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Clinical Trials

Expanding options and advancing research

The Clinical Trials Unit of Rochester General Health Systems Endocrine-Diabetes Care and Resource Center is an outpatient facility that since 1988 has conducted clinical research for the pharmaceutical and medical device industries. We strive to advance medical research, to expand medical options, and to bring to our community the safest, most up-to-date medications.

We conduct phase II, III, IIIb and IV research as well as observational studies in diabetes, diabetic retinopathy, diabetic gastroparesis, early renal insufficiency, growth hormone deficiency, hyperlipidemia and hypertension. Our Clinical Trials Unit is equipped with centrifuge, stadiometer, electrocardiograms, dedicated subzero freezer, secure refrigerated drug storage, climate-controlled secure drug storage room and electronic database.

Our physicians – under the direction of Zachary R. Freeman, MD, FACE – are board-certified in internal medicine and endocrinology. We use a local institutional review board (IRB) – RGH’s Clinical Investigation Committee – which meets twice monthly. 

Contact Us

For more information on diabetes clinical trials, contact Amy Winterberger, CCRC, clinical research supervisor, at (585) 922-8434.

Endocrine-Diabetes Care and Resource Center Research
224 Alexander Street, Suite 200
Rochester, New York  14607
Phone: (585) 922-8434
Fax: (585) 922-8060

Areas of Expertise

The unit conducts research in Phases II, III, IIIb and IV, as well as observational studies.  Our therapeutic areas include:

  • Diabetes
  • Diabetic Retinopathy
  • Diabetic Gastroparesis
  • Early Renal Insufficency
  • Growth Hormone Deficiency
  • Hyperlipidemia
  • Hypertension

We have worked with the following Pharmaceutical and Contract Research Organizations:

  • Abbott
  • Amylin Corporation
  • Aventis
  • Bayer Corporation
  • Bristol-Myers Squibb
  • Clinimetrics Research Associates
  • Eli Lilly & Co.
  • Glaxo SmithKline
  • IRBD/Phoenix
  • ICON Clinical Research
  • Janssen
  • Kendle International
  • K-Force
  • MDS Pharma Services
  • Merck & Co
  • Novartis
  • Novo Nordisk
  • Ortho Biotech
  • Parke-Davis
  • Pfizer, Inc.
  • Pharmacia & Upjohn
  • PharmaNet, Inc.
  • PPD Development
  • Quintiles
  • REGISTRAT
  • Sanofi-Aventis
  • Takeda Pharmaceuticals
  • Wyeth-Ayerst

The Clinical Trials Unit is an outpatient center equipped with:

  • Centrifuge
  • Dedicated sub-zero freezer
  • Secure refrigerated drug storage
  • Climate controlled secure drug storage room
  • Electrocardiograms
  • Stadiometer
  • Internet Access
  • Electronic Database

The Unit uses a local IRB, the Rochester General Health System Clinical Investigations Committee, which meets twice monthly.

Quality Assurance

  • Standard Operating Procedures – annually reviewed and updated
  • Staff Certifications:
    • ACRP (Association of Clinical Research Professionals) training and CCRC (Certified Clinical Research Coordinator) certification of all study coordinators when eligible
    • Saf-t-Pak training and testing for shipment of human diagnostic specimens
    • Human Subject Protection Program (HSPP) certification through the University of Rochester
  • Weekly meetings with Study Coordinators, Investigators and research staff to review study progress
     

Staff Experience

Zachary R. Freedman, MD, FACE
Endocrinology & Internal Medicine, Primary Principal Investigator
Over 18 years clinical trial experience

R. James Bingham, MD, FACE
Endocrinology & Internal Medicine, Sub-Investigator
6 years clinical trial experience

Amy Winterberger, AAS, CCRC
Research Manager
Certified Clinical Research Coordinator
15 years clinical trial experience

Cathy Cimino, AAS, CCRC
Certified Clinical Research Coordinator
6 years clinical trial experience

Nancy MacBay, AAS, CRC
Clinical Research Coordinator
3 years clinical trial experience

Cindy Tornes, RN, BSN, CDE
Nurse / Certified Diabetes Educator
3 years clinical trial experience

Carole McClary, BSN, MSN, ANP, CDE
Adult Nurse Practitioner / Certified Diabetes Educator
3 years clinical trial experience

John Kralles, RD, MS, CDE
Dietician / Certified Diabetes Educator
3 years clinical trial experience