Full-time Investigators. Great results. Repeat business.

ICCR is a dedicated research facility with on-site full-time principal investigators, full-time CRCs, and regulatory staff whose attention is 100% focused on clinical trials. Sponsors come back with frequent repeat business, pleased with the great results ICCR has delivered.

ICCR is a dedicated private clinical research site that has served thousands of patients since its original founding in 1978. We have completed Phase II, Phase II-B, Phase III, Phase III-B, and Phase IV clinical trials in several therapeutic areas, including:

• Cardiovascular System
  • Claudication
  • Coronary Arterial Disease
  • Hypercholesterolemia
  • Hypertension
• Dermatology
  • Acne
  • Eczema
  • Psoriasis
  • Urticaria
• Endocrinology
  • Diabetes Type I
  • Diabetes Type II
  • Diabetic Neuropathy
  • Thyroid Disorders
• EENT
  • Dry Eye
  • Tinnitus
• Gastrointestinal
  • Constipation
  • Esophagitis
  • GERD
  • Irritable Bowel Disorder
• Hematology
  • Anemia
  • Metabolic
  • Dyslipidemia
  • Gout
  • Obesity
• Infectious Diseases
  • Vaccination
• M/S, Rheumatology
  • Fibromyalgia
  • Osteoporosis
  • Osteoarthritis
  • Rheumatoid Arthritis
• Neurology and Psychiatry
  • Alzheimers / Dementia
  • Anxiety
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Bipolar Disorder
  • Depression
  • Eating Disorder
  • Headaches
  • Insomnia / Sleep Disorders
  • Migraine
  • Panic Disorder
  • Post-Traumatic Stress Disorder (PTSD)
  • Schizophrenia
• Obstetrics/Gynecology (OB-GYN)
  • Contraception
  • Dysmenorrhea
  • Female Sexual Disorder (FSD)
  • Hormone Replacement Therapy
  • Menopausal Disorders
  • Premenstrual Disorders
• Pediatrics
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Depression
  • General Anxiety Disorder
  • Migraine
  • Obsessive-Compulsive Disorder (OCD)
  • Social Phobia
• Pharmacology
  • Pharmacokinetics
  • Pharmogenomics
  • Safety Studies
• Pulmonary
  • Bronchial Asthma
  • Bronchitis
  • COPD
  • Pneumonia
  • Smoking Cessation
• Urology
  • Benign Prostate Hypertrophy
  • Erectile Dysfunction
  • Male Sexual Dysfunction
  • Overactive Bladder
  • Premature Ejaculation
  • Urinary Incontinence
• General Health
  • Nutrition (Healthy Study)

We have worked with leading pharmaceutical companies and CROs, including:

3M Abbott Abgenix Acambis Alcon Allergan Alteon AMBI, Inc. Amgen AR Scientific AstraZeneca Aura Labs Barr Laboratories Bayer Berlex Biogen Boehringer-Ingelheim Bristol-Myers Squibb Calpis Cephalon Constella Covance DOV Pharmaceuticals Duramed Elan Eli Lilly Essential Forest Fujisawa Generex GlaxoSmithKline GTx, Inc. i3Research Icon Ingenix IntraBiotics IOMED Janssen McNeil

Medpace Merck Neurobiological Technology Neurocrine Biosciences NexMed Novartis Novo Nordisk Nutrilite Ono Pharmaceutical Organon Ortho-McNeil Otsuka Pentech Pfizer Pozen PPD Proctor & Gamble Quintiles R.W. Johnson Pharmaceutical Research Institute Regeneron Reliant Pharmaceuticals Roche Sankyo Sanofi-Aventis Schering-Plough Searle Sepracor Shire Solvay Takeda TAP Pharmaceuticals Tioga Transcept (formerly TransOral) UBC UCB Pharma Vivus Watson Whitehall Wyeth-Ayerst

Some studies were completed as a subsidiary of Protocare Trials and Radiant Research (2000-2005).

