Clinical Trial Resource Center

Therapeutic Areas

Cardiology/Vascular Diseases
Endocrinology
Family Medicine
Gastroenterology
Hematology
Hepatology (Liver, Pancreatic, Gall Bladder)
Internal Medicine
Musculoskeletal
Nephrology
Neurology
Nutrition and Weight Loss
Obstetrics/Gynecology (Women’s Health)
Orthopedics/Orthopedic Surgery
Pediatrics/Neonatology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Trauma (Emergency, Injury, Surgery)

Center Overview

UMDNJ Clinical Research Organization:

• The University Clinical Research Organization (CRO) offers a gateway for current and future patients and sponsors into campus-wide clinical trial activities.
• The University CRO works with private sponsors to provide a single University-wide contact.
• The University CRO works with clinical trial units and research offices of each UMDNJ school to efficiently and effectively match trial and sponsor needs with University resources.

The Clinical Research Organization at the University of Medicine and Dentistry of New Jersey (UMDNJ) assembles the expertise, resources, intellect and motivation of faculty and staff across three medical schools and a dental school, six clinical research centers, and the technical and scientific capabilities of a state-wide institution to conduct clinical research in nearly all therapeutic areas. Each school and campus provides their own set of comprehensive research activities and is supported by a core of shared administrative competencies in human subjects protections, financial management, legal management and technology transfer. The CRO provides a portal into the University to select services at specific sites, or concurrent services at multiple sites across the state; it matches internal capabilities with external constituents. A full description of our main biomedical research schools can be found at the following CenterWatch.com links:

• New Jersey Dental School, Newark
• New Jersey Medical School, Newark
• Robert Wood Johnson Medical School, New Brunswick
• Cancer Institute of New Jersey, New Brunswick
• School of Osteopathic Medicine, Stratford

The UMDNJ CRO may be reached by contacting Ms. Debbie McCloskey, RN, BSN at CRO@umdnj.edu

School of Osteopathic Medicine

The School of Osteopathic Medicine (SOM) , one of three medical schools at the University of Medicine and Dentistry of New Jersey (UMDNJ), is located in Stratford, New Jersey. Founded in 1976, the school is dedicated to providing outstanding medical education, research and health care services. The school’s mission and underlying emphasis on primary health care reflects our deep ties to Osteopathic philosophy. We are committed to developing diverse, compassionate physicians dedicated to leadership in clinical and academic fields and their community.

SOM is dedicated to research in social, behavioral, clinical, and basic sciences. SOM continues to successfully attract industry sponsored research, clinical trials and educational grants. In the last ten years SOM has more than doubled its funding from outside sponsors and leads among U.S. osteopathic medical schools for. As faculty of UMDNJ, the nation’s largest independent public health sciences university, our faculty offer the latest advances in medical care.

SOM provide significant expertise in the following major institutes:

• The New Jersey Institute for Successful Aging (NJISA), started in 1989, is a nationally recognized "center of excellence" serving older individuals and their families through a continuum of medical care inside and outside the clinical setting and training the next generation of health professionals in the needs of aging individuals. More than 50 faculty, education, research, administrative and support staff work together to provide the latest in evaluation and treatment of common conditions affecting older adults. Our goal is to maintain health, promote wellness and effectively manage chronic illness or disease through a research, multi-disciplinary approach. Clinical faculty include geriatricians; neurologists; neuropsychologists; geropsychiatrists; nurse practitioners; and social workers.
• The NeuroMusculoskeletal Institute offers a variety of services targeting neuromuscular system injury and illness. At our comprehensive pain center we evaluate and treat both acute and chronic pain. Our doctors have a special interest in low back pain, spinal injuries and neuropathic injuries. We have on-site physical therapy and athletic trainers through the Wellness Center and closely with the Orthopedic and Osteoscience physicians to provide a comprehensive approach to pain management.
• The Child Abuse Research Education and Service (CARES) Institute is a national leader in the development of comprehensive diagnostic and treatment programs to address both the medical and mental health needs of children experiencing abuse. The federal government has recognized the CARES treatment program as a national model for detecting and treating child victims of sexual abuse and their families. For nearly two decades, the CARES Institute has provided help and compassion–and ultimately, hope–for children who have experienced abuse.

Dedicated Centers also include the NeuroMusculoskeletal Institute, University Headache Center and other concentrated areas of medial research and care.

University of Medicine and Dentistry

UMDNJ, founded in 1970, has eight schools located throughout New Jersey. Our main campuses are Newark, Piscataway/New Brunswick, Stratford and Camden. Our campus collectively inhabits 185 acres, 64 buildings and 7.2 million square feet.

Our Schools include:

• New Jersey Medical School
• Robert Wood Johnson Medical School
• School of Osteopathic Medicine
• New Jersey Dental School
• Graduate School of Biomedical Sciences
• School of Health Related Professions
• School of Nursing
• School of Public Health

Our health care system includes:

• 2.3 million patient visits to UMDNJ healthcare facilities and faculty practice offices last year.
• Owns and operates UMDNJ-University Hospital (UH) in Newark with 22,192 admissions.
• 221,371 outpatient visits last year
• Owns and operates University Behavioral HealthCare (UBHC), a state-wide behavioral health care provider.
• 4 Principal Teaching hospitals (affiliated)
• 3 University hospitals (affiliated)
• Affiliations with more than 80 New Jersey hospitals and/or health systems
• More than 15 statewide centers of excellence
• UMDNJ’s clinical practices have off campus offices in 32 New Jersey communities.
• UMDNJ has healthcare affiliates in each of New Jersey’s 21 counties.

