Clinical Trial Resource Center

Therapeutic Areas

Cardiology/Vascular Diseases
Devices
Endocrinology
Immunology
Nephrology
Neurology
Nutrition and Weight Loss
Psychiatry/Psychology
Vaccines

Center Overview

Metabolic Research Institute, Inc. is a dedicated research site with over 15 years of experience in clinical trials. The site is affiliated with 8 board certified endocrinologists with a patient base of over 16,000 patients. The research site has its own database of additional 8,000 patients. Our PI's, William Kaye, MD and Barry Horowitz, MD have participated in over 200 clinical trials, many as top enrollers.

The site has 4 full time coordinators, with certifications including BA, CCRC, MA and phlebotomy. Our coordinators years of experience range from 9-18 years. Our professional team also consists of a dedicated Regulatory Coordinator, Patient Recruiter, Laboratory Coordinator, Chief Financial Officer, Clinical Operations Supervisor and Business Development Liaison.

Clinical Research Experience

Our site has over 13 years of experience in areas such as diabetes (type I and II), obesity, cardiovascular (HTN, hyperlipidemia, hypercholesterolemia, CV endpoint trials, CHD) neuropathy (diabetic peripheral neuropathy), hypogonadism, erectile dysfunction, thryoid disorders, diabetic nephropathy, rheumatoid arthritis, metabolic syndrome, diabetic retinopathy, osteoporosis, gout, diabetic medical devices (pumps,etc). Other areas of interest are migraines, smoking cessation, flu vaccines, depression, anxiety, and women's health (menopause, hot flashes).

Some of the sponsors we have worked with are the following: Abbott, Amarin, Amylin, Amgen, Astra Zeneca, Boehringer Ingelheim, Bristol Myers Squibb, CPEX pharmaceuticals, Daiichi Sankyo, Eli Lilly, F. Hoffman-LaRoche, Forest Labs, Fujisawa Pharmaceutical, Glaxo, Grunenthal, J&J, Kowa, Lexicon, Mannkind, Medtronics, Merck, Mitsubishi, Myogen, Nabi, Novartis, Novo Nordisk, Pfizer, Phenomix, Quigley, Reata, Sanofi-Aventis, Sanofi-Synthelabo, Solvay, Takeda, Tap, Wyeth, Xoma.

Some of the CRO's we have worked with are the following: ICON, Paragon, MDS Pharma, Covance, Paragon, PPD, INC Research, Constella Group, Clinimetrics, Parexel, Quintiles, Target Research, ISS, Medpace, Kendle, PRA International, Integrium, Duke Clinical Research, Partners, PharmaNet, Covalent Group, Premier Research Group, United BioSource Corporation.

Facility Description

We conduct Phase II-IV trials, age 18 and older as outpatients only. We have dedicated space for CRA's with high speed internet access, wireless internet and phone lines, overlooking the beautiful intercoastal waterway. We are located within walking distance of the Good Samaritan Medical Center emergency department (all physicians are on staff at the hospital). We are within walking distance to the public transportation drop off/pick up site.

Our equipment consists of the following: ECG, emergency equipment, on-site CLIA certified lab, locked drug room dedicated to research drugs and devices only, 2 centrifuges, -20 freezer with temperature control and log, 2 refrigerators with temperature control and log, both on-site and off-site archiving, dry ice delivery available, daily if needed, daily Fed Ex and UPS pickup, 24-hour fax on a dedicated line, individual computers for internet and e-mail access, use of central IRB's and central labs per sponsor/protocol.

Investigator Experience

William Kaye, MD - Co-Director, PI and/or Sub-I, board certified in Endocrinology, Internal Medicine and Nephrology.

Over 15 years research experience:

• Endocrinology
• Cardiovascular
• Diabetic Neuropathy
• Diabetic Nephropathy
• Obesity
• Hypogonadism, erectile dysfunction
• Thyroid Disorders
• Women's Health (menopause, hot flashes)

Barry Horowitz, MD - Co-Director, PI and/or Sub-I, board certified in Endocrinology and Internal Medicine

Over 15 years research experience

• Endocrinology
• Cardiovascular
• Diabetic Neuropathy
• Diabetic Nephropathy
• Obesity
• Hypogonadism, erectile dysfunction
• Thyroid Disorders
• Women's Health (menopause, hot flashes)

Staff Expertise

Andrea Garcia - CCRC - Clinical Operations Supervisor - 9 years
Adriana Donadio - CFO - 23 years
Nelly Delgado - CRC - Study Coordinator - 18 years
Jeanette Mangual-Coughlin - CCRC - Study Coordinator - 10 years
Chantey Roberts - CRC - Study Coordinator 5 years
Lori Davis - CCRC - Study Coordinator 9 years
Rochelle Dobonson - Regulatory Coordinator - 20 years
Kevin Ramdas - Recruitment Coordinator - 1 year
Jenny Wakefield - Recruitment Coordinator - 2 years
Amy L. Clarke - BSN - Business Development Liaison - 5 years

Patient Demographics

We have 2 databases to draw from. Our practice database is over 16,000 patients and our research database is over 8,000 patients. We have males/females ages 18 and over. We have the ability to recruit for certain ethnicities such as Hispanic and African American populations, and age/gender populations such as elderly and/or post-menopausal women. We have a large diabetic population as well as cardiovascular. We use our database and radio/newspapaer advertising/mail drops as our primary recruiting tools.

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.