East Bay Clinical Trial Center recruits, manages and executes clinical research protocols for the pharmaceutical and biotechnological industry focusing on Phase II, III and IV trials. We have provided quality clinical trial services for the following sponsors:

Abbott Laboratories, Alpha, Alteon, Amira, Amylin, AstraZeneca, Bayer Pharmaceuticals and Diagnostics, Boehringer Ingelheim, Bristol Myers Squibb, Ciba-Geigy, Cygnus, Glaxo, Genentech, Genomics, GlaxoSmithKline, Hoechst Marion Roussel, Hoffman La-Roche, Johnson and Johnson, Kos, Lifescan, Eli Lilly Research Laboratories, Magainin, Merck, Novartis, Novo-Nordisk, NPS-Allelix, Parke-Davis, Pharmacia, Pfizer, Pharmaceutical Research Institute, Proctor and Gamble, OrthoBiotech, Inc, Ortho McNeil, Sankyo, Sanofi-Synthelabo, Searle, SmithKline Beecham Pharmaceuticals, Takeda of America, Telios, Viropharm and Wyeth-Ayerst.

We have worked with the following Clinical Research Organizations: Medex, Besselaar, Covance, IBAH, IBRD/Phoenix, ICON, Innovex, Inveresk, Kern McNeill International, Lineberry, Omnicare, Paragon, Paraxel, PCRS/Rapid Trials, Pharmanet, PPD, PRA and Quintiles.

The treatment of diabetes mellitus--its monitoring as well as the treatment and prevention of diabetic complications--has been the major focus of our research. However, with the integration of our program into a 100-provider primary care group and hospitalists we are able to expand into the following therapeutic areas: Anxiety, asthma, atrial fibrillation, congestive heart failure, depression, gastroesophageal reflux, hormone replacement therapy, hyperlipidemia, hypercholesterolemia, hypertension, impotence, irritable bowel syndrome, migraine headaches, obesity, osteoarthritis, osteoporosis, Parkinsons' Disease, sinusitis, smoking cessation and several device studies. In early 2004, we are beginning an inpatient study on hyponatremia.

East Bay Clinical Trial Center has participated in the following clinical trials:

• Diabetes Mellitus- Type 1 or 2
  Oral Agents: Monotherapy
  Combination Oral Agents
  Insulin and Oral Agents
  Insulin Analogues
  Inhaled Insulin
  Nephropathy
  Neuropathy
  Microalbuminura/Hypertension
  Foot Ulcers
  Glucose Monitoring
  Glucose Sensors
• Obesity
  Weight Loss Pharmacotherapy
• Depression
• Gastrointestinal
  Irritable Bowel Syndrome
  Gastroesophageal reflux (GERD)
• Hypertension, Essential
• Hypertension, Isolated Systolic
• Hyperlipidemia
• Hypercholesterolemia
• Osteoporosis
• Osteoarthritis
• Asthma
• Smoking Cessation
• Cold and Influenza
• Adult Growth Hormone Deficiency
• Erectile Dysfunction
• PharmokineticsTesting
• Parkinson's Disease
• Prostate Cancer Prevention
• Urinary Incontinence (Women)
• Medical Device Studies

Roy A. Kaplan, MD, Medical Director

Dr. Kaplan has been involved in clinical trials since 1973 and has acted as principal investigator in more than 150 protocols. He is a Certified Clinical Investigator by the association of Clinical Research Professionals. He is Medical Director of the Center for Diabetes at Mt. Diablo Medical Center, an American Diabetes Association recognized program.

Dr. Kaplan has more than 30 years of extensive experience in endocrinology, metabolism and internal medicine as a private practice physician, as well as his 20+ years of experience as principal investigator in clinical trials.

East Bay Clinical Trial Center currently employs a principal investigator, several sub-investigators and 8 staff members. They also contract with other specialty physicians to serve as principal investigators in clinical trials.

Roy A. Kaplan, MD serves as the Medical Director and also as the Principal Investigator.

Thomas Greely, MD serves as Assistant Medical Director , Principal Investigator on some clinical trials and a Sub-Investigator on other trials.

Jan Griffin, Administrative Director, has 15 years experience in clinical trial administration and over 30 years of experience in the medical field.

Alanna Basile has nine years front office experience in the medical field and two years with research. She is the Regulatory Specialist.

Teri Considine, CMA, CCRC has four years in research and 15 years as a medical assistant. She is also the Recruitment Coordinator.

Julie Fregosi, RN, CRC has 8 years experience as a coordinator in research and 22 years of nursing experience.

Judy Harbison, RN, CCRC has nine years research experience as a nurse coordinator and 14 years of nursing experience.

Carolyn Biondo-Paulson, RN, CDE, CCRC has eleven years of research experiences as a nurse coordinator, 27 years in nursing, and 20 years in clinical diabetes education.

Carol R. Shannon, CMA, CCRC has 13 years of research experience and 15 years of medical assisting experience with Dr. Kaplan.

Sophia Stalters, RN, CDE, CRC has 1.5 years experience in research, 19 years in nursing and 10 years in clinical diabetes education.

Philippa Wright, RN, CRC has three years experience in research and 26 years in nursing.

Shirley Zuorksi, MPH, RD, Registered Dietician, has extensive experience in obese and diabetic patients.

East Bay Clinical Trial Center is located in Concord, California midway between the San Francisco and Sacramento International Airports. Concord is part of Contra Costa County the ninth most populous county in the state. Contra Costa County has approximately 42,000 persons with diabetes mellitus. The Center has access to a demographically diverse patient population of over 1,000,000 residents in the county and also over 120,000 residents of Southern Solano County. Ethnic makeup is Caucasian, African American, Hispanic, Asian and Native American. The site has a database of over 210,000 patients through their association with the John Muir/Mt. Diablo Health Network and an additional database access of 8,000 patients of the Mount Diablo Diabetes Center as well as their own database of over 7,500 patients.

Cardiology/Vascular Diseases
Endocrinology
Gastroenterology
Musculoskeletal
Nephrology/Urology
Neurology
Psychiatry/Psychology