Phase I - Anaheim Clinical Trials

Phase I
ACT
Anaheim
Clinical Trials
Our Certified Principal Investigator:
Peter J. Winkle, MD
Anaheim
Clinical Trials
Phase I
Anaheim Clinical Trials (ACT) is a research center of excellence for the
administration of Phase I through Phase IV clinical trials.
ACT has successfully completed over 1,000 Clinical Research Trials. As one of the largest
independently owned Research Sites in the United States, ACT is an organization committed
to exceeding the needs and expectations of our clients by providing innovative, professional and
superior quality service with integrity and reliability.
Phase I Clinical Trial Capabilities:
• Bioavailability Studies
• Bioequivalence Studies
• Clinical Equivalence Studies
• Dose-ranging Studies, SAD/MAD
• Drug Interaction Studies
• Ethnicity Effect, Including Japanese
Bridging Studies
• Endocrinology/Metabolics
- Diabetes
- Obesity
• Fibromyalgia
• Genitourinary
• Hepatology
• Hypertension
• First-in-Human
• Hyperlipidemia
• Food-effect Studies
• Immunology/Inflammation
• Hepatic and Renal Impaired Studies
• Insomnia/Sleep Apnea
• Pharmacodynamic Studies
• Men’s & Women’s Health
• Pharmacokinetic Studies
• Migraines
• Pilot Studies
• Osteoporosis
• Safety & Efficacy
• Osteoarthritis
• Vaccines
• Pain – acute, Chronic, or Post-operative
• Respiratory/Pulmonary
• Type II Diabetes
Therapeutic Area Interests:
• All Gastrointestinal therapeutic areas
• Bunion Surgery - Pain
• Thorough QTc trials
• Cardiovascular
• Dermatology
ACT
Anaheim
Clinical Trials
The ACT Advantage
Recruitment
Our Patient Recruitment Database Department consists of 5 dedicated
professionals who focus on maintaining the volunteer database. ACT
routinely generates its own patient recruitment materials including
television, radio, Internet and print. We consistently market to our database
of over 23,000 subjects by distributing our quarterly newsletters, and
emails which highlight enrolling studies and give additional information
about our ongoing clinical research trials.
Our large patient database and geographical location provide easy access
to healthy volunteers and special patient populations. As a result, ACT has
achieved recognition as one of the top enrollers in a majority of studies
conducted.
• University students are enthusiastic participants in clinical trials as
healthy, normal subjects. There are several major universities in and
around Orange County including The University of California, Irvine as
well as California State University, Fullerton.
• Southern California has a large and ethnically diverse subject population.
Local Demographics
County
Population %White %Hispanic %Asian %Black
Orange
3,010,759
Los Angeles 9,862,049
48
30
33
47
16
13
Source U.S. Census Bureau: State and County QuickFactsLast. Revised: Tuesday, 05-May-2009.
2
10
Special Patient Populations
• Healthy volunteers • Postmenopausal
women
• First-In-Man
• Rheumatoid arthritis
• Elderly
• Osteoarthritis
• Diabetic
• Special Ethnic
• Hypercholesterol
populations
• Hypertensive
(Japanese bridging
studies)
• Hepatic impaired
• Renal impaired
• Pediatric and
Adolescent
Inpatient & Outpatient Capabilities
ACT is one of the largest independently owned clinical research facilities in the United States.
• Continuous confinement up to 30 days
• Private patient rooms and ward setting
• State-of-the-art entertainment
• Outdoor enclosed patio
• 24-hour medical coverage, 7 days a week
• Emergency Room and Intensive Care Unit located close by
• Free standing Endoscopy Center performing up to 30 colonoscopies or endoscopies six (6) days a week
Sponsors
ACT has partnered with well over 100 pharmaceutical and biotechnology companies to bring you cutting edge therapy.
Abbott Laboratories
Forest
Paion
Salix
Amgen
Gilead
Pfizer
Sanofi Aventis
Astellas
Ironwood
Pozen
Schering Plough
AstraZeneca
Lexicon
QRX Pharmaceuticals
Synergy
Braintree Labs
Novartis
Roche
Takeda
© Disney
Convenient Location
Some of the benefits of our Anaheim/Orange County, California location include:
• Only 12 miles from John Wayne International Airport (SNA), 22 miles from Long Beach Airport (LGB) and 43 miles
from Los Angeles International Airport (LAX)
• Only a 10 minute drive from most major hotel chains including: Marriott, Doubletree, Hilton, Hyatt Regency,
Embassy Suites and many more
• Many exciting things to do and places to visit in Orange County including: arts and culture, golfing, entertainment
and dining, world-class shopping, beautiful beaches and many theme parks including, Disneyland® Park,
Disney California Adventure™ Park, Knott’s Berry Farm and Knott’s Soak City Water Park
Medical Staff
Our Certified Principal Investigator: Peter J. Winkle, MD, is Board Certified in Internal Medicine and
Gastroenterology with over 10 years of clinical trial experience. Dr. Winkle continues to see patients in his
private practice.
We are staffed with 26 full-time Clinical Research Coordinators, a Quality Assurance Auditor and a Registered
Dietician. Our Standard Operating Procedures (SOPs) are written to ensure regulatory compliance, quality and
safety every step of the way
• Ongoing, documented training and development guarantees that the staffs are qualified to perform
all procedures
• All study protocols are reviewed by the Medical Director, Clinic Director, and the Clinical Research Coordinator
to ensure subject safety and strict adherence to regulatory and ethical standards
• All adverse events are documented and addressed during clinical trials. Post-study requirements include follow
up of adverse events and may include post-study physical examinations and clinical laboratory testing to
ensure subject safety
Our Mission
• Advance science and ensure the protection and safety of all patients who choose to participate in our
clinical trials
• Ensure compliance with the government regulatory requirements
• Recognize the value of our client, subject, and employee partnerships
• Exceed customer expectations through a combination of dedication, hard work and perseverance
without compromise
• Champion solutions through innovative thinking
Contact Us:
Linda Gundaker, MBA, MT (ASCP)*
Patrick McLaughlin
Executive Director of Business Development
Executive Director
Anaheim Clinical Trials
Anaheim Clinical Trials
1085 North Harbor Blvd.
1085 North Harbor Blvd.
Anaheim, CA 92801
Anaheim, CA 92801
Mobile: 610-937-2006
714-778-1301
Email: [email protected]
Mobile: 714-856-1150
*Located in West Chester, PA
Email: [email protected]
AnaheimClinicalTrials.com
© 2007 Anaheim Clinical Trials
REV 0811