory documents turn-around time 5 days
  • Patient Recruitment Program
  • QA Program
  • Emphasis on investigator and coordinator training
  • Electronic Data Capture (EDC) complete within 24 hours of visit completion

CRA has successfully completed more than 300 Phase I,II, III, IV, and OTC clinical trials. CRA's board certified specialists perform trials in the following therapeutic areas:

Allergy

  • Allergic Rhinitis—Adult & Peds
  • Urticaria

Cardiovascular

  • Hypertension (including ABPM)

Dermatology

  • Atopic Dermatitis
  • Contact Dermatitis
  • Dermatitis
  • Impetigo
  • Psoriasis
  • Rosacea
  • Seborrheic Dermatitis

Endocrine/Metabolism

  • Adult & Pediatric Nutrition
  • Diabetes Mellitus Type 1 and 2
  • Dietary Supplements
  • Dyslipidemia
  • Hypercholesterolemia
  • Obesity 

Gastroenterology

  • Chronic Constipation
  • Diarrhea
  • Dyspepsia
  • Erosive Esophagitis
  • Gastritis
  • GERD
  • Heartburn
  • IBS (Irritable Bowel Syndrome)
  • Nausea
  • Ulcerative Colitis

Infectious Diseases

  • Common Cold
  • Fungal Infections
  • Onychomycosis
  • Respiratory Tract Infections
  • Rhinitis
  • Sinusitis
  • Tinea Pedis (Athlete's Foot)

Musculoskeletal/Rheumatology

  • Ankle Sprain
  • Bursitis
  • Carpal Tunnel Syndrome
  • Fibromyalgia
  • Gout
  • Muscular Pain
  • Osteoarthritis
  • Osteoporosis
  • Rheumatoid Arthritis
  • Tendonitis

Vaccines

  • Avian Flu
  • Hepatitis
  • Influenza
  • Influenza Prevention

Neurological

  • Migraine, Adult & Adolescent
  • Headache
  • Insomnia

Normal Healthy

  • Adult & Pediatrics

OTC Indications

  • Adult & Pediatrics
  • Allergy
  • Asthma
  • Pediatric Growth Trials

Pharmacokinetics

  • Adult & Pediatric

Phase 1 Studies

  • Adult & Pediatric
  • Allergy
  • Hypertension-Osteoarthritis

Respiratory

  • Asthma--Adult & Pediatric
  • Chronic Bronchitis
  • COPD
  • Pneumonia
  • Upper Respiratory Tract Infection

Smoking Cessation

  • Nicotine replacement

Urology/Nephrology

  • BPH (Benign Prostatic Hyperplasia)
  • OAB (Overactive Bladder)
  • Urinary Incontinence
  • Urinary Tract Infections (UTI)

Women's Health Care

  • Contraceptives
  • Hot Flashes
  • Hormone Replacement Therapy (HRT)
  • IBS in Women

CRA has earned the trust of major pharmaceutical organizations, including:

  • 3M Company
  • Abbott Laboratories
  • ADAMS Respiratory
  • Alcon Research
  • Alita Pharmaceuticals
  • Allergy Therapeutics
  • Allied Research, Int.
  • ALTANA, Pharma
  • Alteon
  • Alza Pharmaceuticals
  • Amylin Pharmaceuticals
  • Apotex, Inc.
  • Astellas Pharma
  • AstraZeneca
  • AtheroGenics, Inc.
  • Aventis
  • Baxter Healthcare
  • Biogen
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Byk Gulden
  • Celltech
  • Cerimon Pharmaceuticals
  • Chiltern International
  • Clinsys Clinical Research
  • ClinTrials Research, Inc.
  • Cobâlis
  • Corning Besselaar
  • Covance, Inc.
  • C-TRIALS Pharmaceutical
  • DynPort, LLC
  • Dey Laboratories
  • Dynavax Technologies
  • Endo Pharmaceuticals
  • Endpoint Research
  • Epix Pharmaceuticals
  • Forest Laboratories
  • Genentech
  • GlaxoSmithKline
  • Hoechst Marion Roussel
  • i3 Research
  • ICON Clinical Research
  • INC Research
  • Ingenix
  • Integrated Therapeutics
  • Integrium
  • Johnson & Johnson
  • Kendle International
  • Kern McNeil
  • MARTEK Biosciences
  • MDS Pharma
  • MeDa Pharmaceuticals
  • Medeva
  • Medpace, Inc.
  • MedPointe Pharmaceuticals
  • Med-tap
  • Merck
  • Microbia
  • NicOx
  • Novartis
  • NUTRICIA North America 
  • Nycomed
  • Novum
  • Omnicare
  • Orexigen Therapeutics Inc.
  • Organon USA
  • Paragon
  • Parexel
  • Pfizer Inc.
  • PharmaNet
  • Pharmacopeia, Inc.
  • PPD, Inc.
  • PRA International
  • Quintiles
  • Rhone-Poulenc Rorer
  • RTI Health Solutions
  • Sanofi-Aventis
  • Schering-Plough
  • SCIREX
  • Sepracor
  • SmithKline Beecham
  • Solvay Pharmaceuticals
  • Sucampo
  • SUN Pharmaceuticals
  • Takeda
  • Tanox
  • Tap Pharmaceuticals
  • TEVA Pharmaceuticals, USA
  • TKL Research, Inc.
  • Tioga Pharmaceuticals
  • UCB Inc.
  • Unilever Food & Health 
  • United BioSource Corporation
  • Whitehall-Robins
  • Wyeth
  • Yamanouchi Pharmaceuticals

CRA has established a network of physicians that provide an expanded breadth and depth to its clinical research capacity. Under the direction of Principal Investigator and founder, Nathan Segall, MD,CPI, investigators are selected based on their therapeutic expertise and previous clinical trial experience.

