Center Overview

Pacific Neuroscience Medical Group is a private clinical research site located in the heart of Ventura County, California. We combine the administrative advantages of private practice with the expertise of true neuroscience specialists.

Our site operates independent of any larger bureaucracy thus eliminating the administrative delays frequently encountered at larger centers. In particular, we are free to use the IRB of the sponsor's choice. We can deliver the fastest turn-around times in the industry, typically one week for IRB review and approval, 48 hours for budget review and approval, and 48 hours for contract review and approval.

Clinical Research Experience

Pacific Neuroscience Medical Group is located in Oxnard, California, an hour north of Los Angeles, easily accessible via route 101 or the Pacific Coast Highway . We offer easy access to major freeways and ample free parking. Our suite, a beautiful new 3,700 square foot custom-designed facility, offers the following amenities for subjects, patients, monitors, and guests:

• Luxurious work environment
  • Large, private office with for monitoring, with:
    • Garden view
    • Private desk
    • Phone
    • Broadband internet access
    • Desktop PC
    • Ready access to high speed facsimile machine on a dedicated line
    • Dedicated personal photocopier
  • Fully equipped conference room
    • 8-foot Mahogany conference table
    • Neuroscience medical library
    • High-lumen multimedia PowerPoint projector system
    • Kitchenette with refrigerator, microwave, and freshly brewed coffee
    • Three coordinator workspaces
• Advanced IT capability with
  • Comprehensive computerized clinical trial data management system (Study Manager),
  • Active clinical research volunteer recruitment database
  • Windows XP LAN
  • Microsoft Office 2003
  • Electronic Data Capture (EDC) capability
• Regulatory compliance guaranteed with
  • State-of-the-art laboratory in office with
    • Locked -20° freezer
    • Locked refrigerator
    • Centrifuge
  • Locked storage for study supplies
  • Temperature-controlled, double locked investigational agent storage
  • Complete standard operating procedures (SOPs) and training program
  • Daily FedEx and Airborne pick-up, daily dry ice drops
• Patient safety and comfort
  • Recruiting and community outreach office
  • Comfortable reception area
  • Patient education area equipped with TV, CD player and VCR
  • Eight (8) fully equipped exam rooms
  • Emergency crash cart kit (Banyan Stat Kit 900)
  • Adjacent to tertiary Regional Medical Center and full emergency services
  • Handicapped accessible

Facility Description

Staff Expertise

Our staff’s individual experience in clinical research ranges from 1 to 18 years. Collectively our investigators and coordinators have over 30 years of clinical research experience. We offer Good Clinical Practice (GCP) and human subjects protection training, education and certification for staff and investigators. We focus on research phases: II through IV.

Therapeutic Areas

Our therapeutic specialties include the following.

• Neurological disorders
  • Alzheimer’s disease
  • Vascular Dementia
  • Parkinson's disease
  • Huntington’s disease
  • Dystonia
  • Tension headache
  • Chronic daily headache
  • Migraine
  • Spasticity
  • Multiple Sclerosis
  • Restless Legs Syndrome
  • Epilepsy
  • Neuropathy
• Disorders that can cause neurological illness
  • Diabetes
  • Hypertension
  • Hyperlipidemia
  • Metabolic syndrome
  • Obesity
• Psychiatric disorders
  • Chronic Pain
  • Depression
  • Anxiety

Partners:

The sponsors we have worked with include:

The CROs with whom we have worked include:

• Advanced Biologics
• Clinimetrics
• Covance
• CroMedica
• ICON
• Symbion
• Kendle
• Medex
• Paragon
• Parexel
• Target
• Parkinson’s Study Group
• Pharmanet
• Pharmaceutical Resources, Inc.
• PRA International
• Quintiles

The Central IRBs with whom we have worked include:

• Chesapeake Research
• Coast IRB
• Copernicus Group
• Essex
• IRB
• New England IRB
• Quorum Review
• Schulman Associates
• St. David’s IRB
• Western IRB

The Central Laboratories with whom we have worked include:

