Overview

Mission Statement: Paragon Rx Clinical (PRxC) is committed to executing every aspect of our business with integrity, passion and professionalism.

Paragon Rx Clinical is a multi-therapeutic research site proficient in Phase II-IV clinical trials. We are a dedicated clinical research site that shares building common areas with multi-specialty physicians. We are located in the heart of Orange County, California. With over 20 years of combined experience in the industry, our staff has earned an impeccable reputation for delivering the best possible care for our patients and subjects.

We are very selective on the studies that we choose to participate in as we will only accept a study that we are confident we have the patient access and expertise to successfully deliver.

Experience

Our team has over 35 years of combined medical experience and over 20 years of clinical research experience. We are highly trained in compliance with GCP & ICH guidelines.

Therapeudic Areas:

• Family Medicine
• Gastroenterology
• Internal Medicine
• Orthopedic
• Women’s Health

Studies Successfully Completed

• Asthma
• Atopic Dermatitis (Eczema)
• Colorectal Cancer Screening
• Chronic Idiopathic Constipation (CIC)
• Chronic Pain
• Diabetes Mellitus
• Diabetic Neuropathy
• Gastroesophageal reflux disease (GERD)
• Hepatitis B
• Hypercholesterolemia
• Hypertension
• H-Pylori
• Influenza
• IBS with Constipation (IBS-C)
• IBS with Diarrhea (IBS-D)
• Liver Cirrhosis
• Lower Back Pain
• Opioid Induced Constipation
• Osteoarthritis of the Knee
• Peptic Ulcer
• Postherpetic Neuralgia
• Urinary Incontinence
• Vaccine Studies

To Date we have worked with the following Sponsors:

• Abbott Laboratories
• Allergan
• AstraZeneca Pharmaceuticals
• Bayer Healthcare Pharmaceuticals
• Boston Pharmaceuticals
• Daiichi Sankyo Pharma Development
• Eli Lilly and Company
• Endo Pharmaceuticals
• Ferring Pharmaceuticals
• Forest Pharmaceuticals
• Furiex Pharmaceuticals
• Ironwood Pharmaceuticals
• Menarini
• Merck & Co.
• Pfizer
• Purdue Pharma
• Redhill Biopharma
• Roche Laboratories
• Salix Pharmaceuticals, Inc.
• Samumed
• Seikagaku (SKK)
• Taro Pharmaceuticals
• Vertex Pharmaceuticals

And we have worked with these CROs:

• Covance
• ICON Clinical Research
• Novumprs
• Parexel International
• PPD Development
• Syneos Heath
• Quintiles, Inc. (IQIVIA)
• United Bio Source

Facility

Our outpatient facilities are located in the heart of Orange County, California near several major freeways with easy access to public transportation.

Specialized equipment on site (calibrated annually):

• 24/7 Continuous Temperature Monitoring Devices
• Ambient and Refrigerated Centrifuge On Site
• Secured Drug Room
• Crash Cart
• ECG
• First Aid Kit
• Off-Site Secure Record Storage
• Secure Temperature Controlled Drug Storage
• 3-D Ultrasound
• -70° C Freezer with 24 hour monitoring and email alerts
• -20° C Freezer with 24 hour monitoring and email alerts
• Experience with the use of Central laboratories
• Facility for long-term storage of files for completed studies
• Ongoing GCP training
• High Speed Internet
• Study-dedicated fax machine
• Locked/secure IP storage/temp controlled and monitored daily
• Crash cart/emergency resuscitation equipment

  Investigator

  Principal Investigator: Hoang T. Nguyen, MD. He is Board Certified in Internal and Family Medicine. Dr. Nguyen has been practicing in Orange County since 1990.

  Principal Investigator: Kelvin Mai, D.O. has been practicing Internal and Family Medicine since 2006.

  Staff

  Regulatory- the regulatory specialist process the start-up paperwork in under a week and work diligently to maintain all regulatory documents throughout the study.

  Business Development- it is a team effort. Principal Investigator and Study Coordinators are aided in study enrollment and recruitment through the work of the business development staff. Our team members work diligently to pursue all avenues of patient recruitment and help the Paragon Rx Clinical to frequently exceed enrollment standards set by study sponsors.

  Clinical Research Coordinators- study coordinatos work under the direction of the PI in the overall, day-to-day management of clinical trials. All staff members have current GCP training, IATA/DOT, NIH certified and documentation.

  Patients

  Through our dedicated patient base, our extensive area network and the strong local population densitiy Paragon Rx Clinical has access to a large and diverse patient population. The California State University of Fullerton (CSUF) and University State California of Irvine (UCI) are located here in Orange County and enables enrollment from a younger population and at the same time is home to a large number of retirees over the age of 65. Patient enrollment comes from our own patient database, physician referral, advertising (TV, Radio, Print, Internet), direct mail and community relations (health screenings and event promotion).

  Other

  Paragon Rx Clinical uses sponsor preferred central IRB's. The following is a list of IRB's this site has previously used:
  • Chesapeake Institutional Review Board
  • Copernicus Institutional Review Board
  • New England Institutional Review Board
  • Quorum Institutional Review Board
  • Schulman Associates Institutional Review Board
  • Sterling Institutional Review Board
  Paragon Rx Clinical uses sponsor central laboratory, we also have access to local laboratories if needed.
  • Consolidated Medical Bio-Analysis, Inc.