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 multitherapeutic research site proficient in phase 2 to 4 clinical trials. We are a dedicated clinical research site that shares common areas with multispecialty physicians. With more than 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.

Research Experience

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

Therapeutic Areas

• Family medicine
• Gastroenterology
• Internal medicine
• Orthopedic
• Women’s health

Successfully Completed Studies

• 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
• Endo Pharmaceuticals
• Ferring Pharmaceuticals
• Forest Pharmaceuticals
• Furiex Pharmaceuticals
• Ironwood Pharmaceuticals
• Menarini
• Merck
• Pfizer
• Purdue Pharma
• Redhill Biopharma
• Roche Laboratories
• Salix Pharmaceuticals
• Samumed
• Seikagaku (SKK)
• Taro Pharmaceuticals
• Vertex Pharmaceuticals

And we have worked with these CROs:

• Covance
• ICON Clinical Research
• Novump
• Parexel International
• PPD Development
• Syneos Heath
• Quintiles (IQVIA)
• United Bio Source

Facility Description

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

Specialized equipment onsite (calibrated annually):

• 24/7 continuous temperature-monitoring devices
• Ambient and refrigerated centrifuge onsite
• Secured drug room
• 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 Experience

Hoang T. Nguyen, MD
Principal Investigator

Dr. Nguyen is board certified in internal and family medicine. Dr. Nguyen has been practicing in Orange County since 1990.

Kelvin Mai, DO
Principal Investigator

Dr. Mai has been practicing internal and family medicine since 2006.

Staff Expertise

Regulatory – The regulatory specialist processes the start-up paperwork in under a week and works diligently to maintain all regulatory documents throughout the study.

Business Development – In a team effort, the 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 Paragon Rx Clinical to frequently exceed enrollment standards set by study sponsors.

Clinical Research Coordinators – Study coordinators 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 and NIH certification and documentation.

Patient Demographics

Through our dedicated patient base, our extensive area network and the strong local population density, PRxC has access to a large and diverse patient population. California State University Fullerton  and University of California Irvine are located here in Orange County and enable enrollment from a younger population; and, at the same time, Orange County 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 Information

Paragon Rx Clinical uses sponsor-preferred central IRBs. The following is a list of IRBs this site has previously used:

• Chesapeake
• Copernicus
• New England
• Quorum
• Schulman Associates
• Sterling

Paragon Rx Clinical also has access to local laboratories if needed, including Consolidated Medical Bio-Analysis.