Sponsors and CROs are invited to contact our Business Development team.

Because our team of physician Principal Investigators work full-time at the research site, your request will be addressed within one business day. Our full-time regulatory staff specializes in rapid turnaround of documents.

Our site has proudly served thousands of patients since its original founding in 1978. We have completed Phase II-IV clinical trials in therapeutic areas including: cardiology, endocrinology, gastrointestinal, neurology, obstetrics/gynecology, ophthalmology, otolaryngology, pediatrics, pharmacology, psychiatry/psychology, pulmonary, rheumatology, urology, and general health.

Metrics

Looking at all the US sites actively participating in the [Major Depressive Disorder] study, your site is the top #1 performer
— Sr. Patient Recruitment Specialist, Major CRO, October 2014. Estimated study-wide enrollment of 2,300+.

Our multi-specialty clinic has met or exceeded enrollment goals in the majority of studies conducted. Although we are an independent, dedicated research site, the fact that our PIs are full-time, on-site, and dedicated solely to research helps us enroll subjects quickly, ensures quality data for Sponsors, and ensures that patient care is of the highest standard.

To facilitate rapid study startup, we are committed to:

  1. Next day turnaround for regulatory documents, with one point of contact, a regulatory affairs specialist
  2. Next day turnaround for budgets and contracts, with one point of contact, a contracts specialist with signatory authority
  3. Immediate availability to Principal Investigators for CDLs, CRAs, Startup Staff, and other Sponsor/CRO contacts
  4. Using Sponsor's Central IRB, with no need for a local IRB
  5. Clinical Research Coordinators who have already been trained in multiple EDC systems, including eClinicalTrials, InForm, Medidata, Oracle, and TrialLink
Enrollment Metrics from selected ongoing and previous studies
Indication Phase Enrollment
Goal
Total
Enrolled
Enrolled
Per Month
Major Depressive Disorder (ongoing) 3 Competitive 26 2.11
Gout (ongoing) 3 7 40 7.24
Generalized Anxiety Disorder 3 8 19 6.33
Gout 4 11 35 7.5
Hypertension 3 Competitive 19 8.51
Men's Health / Urology / Erectile Dysfunction 2 10 34 11
Women's Health / OB/GYN / Hypoactive Sexual Desire 3 15 30 3

Key Staff

Our three principal investigators are on site full-time, dedicated to clinical research at our research-only private facility.

Elly Lee, MD
Psychiatrist and Medical Director
18 Years of Clinical Research Experience
Investigator Experience on 287 Clinical Research Studies
click here for Dr Elly Lee's CV

Denny Lee, MD
Board-Certified Internist and President
12 Years of Clinical Research Experience
Emeritus Faculty Member, Albert Einstein College of Medicine New York
Fluent in Chinese
Investigator Experience on 130 Clinical Research Studies
click here for Dr. Denny Lee's CV

Dung D. Trinh, MD
Board-Certified Internist and Board-Certified Geriatrician
17 Years of Medical Experience
Clinical Assistant Professor of Medicine, University of California, Irvine
Board Member, Alzheimer's Orange County
United States Marine Corps Veteran
Fluent in Vietnamese
click here for Dr. Trinh's CV

Additional investigators affiliated with our site include:

Christine J. Leehealey, MD
Board-Certified Rheumatologist
11 Years of Medical Experience
Fellow, American College of Rheumatology
Clinical Assistant Professor of Medicine, University of California, Irvine
Staff Rheumatologist, Hoag Hospital and University of California, Irvine Medical Center
Medical Acupuncture for Physicians

Julia Wilson, DNP, RN, FNP-BC
Board-Certified Family Nurse Practitioner
19 Years of Clinical Research Experience
Doctor of Nursing Practice, California State University Consortium at Fullerton
Registered Nurse in the State of California
Former Certified Clinical Research Coordinator, ACRP
Associate Professor, Vanguard University

Hien "Jack" Thanh Tran, MD, PhD
Board-Certified Dermatologist
7 Years of Medical Experience
Attending Staff, Department of Dermatology, University of Southern California
Clinical Assistant Professor of Medicine, University of California, Irvine

David Wei Chia, MD, FACS, MBA
Board-Certified Ophthalmologist
10 Years of Medical Experience
Fellow, American Academy of Ophthalmology
Fellow, American College of Surgeons
Clinical Instructor, University of California, Irvine

Michael Wan, MD, FACOG
Fellow, American Board of Obstetrics & Gynecology

Maya Ziegler, PhD
9 Years of Clinical Research Experience
Psychometric Rater
Licensed Psychologist in the State of California

Our clinical's full-time CRCs, regulatory specialist, and business director are available to meet your clinical and business requests. Staff are trained in GCP, HIPAA, IATA, OSHA, and strictly adhere to clinical practice guidelines.

