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Research Center Profile:
Diablo Clinical Research

Center Information

Emily Galdes
Vice President, COO
Diablo Clinical Research
2255 Ygnacio Valley Road, Suite M
Walnut Creek, CA 94598
USA
925-930-7267
925-930-7392 (fax)
egaldes@diabloclinical.com
www.diabloclinical.com
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Therapeutic Areas

Cardiology/Vascular Diseases
Endocrinology
Gastroenterology
Musculoskeletal
Nephrology
Neurology
Nutrition and Weight Loss
Obstetrics/Gynecology (Women’s Health)
Rheumatology
Urology

Center Overview

Diablo Clinical Research is committed to advancing health through medical research and community service.

Our Values:

  • Excellent Patient Care - Diablo Clinical Research provides patients with high quality health care in a comfortable, professional and confidential environment.
  • Valuable Study Data - Diablo Clinical Research presents accurate and timely data to our sponsors
  • Community Health Education - Diablo Clinical Research educates our community and assists pharmaceutical , biotechnology and medical device companies in bringing new and improved therapies and devices to market.

Diablo Clinical Research is an independent research organization located in Walnut Creek, CA. Our late-phase facility focuses on phase II, III, and IV clinical studies. It was established in 1995 and specializes in outpatient studies focusing on treatments for diabetes and its related complications including dyslipidemia, obesity, hypertension, neuropathy and metabolic syndrome as well as osteoporosis, fibromyalgia, arthritis and men’s and women’s health studies.

Our early-phase unit opened in 2004 and is a seven bed, dedicated in-patient unit focusing on phase I and early phase II clinical studies. Many of these studies involve the newest research in diabetes including islet cell regeneration and preservation, nerve regeneration for diabetic neuropathy and continuous glucose monitoring. We have a dedicated on-site staff including two RNs, a senior coordinator, research assistant and administrative support and ten on-call RN’s who are available 24/7 to support the early-phase unit.

We have six clinical investigators to support both our early-phase unit and our late-phase unit, with two clinical investigators on site every weekday and at least one on-call physician available 24/7.

We provide high quality care in a comfortable, professional and confidential environment while presenting accurate and timely data to our sponsors.

Why are we different than other research organizations?

  • We have long-standing relationships with many Central IRBs which allow for quick study starts
  • We are consistently a high enrolling site… enrolling quickly while maintaining high retention rates.
  • We have a dedicated on-site recruiting team, QA/QC team and regulatory team.
  • We pride ourselves on maintaining an organized, welcoming and caring environment for both our study participants as well as our monitors, auditors and visitors
  • We are a centralized clinical trial organization with one contact, simplified, timely contract and budget negotiations
  • Our early-phase unit, supported by our "around-the-clock" nursing staff provides us with the capability to perform PK, frequent blood draws and frequent blood glucose monitoring - all of which are often major components of early phase clinical studies
  • We have a patient database of over 11,000 with the capability to conduct a wide variety of queries based on many different characteristics including disease state, age, gender, and concurrent medications.

Clinical Research Experience

We have conducted approximately 600 clinical studies, both early-phase and late-phase, researching medications and medical devices since 1995 in a variety of therapeutic areas including:

  • Arthritis
  • Cardiovascular Disease
  • Diabetes/Metabolic Syndrome
  • Diabetic Nephropathy
  • Diabetic Neuropathy
  • Dyslipidemia
  • Fibromyalgia
  • Hypertension
  • Irritable Bowel Syndrome
  • Men’s Health-including erectile dysfunction and overactive bladder
  • Migraines/headaches
  • Multiple Sclerosis
  • Obesity
  • Osteoporosis
  • Pain
  • Parkinson’s Disease
  • Renal Insuffiency/Proteinuria
  • Women’s Health-including HRT, hot flushes, over-active bladder, female sexual dysfunction

We have provided quality clinical trail services for the many pharmaceutical, biotechnology and clinical research organizations including:

