Clinical Trial Resource Center

Therapeutic Areas

Cardiology/Vascular Diseases
Endocrinology
Family Medicine
Hepatology (Liver, Pancreatic, Gall Bladder)
Immunology
Infections and Infectious Diseases
Internal Medicine
Nephrology
Neurology
Pediatrics/Neonatology
Pulmonary/Respiratory Diseases
Rheumatology
Urology
Vaccines

Center Overview

The Center for Excellence in Aging and Geriatric Health is dedicated to improving the quality of life for people 60 years of age and older ( www.excellenceinaging.org).

The Center for Excellence in Aging and Geriatric Health operates the only Clinical Research Center in Williamsburg, Virginia; with the primary goal of giving patients on the Peninsula and surrounding areas access to investigational status treatments. It is a dedicated, full-time site with highly qualified, certified, and experienced clinical research staff.

The Clinical Research Center is available to conduct any study in an adult population, but focuses on clinical trials for ambulatory aging and geriatric patients and their associated diseases.

Clinical Research Experience

FUNDED CLINICAL RESEARCH /GRANTS AND CONTRACTS:

• A Randomized, Double-Blind, Placebo-Controlled, Efficacy, Safety, and Tolerability Study of XXXXX in the Treatment of Elderly Subjects with Psychosis and Behavioral Disturbances Associated with Dementia of the Alzheimer's Type
• A Randomized, Double-Blind, Parallel-Group study of cardiovascular safety in osteoarthritis patients with or at risk for cardiovascular disease comparing XXX with XXX and XXX.
• A Double-Blind, Parallel-Group comparison of XXX to XXX in patients with moderate to severe Alzheimer’s Disease.
• Open-label Extension Study of XXX in patients with Moderate to Severe Alzheimer’s Disease.
• A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to evaluate the efficacy and safety of XXX in subjects with Alzheimer’s Disease receiving a stable dose of XXX.
• Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to evaluate the efficacy and safety of XXX as Monotherapy in subjects with Alzheimer’s Disease.
• Multi-Center, Randomized, Parallel, Open-Label Study of XXX with stepwise addition of XXX with one injection of XXX vs. a twice-daily premixed insulin regimen in adult subjects with Type 2 diabetes failing dual or triple therapy with oral agents.
• Prospective, Observer-Blind, Randomized, Controlled, Multicenter Study to evaluate the immunogenicity and safety of XXX compared to XXX when administered to adults aged 65 years or older.
• Multi-Center, Randomized, Double-Blind, Placebo-Controlled study to evaluate the safety and tolerability of XXX for up to 26-weeks in patients with mild to moderate Alzheimer’s Disease.
• A Phase 3, Multi-Center, Randomized, Double-Blind Placebo-Controlled study to evaluate the safety and tolerability of XXX for up to 26-Weeks in patients with mild to moderate Alzheimer’s Disease.
• A 24 Week, Prospective, Randomized, Parallel-Group, Double-Blind, Multi-Center Study Comparing the Effects of XXX vs. XXX on Activities of Daily Living and Cognition in Patients with Severe Dementia of the Alzheimer’s Type.
• Phase IV Multi-Year Efficacy Study of XXX High-Dose Trivalent Vaccine Compared with XXX Vaccine in Adults =65 Years of Age.
• Qualitative Assessment of the Patient and Informant Perspective on Mild Cognitive Impairment and Probable Alzheimer’s Disease.
• A Multi-Center Randomized, Double-Blind, Phase 2 Study to Evaluate the Effect of XXX versus Placebo on Renal Function in Gout Subjects with Hyperuricemia and Moderate to Severe Renal Impairment.
• A 24 Week Open-Label Extension to Study XXX: A 24 Week, Prospective, Randomized, Parallel-Group, Double-Blind, Multi-Center Study Comparing the Effects of XXX vs. XXX on Activities of Daily Living and Cognition in Patients with Severe Dementia of the Alzheimer’s Type (ACTION).

Facility Description

The Clinical Research Center is equipped to handle Phase II-IV trials in an adult population, but focuses on studies for ambulatory aging and geriatric patients and their associated diseases. Since 2006, we have participated in over 15 clinical trials for disorders such as Alzheimer’s disease, osteoarthritis, diabetes, gout, hypertension, lupus, overactive bladder, rheumatoid arthritis and vaccine administration.

Our office is located in Williamsburg, VA which was recently named one of the best places to retire by Money magazine. We occupy 2,300 square feet of medical office space, with ample convenient parking, in an easy-to-find location. The space includes patient care areas, modern patient waiting area, numerous examining rooms and offices, access to LAN server and high-speed internet, dedicated monitoring area, lab for specimen processing, refrigerator for laboratory supplies, -70 and -20 freezers for specimen storage, locked drug room including refrigerated medications, conference room, and on-site record storage.

Investigator Experience

Paul E. Evans III, M.D., Principal Investigator
Medical School: University of Connecticut School of Medicine, Doctor of Medicine
Resident Training: Riverside Family Practice Residency Program

Board Certification:

• Certification in Family Medicine
• American Board of Family Practice
• Certificate of Added Qualification, Geriatrics

Professional Memberships:

• American Academy of Family Physicians
• Virginia Academy of Family Physicians
• Newport News Medical Society

Hoskote Nagraj, MD, Sub-investigator
Medical School: Baroda Medical College, M.S. University
Resident Training: Catholic Medical Center of Brooklyn and Queens
Board Certification:

• Certification in Geriatric Medicine, American Board of Internal Medicine
• Certification in Internal Medicine, American Board of Internal Medicine

James Hess, MD, Sub-investigator
Medical School: Medical College of Virginia
Resident Training: Medical College of Virginia

Clifford Henderson, MD, Sub-investigator
Medical School: Medical College of Virginia
Resident Training: Medical College of Virginia

Staff Expertise

Contact: Gina Kavanaugh, RN, CCRP

Study Conduct:

• Protocol evaluation/ Grant writing and submission;
• Financial/budgetary analysis;
• Site preparation;
• Patient recruitment;
• Screening/scheduling;
• Study performance (including Informed Consent and Adverse Event Collection);
• CRF/source documentation;
• Test article accountability;
• Sponsor Communication;
• Study Closure.

IRB/Regulatory Issues:

• Investigational drug/device process;
• Institutional Review Board submission;
• Responsibilities and obligations (Good Clinical Practices and Good Laboratory Practices).

Laboratory/Clinical Activities:

• Ensure proper collection, processing of specimens;
• Develop Laboratory Standard Operating Procedures and Quality Assurance Program;
• Communication with Laboratory Director/ Principal Investigator regarding data generated (including statistical analysis);
• Maintain OSHA, CLIA and CAP standards;
• Maintain supplies/ inventory;
• Maintain equipment (calibration and preventative maintenance);
• Recognize common laboratory values and alerts;
• Assure current laboratory certification;
• Perform study-related procedures (e.g., phlebotomy, vital signs, ECG)

Patient Demographics

Through our association with Riverside Health System, we have access to over 350 physicians and 500,000 patients (~20% of which are over the age of 65) in the Hampton Roads area. Riverside’s state of the art electronic medical record provides targeted connection to potential research candidates.

Other Information

Our site takes pride in meeting enrollment expectations and high quality CRF completion with limited queries.

Our site can use a central IRB for outpatient studies.

Other Information

Our site takes pride in meeting enrollment expectations and high quality CRF completion with limited queries.

Our site can use a central IRB for outpatient studies.

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.