Nicole Myers, CCRC
Lead Clinical Research Coordinator
10 Years of Clinical Research Experience
22 Years of Health Care Experience
Certified Clinical Research Coordinator, ACRP
Medical Assistant Diploma
IATA and CPR Certified

Tara Parnitvithikul, MA, CRC
Senior Clinical Research Coordinator
6 Years of Research Experience
Certified Rater in Neurological and Psychometric Assessments
PhD student in Psychology, Claremont Graduate University
Master of Arts in Psychology, Pepperdine University
Bachelor of Science in Psychology, University of La Verne

Timothy Shin-Woo Yu, PsyD
Sub-Investigator and Psychometrician
5 Years of Clinical Research Experience
Certified Rater in Neurological and Psychometric Assessments
APA-Accredited Postdoctoral Resident, Kaiser Permanente, Santa Rosa, CA
Doctor of Psychology, Fuller Graduate School of Psychology
Bachelor of Science, UCLA

James Luayon
Senior Clinical Research Coordinator
3 Years of Clinical Research Experience
Certified Rater in Neurological and Psychometric Assessments
Doctor of Medicine, Cebu Doctors' University College of Medicine (Philippines)
Bachelor of Science in Biology, University of Miami

Janet Jimenez, NCPT, CPT-1
Assistant Research Coordinator
1.5 Years of Research Experience
5 Years of Medical Experience
Certified Phlebotomy Technician in the State of California
Medical Assistant Diploma
Fluent in English and Spanish

Sandy Cronce
Regulatory Affairs Administrator
14 Years of Clinical Research Experience
Entrepreneurship coursework, California State University, Fullerton

Ralph Lee, CRCP
Site Director
10 Years of Clinical Research Experience
Bachelors in Operations Research and Management Science, University of California, Berkeley
Management of Engineering and Innovation, UC Berkeley College of Engineering
Certified Clinical Research Contract Professional (CRCP), MAGI
Member, California Society of Certified Public Accountants
Member, Institute of Management Accountants
Consultant, Eli Lilly and Company Medical Research Advisory Board
Consultant, Society for Clinical Research Sites Site Advocacy Group sponsored by INC Research

Keerthi Paliath, BS, MAS, CRC
Certified Psychometric Rater
11 Years of Clinical Research Experience
Master of Advanced Studies in Clinical Research Administration, University of California, San Diego
Bachelor of Science in Psychology, Concentration in Clinical Psychology, University of California, San Diego
Certified Psychometric Rater: HAM-D17, HAM-D24, MADRS, YMRS, CDRS-R, C-SSRS, HAM-A, ADIS-C, PARS
IATA and CPR Certified

Nancy Wassom Bernstein, RN, MS, CCRC
Psychometrician
40 Years of Clinical Experience
21 Years of Clinical Research Experience
Registered Nurse in the State of California
Master of Science in Nursing, University of Colorado, Denver

Patient Demographics

Patients are recruited from database and chart reviews, in concert with marketing that draws from the Greater Los Angeles Area. Because of our high standard of care, we are able to retain more patients. Patients benefit from an ongoing relationship with our physicians, while Sponsors enjoy reduced advertising costs.


While we see patients from the pool of 13 million Los Angeles area residents, our city of Irvine is the leading business city in Orange County, the sixth most populous county in the US, and one of the most diverse. While best known for being the home of Disneyland, we are able to draw upon a diverse patient population that includes Caucasian, Latino, Asian, and African-American participants.

Our Facility

Our new multi-therapeutic site, built in 2016, is an outpatient center located in the Alzheimer's Orange County building, a community organization that reaches 25,000 people a year with educational outreach and support programs.

  • Multiple exam rooms
  • CLIA-Waived Laboratory
  • Certified, experienced phlebotomists
  • -20°, -70° Freezers, as well as refrigerator drug storage
  • Temperature-controlled, double-locked investigational drug storage
  • Temperature alert system monitored 24/7/365 with email/text alerts
  • Backup power generator
  • EKG/ECG - Electrocardiogram
  • Uroflow
  • Bladder Ultrasound
  • 24 hour emergency phone number
  • Dry Ice on site
  • Daily FedEx, UPS, and USPS pickup
  • On-site Records Storage, with long-term off-site records storage
  • Large conference room available for monitors, with a view of the Santa Ana mountains
  • Fax and copy machines available at any time to monitors
  • Free high-speed internet for patients, monitors, and guests - wired or wireless
  • Patient waiting area with HDTV, refreshments, and fresh coffee

We are also able to provide services through our affiliate partners upon request. Examples include but are not limited to: radiology scans (X-Ray, MRI, CT, Tau PET), DEXA, and sperm analysis.

Irvine Clinical Research is 1.5 miles from Orange County/John Wayne Airport (SNA), a convenient airport with direct service to the East Coast. We are adjacent to I-405 (with freeway building signage). Parking is free and plentiful in a private lot. Alternative transportation is available as well.