Rochester Clinical Research (RcR) is a dedicated clinical research center providing clinical research services to the pharmaceutical and medical device industries. RcR’s experienced clinical research personnel engage the patient and their primary care physician to become informed partners in every clinical trial.

With over twelve years of successful clinical trials experience, RcR has established a reputation for reliability and expertise having conducted over 450 Phase II, IIb, III, IIIb, and IV clinical studies in the therapeutic areas of:

• Bone Densitometry
• Diabetology
• Eating Disorders
• Endocrinology
• Family Medicine
• Hyperlipidemia
• Hypertension
• Gastroenterology
• Geriatrics
• Gynecology
• Internal Medicine
• Men’s Health
• Musculoskeletal & Connective Tissue Disorders
• Obesity
• Ophthalmology
• Pain Management
• Rheumatology
• Smoking Cessation
• Vaccines
• Women’s Health

RcR Facts

• RcR provides outpatient services in a 9,000 square foot modern facility and has climate controlled secure drug storage rooms, dedicated monitor rooms with high speed broadband for RDE(remote data entry) access, and on-site long term storage.
• RcR has the ability to use a central IRB when required to accommodate individual sponsor requirements
• RcR maintains a Patient Tracking System. RcR staff are experienced with RDE
• RcR has an established Internal Audit Program to ensure protocol compliance
• Patient recruitment is typically achieved by the following means:
  • Excellent community wide recruitment program
  • Over 13,343 patients in RcR’s database, and over 20,000 patients in each of the referring physicians private practice databases.
  • Physician referrals from large Rheumatology, Dermatology, Gastroenterology and Gynecology private practices
  • Advertising: television, newspaper, radio, direct mail, community posters
  • Periodic newsletter delivered to patient database, and established mailing lists that are sorted by therapeutic areas.
  • E-Newsletter on website Rcrclinical.com

Allergy Allergic Rhinitis Cardiovascular Essential Hypertension Dermatology Herpes Zoster Herpes Labialis Endocrine/Metabolism Dyslipidemia Dyslipidemia in NIDDM Hormone Replacement Therapy Diabetes Mellitus Obesity Obesity in NIDDM Men’s Health Care Erectile Dysfunction Musculoskeletal/Rheumatology Osteoarthritis Rheumatoid Arthritis Osteoporosis Fibromyalgia Gout Neurological Migraine Headache, Adult Insomnia Pain Acute Low Back Pain Chronic Back Pain Neuropathy Pain due to Osteoarthritis Chronic Pain Syndromes Shoulder Pain

Gastroenterology Erosive Esophagitis Duodenal Ulcer & Gastric Ulcer Gastric Protection (NSAIDS) Gastroesophageal Reflux Disease (GERD) Heartburn Irritable Bowel Syndrome (IBS) Non-Ulcer Dyspepsia Infectious Diseases Acute Sinusitis Acute Bronchitis Pneumonia Medical Devices Device for Osteoarthritic patients Osteoarthritis exercise device Osteoarthritis injectable Smoking Cessation Nicotine replacement RX to OTC Trials Oral Agents Respiratory Acute Bronchitis Asthma Women’s Health Care Hormone Replacement Therapy Genital Herpes Irritable Bowel Syndrome in Women Contraception Birth Control Pills Birth Control Patch Insomnia/menopause symptoms PMDD Female Sexual Arousal Disorder PMS

Diagnostic/Clinic Equipment

EKG Centrifuge Refrigerated Centrifuge Stadiometer Spirometry 24 hour ambulatory BP monitoring equipment

-20° Freezer DXA Densitometer - Lunar Prodigy Arterial Compliance Monitor Cholestech Analyzer Phlebotomy Station Refrigerated Drug Storage

Facility

• Climate controlled secure drug storage rooms
• Dedicated monitor rooms with remote data entry capability
• Easy access off major expressway for patients and sponsors
• On-site long term storage

Five [5] Investigators who are board certified in Internal Medicine, Rheumatology and Family Practice, with interest and expertise in multi-therapeutic areas.