Abbott, ActivX, Allergan, Amgen, Amylin, AstraZeneca, Bayer, BioSante, Boehringer Ingelheim, Bristo-Myers Squibb, Daiichi Sankyo, Diasome, Elan, Eli Lilly, Essentialis, Forest, Genentech, Generex, GlaxoSmithKline, Hoffman LaRoche, JAZZ, Johnson & Johnson, KineMed, Merck, Metabasis, Novartis, Novo Nordisk, Obecure, Parke-Davis, Pfizer, Pharmacia, Pharmacopeia, Proctor & Gamble, Purdue, Quigley, Radius, Roche, Sangamo, Sanofi-Aventis, Schering- Plough, Schwarz Biosciences, Sciele, Solvay, Takeda, TAP, Teikoku, TolerRx, Transition Therapeutics, Vivus, Wyeth, Constella, ICON Clinical Research, INC Research,Clinimetrics, Ingenix, Integrium, Kendle, MDS Pharma Services, Medpace, Omnicare, Parexel, PharmaNew, Phoenix, PPD, Inc., PRA International, Premier Research, Quintiles, Inc., ReSearch Pharmaceutical Services, Inc., SCIREX, Synergy, Synteract, and TKL Research.

We offer customer- focused, quality-based clinical research support:

  • Experienced research physicians with a combined 70 years (+) of clinical research experience
  • Experienced internal QA/QC monitoring with a combined 15 years monitoring experience
  • Experienced research coordinators with a combined 60__ years clinical research experience
  • Early-phase and late-phase capabilities
  • Secure drug/data storage
  • Each study is conducted in accordance with ICH-GCP and FDA standards
  • High-speed internet access for staff and monitors

In addition to our staff and resources within Diablo Clinical Research, we also have long-standing relationships with and access to mammography, X-ray, MRI and medical laboratories within ½ mile radius of Diablo Clinical Research. We also employ the services of sub-investigators in various specialties including OBGyns, dermatologists, gastroenterologists, rheumatologists, opthamologists, psychiatrists, neurologists and nephrologists.

Potential sponsors of biotechnology, pharmaceutical and medical device companies are invited to visit our website at www.diabloclinical.com or contact us at studies@diabloclinical.com for more information.

Facility Description

Founded in 1995 by Dr. Richard L. Weinstein, Diablo Clinical Research is a state of the art, 16,000 sq. ft. clinical research facility located ½ mile from a regional hospital and 2 miles or less from major transportation lines.

On site, Diablo Clinical Research has:

  • YSI 2300 Glucose/Lactate Analyzer
  • Fully equipped specimen processing lab
  • Refrigerated centrifuge
  • -20°C and -70°C freezers
  • Welch Allyn electrocardiogram machine
  • Hologic Delphi DXA machine
  • Cholestech LDx Lipid analyzer
  • Bayer HgbA1c analyzers
  • Sahara clinical bone sonometer
  • Sensory neuropathy testing equipment with QST technician on staff
  • Crash Cart
  • Back-up Generator
  • Locked and temperature-controlled drug storage (refrigerated and ambient), continuously monitored with daily temperatures logged in addition to min/max for refrigerated and ambient drug storage
  • Secure offsite records storage
  • Designated monitor space with multiple internet access lines
  • Pulmonary Function Testing (PFT) room
  • Dual-energy X-ray Absorptiometry (DXA) room
  • Conference room
  • Separate eating/lounge area for patients

Investigator Experience

Diablo Clinical Research has five clinical investigators:

Richard L. Weinstein, MD
Dr. Richard Weinstein, founder and co-medical director, built the research clinic from his private endocrinology practice of over 30 years.

Dr. Weinstein is board certified in endocrinology and internal medicine and has been involved in clinical research since 1995. He now serves as principal investigator in multiple therapeutic areas for both drug and device studies including type 1 and type 2 diabetes, diabetic neuropathy, dyslipidemia, obesity, metabolic syndrome, osteoporosis, osteoarthritis, fibromyalgia and more.

A leading expert in endocrinology, he has lectured in the areas of diabetes and osteoporosis at local, national and international meetings. Dr. Weinstein also has multiple publications in leading medical journals including Diabetes Care, Clinical Therapeutics, JAMA and the New England Journal of Medicine.