ICCR is an outpatient center adjacent to two major hospitals and 24-hour emergency room care. On-site amenities include:

• Exam rooms
• CLIA-Waived Laboratory
• Phlebotomy
• EKG - Electrocardiogram
• Uroflow
• Bladder Ultrasound
• 24 hour emergency phone number

• Temperature-controlled, double-locked investigational drug Storage
• -20°, -70° Freezers
• Dry Ice on site

• Daily DHL, FedEx, UPS, and USPS pickup
• On-site Records Storage, with long-term off-site records storage

• Microwave and mini-refrigerator
• Large, private lockable conference room dedicated to monitors with internet access and telephones
• Two fax machines, three copy machines
• High speed internet access: wired or wireless

• Patient waiting area with HDTV and refreshments

Our clinic is 6 miles from Orange County/John Wayne Airport (SNA), a convenient and luxurious airport with nationwide flight service. ICCR is easily accessible via the major I-405 and I-5 freeways, as well as the CA-133 tollway. Public transportation includes a nearby bus stop and rail station with serving the greater Los Angeles/San Diego area. ICCR is within walking distance of Candlewood Suites, less than a mile from Doubletree Hotel, and a few minutes' drive from the Irvine Hyatt Regency, Marriott, Crowne Plaza, Embassy Suites, and Residence Inn. ICCR is also within 30 minutes' driving distance of 5-star St. Regis and Ritz-Carlton hotels.

We have two principal investigators whose work is fully dedicated to clinical research at ICCR.

Elly Lee, MD
Expertise: Neuro-Psychiatry Trials
Medical Director, ICCR

Denny Lee, MD
Expertise: Internal Medicine
Former Instructor of Medicine, Albert Einstein College of Medicine New York

Additional investigators include:

Herbert Lee, MD, MPH
Expertise: Gastroenterology
Clinical Assistant Professor of Medicine, University of Southern California

Jeffrey Podlas, MD, FACOG
Expertise: Obstetrics and Gynecology
Chairman Emeritus, Department of Obstetrics and Gynecology, Hoag Hospital Newport Beach

Julie Wilson, RN, MSN, FNP (Sub-Investigator)
Expertise: Family Nurse Practitioner
Nursing Instructor at Golden West College

Maya Ziegler, PhD (Sub-Investigator)
Expertise: Psychology, Child Psychology
Former Post-Doctoral Fellow, University of California-Los Angeles Department of Pediatric Oncology

Ardalan Babaknia, MD, PhD (Sub-Investigator)
Expertise: Gastroenterology, Internal Medicine
Former Instructor & Researcher, Johns Hopkins University

Additional co-investigators in fields of specialty are available. Fields include:

• Endocrinology
• ENT Specialist
• Gastroenterology
• OBGYN/Women's Health
• Ophthalmology
• Psychology/Psychiatry
• Urology
• Radiology
• Rheumatology

Full CVs are available upon request.

ICCR has full-time CRCs, laboratory staff, and a full-time regulatory specialist. Staff are trained in GCP, HIPAA, IATA, and OSHA and strictly adhere to clinical practice guidelines.

Dorene Doherty, BA,
Director of Clinical Operations, Senior Clinical Research Coordinator, Psychometrician
14 Years of Research Experience. 10 Years of Clinical Research Experience
10 Years of Rating Experience.

Sandy Cronce
Regulatory Affairs Administrator
8 Years of Clinical Research Experience

Keerthi Paliath, BS,
Clinical Research Coordinator 4 Years of Research Experience.
2 Years of Clinical Research Experience (Phase I & Late Phases)
CPR, YMRS, MADRS, and IATA Certified

Nancy Wassom Bernstein, RN, MS, CCRC
Psychometrician
18 Years of Clinical Experience
16 Years of Clinical Research Experience

Patients are recruited from database and chart reviews, in concert with marketing that draws from our region of Orange County, California. Irvine is the largest city in Orange County, the fifth most populous county in the United States, and one of the most diverse.

2005 Census Bureau estimates place the total population of Orange County at approximately 3 million people. The non-Latino white population of Orange County was 48%. The 2005 Latino population of Orange County was 32.5%. The Asian population was 15.9%. African Americans constituted 1.9% of the population.

ICCR is experienced in providing Fast-Track document turnaround services, including regulatory, contracts, and budgets. ICCR staff is readily available to speak to Sponsors. Full-time Coordinators, Principal Investigators, and pertinent staff members are available for initiation, close-out, and monitoring visits, as well as investigator meetings. CRCs are experienced in RDC systems, including eClinicalTrials, InForm, Medidata, Oracle, and TrialLink.

ICCR conducts studies in accordance with a sponsor's central IRB.

CenterWatch is listing the following trials that are actively recruiting patients at this center.

• Depression study for adult men and women with investigational antidepressant medications.
• Teens and Migraines: Is Your Child Suffering?

For more information, please contact:

Elly Lee, MD
Medical Director
Irvine Center for Clinical Research
16263 Laguna Canyon Road, Suite 150
Irvine, CA 92618 USA
Phone: 949-753-1663
Fax: 949-753-4761
E-mail:

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the E-mail form below. A representative from the research center will then follow up with you.

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Last updated on June 20, 2008