Mervyn Weerasinghe, MD
Mweerasinghe@rcrclinical.com
Internal Medicine, Medical Director and Primary Principal Investigator
Principal Investigator or Sub-Investigator on more than 325 clinical research studies with over thirteen years experience conducting research. Dr. Weerasinghe is board certified in Internal Medicine and has extensive practice experience in a managed care setting. He was the Medical Director for an HMO for eight years, of a hospital for seven years, and of a multi-specialty group practice for 10 years. He has served as Principal Investigator or Sub-Investigator in the areas of hypertension, diabetes, obesity, hyperlipidemia, asthma, osteoarthritis, hormone replacement therapy, smoking cessation, peptic ulcer disease, and contraception.

Matthew Davis, MD
Mdavis@rcrclinical.com
Family Practice, RcR Associate Medical Director
Principal Investigator or Sub-Investigator on more than 300 clinical research studies. Dr. Davis has held the position of Chief Physician for an after hours medical care division of a Rochester health care provider. His clinical research experience includes studies in erosive esophagitis, herpes labialis, osteoarthritis/RA, sinusitis, dyspepsia, IBS, erectile dysfunction, cholesterol, diabetes, and contraceptives.

Tammi Shlotzhauer, MD
Tshlotzhauer@rcrclinical.com
Rheumatology & Internal Medicine, Assistant Medical Director
Dr. Shlotzhauer is a practicing rheumatologist and the Assistant Medical Director of RcR who is board-certified in both internal medicine and rheumatology. She has been involved in over 210 clinical trials and has served as a consultant for protocol development. Dr. Shlotzhauer has held positions as Chief Physician of a rheumatology division at a local hospital, Medical Director of a local medical group and Chair/Advisor for a local medical group’s management and quality division. She is also a partner in a successful Rheumatology practice located in our building. Her interests include osteoporosis, OA, RA, fibromyalgia, collagen vascular disorders and pain syndromes, as well as common internal medicine diagnoses.

Keith Pryhuber, MD
Kpryhuber@rcrclinical.com
Rheumatology & Internal Medicine, Associate Medical Director
Dr. Pryhuber is a practicing rheumatologist who is board-certified in both internal medicine and rheumatology. He has participated in over 190 clinical trials and is partner in a successful Rheumatology practice located in our building. His interests include OA, RA, fibromyalgia, and osteoporosis, as well as common internal medicine diagnoses.

Michael Brennan, FNP
mbrennan@rcrclinical.com
Family Practice, RcR Sub-Investigator
Michael Brennan, FNP, has 15 years of clinical experience working in local Family Practice, Urgent Care, and Emergency Medicine. He has also been involved in the training and clinical preceptorship of Nurse Practitioners. Michael’s areas of research interest include hypertension, diabetes, and hypercholesterolemia.

MANAGEMENT

Patricia Larrabee, RN, NP, CCRC
Plarrabee@rcrclinical.com
Founder and Chief Executive Officer
Ms. Larrabee, who has been extensively involved as a Sub-Investigator in over 465 clinical trials for over 26 years, founded RcR in 1994 to provide residents of the Greater Rochester area access to research studies. Her clinical experience as a researcher and lecturer on high blood pressure, as well as her relationship with local physicians in a managed care setting, provided an opportunity to conduct research with a varied patient base. RcR has conducted over 450 trials in many therapeutic areas due to Ms. Larrabee’s high-energy, compassionate and detail oriented approach to research.

Clinical Staff	Years in clinical research
Patricia Larrabee, R.N., N.P., CCRC	26
Barbara Jones, R.N., CCRC	10
Donna Willome, R.N., N.P., CRC	6
Christine Kelly, R.N., CCRC	6
Therese Dayton, R.N., CCRC	6
Sally Cardella, R.N., CCRC	6
Phyllis Howe, R.N., CRC	6
Victoria Fink, RD, CDE	6
Anne Cutter, RN, CRC	1
Lisa Wishard, RN	1
Jamie Burleson, RN	1

• Prior to joining RcR, our nurse coordinators have held positions as study monitors, or in hospital or office practices.
• We provide funding and training for all of our coordinators to become ACRP certified clinical research coordinators (CCRC).