• ACM Medical laboratory
• Bio-Inova
• Covance
• CRL Medinet Global Laboratory
• Quest
• Quintiles

We are fully trained in administration of the following standardized rating scales (partial listing):

Investigator Experience

James P. Sutton, MD: Medical Director/Principal Investigator

Dr. James P. Sutton is a board-certified and fellowship-trained neurologist who specializes in research on Parkinson's disease, Alzheimer's disease and other disorders of the brain. A graduate of the Massachusetts Institute of Technology, he is a scientist as well as a practicing physician. He has over 20 years of experience treating patients with neurological illness. He has conducted over 42 clinical trials in Neurology, and has a wide range of research interests including the study of new drugs for migraine, Parkinson's disease, dystonia, Alzheimer's disease, stroke, neuropathy, and epilepsy. In 1997 Dr. Sutton published a description of an unusual form of familial atypical parkinsonism, leading to the discovery that a known mitochondrial mutation can cause levodopa-responsive parkinsonism. He has published other original research, and most recently authored the chapter on the rare and unusual disorders in Pulst’s textbook "Genetics of Movement Disorders" (Academic Press, New York).

Dr. Sutton has held appointments on the clinical faculty of both USC and UCLA Medical Schools, and has held the title of Medical Director, Movement Disorders at Harbor/UCLA Medical Center, Cedars-Sinai Medical Center, and the California Neuroscience Institute. Dr. Sutton created Pacific Neuroscience Medical Group in 2001, in order to provide state-of-the-art clinical, educational, and research services for patients in Ventura County. He currently serves as its founding Medical Director.

Clinical trial experience

• 42 trials, 12 years

Therapeutic areas of special interest

• Alzheimer's disease
• Parkinson's disease
• Headache
• Chronic Pain

Education and special qualifications

Staff Expertise

R.Jason Fajardo, MS, PA-C: Sub-I / Clinical Research Coordinator

• Clinical trial experience
  • > 80 trials, 9 years
• Therapeutic areas of special interest
  • Neurology
  • Pain management
• Education and special qualifications
  • Certified Physician Assistant /li>
  • Bilingual

Margarita Ramos, CCRC: Certified Clinical Research Coordinator

• Clinical trial experience
  • 80 trials, 10 years
• Therapeutic areas of special interest
  • Neurology
  • Psychiatry
  • Diabetes
  • Obesity
• Education and special qualifications
  • AA
  • CCRC

Patient Demographics

Pacific Neuroscience Medical Group is the only dedicated Neuroscience Clinical Trials Center on the Central California Coast, serving the counties of Ventura, Santa Barbara and San Luis Obispo, as well at the West San Fernando Valley area of Los Angeles. Together, these constitute a demographically diverse region with a population of about 3 million. Ventura County alone, with almost 800,000 residents, is more heavily populated than San Francisco. This population density allows for excellent subject recruitment; at the same time, we are close enough to underserved rural areas that we can offer research opportunities to those unable to travel to Los Angeles. We pride ourselves on our minority outreach efforts, which allow underrepresented populations to participate in the advancement of medical knowledge. In particular, we have an active outreach program for the Latino Community of the Central Coast, utilizing Spanish language print and radio media outlets.

The staff at PNMG have extensive experience with effective patient recruitment / retention strategies. Successful patient recruitment is accomplished via our electronic database, investigator private patients, outside physician referrals, community outreach programs, advocacy groups, and print, radio and television advertising.

Other Information

For further information, and to learn about other actively enrolling clinical trials, please visit our website: www.thisisyourbrain.com.

Contact Information

Jason Fajardo, MS, PA-C or James P. Sutton, MD
Pacific Neuroscience Medical Group, Inc.
1701 Solar Drive, Suite 140
Oxnard, CA 93030
USA
Phone: 805-278-4148 or 877-81-BRAIN
Fax: 805-278-4634
EMail: jason.fajardo@pacificneuroscience.com
Web Site: http://www.thisisyourbrain.com/

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.