Leonard Chuck, PhD, MD
Dr. Chuck has been with Diablo Clinical Research since 2006 as a sub-investigator and in 2007 he became co-medical director of the facility and principal investigator for a variety of studies.

Prior to joining Diablo Clinical Research, Dr. Chuck was in community practice for twenty years as an internist. Prior to his community work, Dr. Chuck spent ten years as a clinical/laboratory researcher at several major academic institutions including UCLA, Cedars of Lebanon, The Cardiovascular Research Institute at UCSF, The University of Antwerp in Belgium and The University of Calgary.

Mark Christiansen, MD
Dr. Christiansen has been a sub-investigator / principal investigator and early-phase unit medical director with Diablo Clinical Research since 2007. He is an expert and specializes in glucose clamp studies. Dr. Christiansen has prior clinical research experience in over eighty studies including (but not limited to) diabetes type 1 and type 2, neuropathy, dyslipidemia, hypertension, metabolic syndrome, fibromyalgia, osteoporosis, osteoarthritis and obesity.

Dr. Christiansen’s certifications include the National Board of Medical Examiners, the American Board of Internal Medicine, the American Board of Diabetes, Endocrinology and Metabolism and he is a certified clinical densitometrist.

Lambert Chee, MD
Dr. Chee, a sub-investigator and principal investigator, has been with Diablo Clinical Research since 2000. Dr. Chee is also currently the Medical Director at the Cardia Heart Recirculation Center in Walnut Creek, CA.

Dr. Chee’s certifications include the National Board of Medical Examiners, the American Board of Internal Medicine and the Subspecialty Board of Cardiovascular Disease.

Helen Stacey, MD
Dr. Stacey, a sub-investigator with Diablo Clinical Research since 2000, is an internist with a Masters in Public Health. Dr. Stacey has prior clinical research experience conducting studies of potential HIV vaccines at the University of Washington AIDS Vaccine Unit.

Dr. Stacey holds certifications from the National Board of Medical Examiners and the American Board of Internal Medicine.

Michael R. Stein, M.D
Dr. Michael Stein joined Diablo Clinical Research as a principal investigator in 2008. Dr. Stein is an expert and specializes in migraines, Parkinson’s Disease and Multiple Sclerosis studies. Dr. Stein has prior clinical research experience in over fifty studies at the Neurological Research Institute of the East Bay since 2001.

Dr. Stein’s certifications include the American Board of Psychiatry and Neurology and the National Board of Medical Examiners.

Staff Expertise

The staff at Diablo Clinical Research represents our core values which include excellent patient care, valuable study data and community health education.

  • Emily Galdes, VP and COO of Diablo Clinical Research, has over 6 years of clinical trial administration experience.
  • Lori Vitti, Director of Finance & Administration, has over 20 years finance and administration experience.
  • Charlette Vargas, Director of Regulatory Compliance, has over thirteen years of research regulatory experience.
  • Catherine Morimoto, Director of Clinical Operations, has over 6 years of clinical research experience.

Support Staff for both early and late-phase units:

  • Five physicians/clinical investigators
  • One laboratory technician
  • Three in-house regulatory personnel
  • Two in-house QA/QC personnel
  • Five recruitment specialists
  • One registered dietitian
  • Three CDPH-certified DXA technicians
  • Three CDPH-certified PFT technicians

Early Phase Dedicated Staff:

  • One senior coordinator
  • Two research nurses
  • One research associate
  • One administrative assistant
  • Ten RNs on-call 24/7

Patient Demographics

Diablo Clinical Research is located in the San Francisco bay area which is home to over 5.4 million people in a six county recruitment region. The San Francisco population is ethnically diverse with approximately 21% Asians, 20% Hispanics and 8% African-Americans.

Other Information

We have consistently been a top enroller for all of our studies. Specifically, in our early phase studies, we have exceeded goal by 5% and have been awarded all subsequent stages with the sponsoring pharmaceutical company. The average retention rate for all of our studies remains steady at 92%.

We utilize Study Manager clinical trial management software to help track participant and study activities and research compliance.

Contact Center

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the email form below. A representative from the research center will then follow up with you.

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