Other Staff

• Medical Assistants
• Phlebotomists
• Patient recruiters
• Regulatory affairs specialist
• Remote data entry specialist

Programs/Certifications

• Comprehensive new-staff training, mentoring, and Continuing Education programs
• RcR’s Good Clinical Practices (GCP), Standard Operating Procedures (SOP) and internal audit program we can assure your company of the necessary requirements for excellent patient care and data collection.
• ACRP training and CCRC certification of all Study Coordinators when eligible
• FAA certified staff for the shipment of hazardous materials
• HIPAA compliance and OCR Regulations training
• Credentialing Program for Investigators
• OSHA compliant
• New York State CLIA Certified Limited Service Laboratory

• RcR is located in Rochester, New York, which is known as a world leader in the development of photographic and communications equipment, optics and laser graphics, biotechnology, and is the home to such multinational high tech companies as Kodak, Bausch & Lomb, and Xerox. Over 60% of the adult population is college educated.
• The Metropolitan area, which includes Monroe County and portions of five other counties, has a population of over 1.2 million people
• Over 13,343 patients in RcR’s database and over 20,000 patients in each of the referring physicians private practice databases. RcR’s patient database is comprised of 60% female and 40% male patients. The age breakdown is:

Age Group	# Female	# Male
25+	6925	4061
25-50	2733	1256
50-80	3920	2587
> 50	4193	2821
< 50	2994	1853

Industry Sponsors

3M Abbott Laboratories Altana Alza Alteon Amgen Inc. Amylin Corporation Andrx Astra Merck Astra Pharmaceuticals Astra Zeneca Aura Laboratories, Inc. Aventis Barr Bayer Corporation Berlix Biovail technologies Ltd. Boehringer Ingelheim Bristol-Myers Squibb Byk Gulden Cipher Covalent Research Alliance DepoMed Duramed Eisai Entropin Eli Lilly & Co. Fisons Forest Labs G. D. Searle Pharmaceuticals Genaissance Genentech, Inc. Glaxo-Wellcome GlaxoSmithKline Hoechst Marion Roussel Hoffman LaRoche Johnson & Johnson

Knoll Pharmaceutical Company Medivir Merck Human Health Division Merck Research Laboratories Mitsubishi NiCox Novartis Novo Nordisk NPS ObeCure Ortho-McNeil Pharmaceuticals, Inc. Parke-Davis Pharmaceuticals Pfizer Inc. PPD Pharmacia & Upjohn Preventive Medical Technologies Purdue Pharma Radius Health, Inc. Regeneron R.W. Johnson Pharmaceutical Research Institute Rhone-Poulenc Rorer Roche Laboratories Sankyo, USA Sanofi-Synthelabo Schering Plough Searle Sepracor, Inc. Smith-Klein Beecham Solvay Pharmaceuticals Inc. Takeda America, Inc. TAP Holdings Inc. Therimmune Transport Tularik Upsher-Smith Vector Watson Winston Wyeth Ayerst Zeneca Pharmaceuticals

Contract Research Organization Sponsors

Acurian Advanced Biologics Barton and Polansky BioPharm Celeris Clinimetrics Research Associates ClinTrials, Inc. Concepts in Pharmaceutical Research (CPR) Covalent Research Alliance, Inc. Covance Global IQ IBRD/Phoenix ICON INC Research Ingenix Innovex, Inc.

Integrated Research Kendle International MedPace MTRA Omnicare Paragon Biomedical Inc. Parexel International Corporation Pharmaceutical C-Trials Pharmaceutical Research Associates (PRA) PharmaResearch PPD Pharmaco PPD Development Pharmakenetics, Inc. PharmaNet, Inc. Quintiles, Inc.

Rochester Clinical Research has been chosen by the residents of Rochester as the BEST Clinical Research Site in Rochester for five years in a row - 2002, 2003, 2004, 2005 and 2006

RcR was also awarded a TOP 100 Company in the Rochester Region award from the Rochester Business Alliance and the Chamber of Commerce for 2003 & 2004

CenterWatch is listing the following trials that are actively recruiting patients at this center.

• Are you interested in an Investigational Pneumococcal Vaccine Research Study?
• Diabetes - Diabetic Neuropathy
• Do you have High Cholesterol?
• Insomnia
• Men and Women 60 and over interested in a shingles vaccine research trial?
• Painful Osteoarthritis of the Knee?
• Trial Information: Weight Loss / Diabetes
• Type 2 Diabetes
• Type 2 Diabetes
• Vaccine for Shingles
• Weight Loss

For more information, please contact:

Patricia Larrabee, RN NP, Founder & CEO
Rochester Clinical Research
500 Helendale Rd, Suite L20
Rochester, NY 14609 USA
Phone: 585-288-0890
Fax: 585-288-0893
E-mail:

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the E-mail form below. A representative from the research center will then follow up with you.

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Last updated on August 27, 2008