Clinical Research Experience

Our physicians have been conducting clinical trials for more than 25 years and have worked with all of the major pharmaceutical companies and CROs. We have experience conducting Phase II - IV trials, registry studies and investigator initiated studies in the following therapeutic areas:

• Alzheimer's Disease
• Cardiovascular Disease
• Acute Coronary Syndrome
• Cardiac Prevention
• Hypercholesterolemia
• Hypertension
• Diabetes mellitus
• Gastroenterology
• Migraines
• Multiple Sclerosis
• Obstetrics and Gynecology
• Osteoporosis
• Otitis Media
• Pain Management
• Fibromyalgia
• General Pain Syndromes
• Low Back Pain
• Osteoarthritis
• Rheumatoid Arthritis
• Parkinson's Disease
• Pediatrics and Adolescent Medicine
• Physical Medicine and Rehabilitation
• Pulmonology
• Asthma
• Pneumonia
• Psychiatry
• Bipolar Disorder
• Border Line Personality Disorder
• Depression
• Major Depressive Disorder
• Schizophrenia
• Renal Failure
• Reproductive studies
• Weight Loss

Facility Description

We are equipped to facilitate inpatient and outpatient studies through our faculty practices and affiliated patient facilities. Over 200 SOM University Doctors serve southern New Jersey at 60 clinical offices in over 100 communities and five counties. This multi-specialty school partners with the Kennedy Health System, including the Kennedy divisions in Stratford, Cherry Hill and Washington Township, and Our Lady of Lourdes Medical Center in Camden.

We provide care for pediatrics to geriatrics, with primary care in the departments of Gerontology, Internal Medicine, Pediatrics, Family Medicine and Obstetrics and Gynecology. We have specialists in Cardiology, Endocrinology, Gastroenterology, Geriatrics, Geriatric Psychiatry, Migraines, Neurology, Orthopedics, Pain Management, Pediatrics, Pulmonology, Psychiatry, Adolescent Psychiatry, Sports Medicine and Surgery.

The SOM campus is just 20 minutes from Philadelphia city center and 25 minutes from the Philadelphia airport. There is easy access to UMDNJ-SOM from I-95, I-295 and the New Jersey Turnpike.

Investigator Experience

The school has significant experience in nearly all levels of clinical research in the full breadth of therapeutic areas. As investigators and scientists, our faculty are internationally known as prominent leaders in their respective fields. As physicians, they are motivated to improve not only the general health status of our state, country and world at large, but are also dedicated to applying the best medical care to each patient. Our investigator’s include the following:

Emergency Medicine

• Francis Levin, DO- Chair

Family Medicine

• Joshua Coren, DO- Chair
• Adarsh Gupta, DO
• Katharine Garnier, MD
• Robert Hudrick, DO

Gastroenterology

• Charles Bongiorno, MD- Chair
• John Chiesa, DO
• Donald McMahon, DO

Internal Medicine

• Timothy Dombrowski, DO - Chair
• Elizabeth Helfer, MD Endocrinology
• Donald Barone, DO - Neurologist - Multiple Sclerosis emphasis
• Albert Tahmoush, MD - Neurologist

New Jersey Institute for Successful Aging

• Anita Chopra, MD - Chair - Geriatrician
• Thomas Cavalieri, DO - Dean - Geriatrician
• Stephen Scheinthal, DO - Geriatric Psychiatrist
• Robert Ruchinskas, PhD - Neuropsychologist
• Martin Forsberg, MD - Geriatric Psychiatrist

The NeuroMusculoskeletal Institute

• Richard Jermyn, DO Chair - Pain Management and Physical and Rehabilitation Medicine
• Loretta Mueller, DO - Headache Specialist
• David Mason, DO - Osteopathic Manipulation Medicine
• Joseph Daniel, DO - Sports Medicine

Obstetrics/Gynecology

• Keith Williams, MD - Chair
• Ronald Ayres, DO
• Anthony Salerno, DO

Pediatrics

• Jacqueline Kaari, DO - Chair

Psychiatry

• John O’Reardon, MD
• Narsimha Pinninti, MD
• David Rissmiller, DO
• Stephen Scheinthal, DO Geriatric

Surgery/Bariatric Surgery

• Adeshola Fakaluj, DO
• Abier Abdelnaby, DO

Staff Expertise

SOM clinical trial management is centralized through the Office of Clinical Trials Management (CTM), initiated in 1999. The CTM office provides the Sponsor/CRO with a single point of contact to streamline the conduct of clinical trials from inception to close-out, including, investigator support for IRB and regulatory compliance, contracts and budgets and coordinator support. All coordinators are certified and have a combined total of over 25 years of experience.

Staff Experience:

Patricia McLaughlin, RN, MSN, AOCN, CCRP
Program Manager, Clinical Trials Management Office
UMDNJ
42 East Laurel Rd.,Stratford,NJ.
Room 3216
856-566-6003, FAX 856-566-2773

Kathy Barone, RN, MSCN
Clinical Research Coordinator
Internal Medicine - Neurology

Patient Demographics

We serve an economically and ethnically diverse patient population from the entire state of New Jersey and parts of Pennsylvania.

Other Information

UMDNJ - SOM utilizes the Western Institutional Review Board, for all industry sponsored clinical trials located at:
3535 Seventh Avenue SW
Olympia, WA 98508-2029
Telephone: (800) 562-4789

For investigator-initiated studies are reviewed by University IRB at:
Office of the Institutional Review Board
40 E. Laurel Road, Suite 2305
Stratford, NJ 08084
Telephone: (856) 566-2712

The Institutional Review Board at UMDNJ-SOM Stratford supports research by offering regulatory and administrative assistance and training to the local investigator community. The IRB is part of a University-wide Human Subjects Protection Program with three campus-based IRB systems, education, and a monitoring component.