CRA is fully staffed with experienced Certified Clinical Research Coordinators (CCRC) committed to the highest professional standards of data quality, patient care, client service, and medical responsiveness. The coordinators continuously engage in training and familiarize themselves with the latest regulations and techniques.

  • ACRP Certified Clinical Research Coordinators
  • CPR Certification
  • Human Participants Protection Education for Research Teams Certification
  • IATA Certified staff for the shipment of hazardous materials
  • GCP/ICH Guidelines for Informed Consent Process compliance
  • Dietary counseling services
  • Certified Smoking Cessation Counselors
  • Staff certified in LifeShirtâ„¢ Training

CRA enjoys an excellent reputation for consistently meeting or exceeding enrollment goals. By utilizing a variety of recruitment methods, CRA achieves superior patient enrollment and ranks among the top enrolling sites in the nation. CRA‘s staff employs a variety of cost-effective recruitment strategies including:

  • Practice and Research databases that consist of 15,000 patients
  • Physician referrals
  • Print, radio, TV and internet advertising
  • Direct patient mailings
  • Community seminars and lecture
  • Flyer and brochure distribution
  • Newsletters
  • Patient Call Center

Clinical Research Atlanta has:

  • Access to a large metropolitan population exceeding 4 million.
  • Close to 3 major universities (Emory, GA Tech, GA State), and 3 military bases.
  • Both CRA locations utilize Clinical Conductor to manage clinical trial data.

Cardiology/Vascular Diseases
Dermatology/Plastic Surgery
Endocrinology
Gastroenterology
Immunology/Infectious Diseases
Musculoskeletal
Nephrology/Urology
Otolaryngology
Pediatrics/Neonatology
Pulmonary/Respiratory Diseases

CRA has two research locations, the Atlanta (North urban) and Stockbridge ( South suburban). Each location is equipped with the most modern technology available, including:

Diagnostic/Clinic Equipment

  • 6 exam rooms at each facility
  • EKG, Holter Monitoring, LifeShirt ®
  • IV infusion capability
  • Centrifuge
  • Cholestech machines
  • Chest X-ray
  • Stadiometer
  • -20° Centigrade freezer
  • Secure 2°-8° Centigrade refrigerator
  • Certified On-site Diagnostic Laboratory
  • Electronic Data Capture (EDC) complete within 24 hours of visit completion
  • Spirometry, peak flow
  • Access to Uroflow machine
  • Pollen counting
  • Treadmill
  • Access to radiology and ultrasound facilities including Bone Densitometer, Mammography, and MRI
  • Access to Certified Endoscopy unit with 3 suites and recovery room
  • Access to 2 Certified Sleep Labs (4 beds each)
  • PC or laptops for all staff
  • Patient lounge for extended days

Facility

  • Ability to use Central IRB
  • ACRP Certified Clinical Research Coordinators
  • Secured Drug Storage (room temperature & refrigerated)
  • Secured climate-controlled storage for study records
  • Dedicated monitor space with DSL or wireless capabilities, telephone, fax and copier
  • Easy access off major expressway for patients and sponsors
  • Emergency meds, Oxygen, CPR certified staff
  • Back-up Generator
  • Medical Center 2 blocks from site

Phase I/IIa Unit
Early Phase clinical research is conducted at our Stockbridge, Georgia Phase I/IIa unit. The 3,500 square foot, dedicated unit is adjacent to our Stockbridge research site and 2 blocks from the Henry Medical Center.

Facility includes:

  • 20 bed capacity
  • Configurable, separate rooms for male and female subjects.
  • Catered meals prepared to protocol specifications
  • Private lockers
  • Separate restrooms and shower areas
  • Onsite lab for specimen collection, processing, handling and shipping
  • Secure drug storage
  • Procedure room for phlebotomy and IV staging
  • Freezer, centrifuge, crash box, defibrillator, and O2
  • Separate Monitor Area

Amenities

  • Comfortable Subject entertainment area
  • Plasma televisions
  • Movie style seating
  • Ground floor with parking directly outside
  • Wi-Fi internet access
  • Laundry Facilities
  • Covered, outdoor area

Michelle Sowell, CCRC
Clinical Operations Director
Clinical Research Atlanta (Stockbridge)
175 Country Club Drive Building 100, Suite A
Stockbridge, GA 30281
USA
770-507-6867
770-507-1539 (fax)
msowell@clinicalresearchatlanta.net
www.clinicalresearchatlanta.com


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