Therapeutic Areas

Cardiology/Vascular Diseases
Dermatology
Endocrinology
Family Medicine
Gastroenterology
Immunology
Musculoskeletal
Nephrology
Neurology
Nutrition and Weight Loss
Obstetrics/Gynecology (Women’s Health)
Ophthalmology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Sleep
Urology
Vaccines

Center Overview

Upstate Clinical Research Associates is located in Williamsville, NY, a suburb of Buffalo, NY. We are a dedicated, Multi-Therapeutic Research Center. We are committed to excellence in conducting Phase II - IV clinical research trials for our sponsors. We focus on the highest practice standards set by the industry, strict protocol adherence, impeccable compliance to Good Clinical Practice and accurate source documentation with prompt CRF completion. Our goal is to conduct high quality Clinical Research Trials. Our commitment is reflected in our rapid trail onset and attention to detail that enables us to complete enrollment in our trials in a timely, proficient manner while maintaining the highest ethical standards that ensure subject safety. All of our investigators are board certified and affiliated with the State University of New York at Buffalo (SUNY). In addition to our investigators, the center employs five study coordinators, two nurse practitioners, two research assistants, a dedicated data-entry coordinator to assure timely E-CRF completion, a recruiter and a Director of Research for regulatory documents. We believe that this experienced and extensive staff assures us and our sponsors of clean and accurate data, adherence to protocol guidelines, attention to federal regulations all while adhering to good clinical practice. We understand the needs of our subjects, sponsors and CRO's. Our investigators and coordinators believe that participation in Clinical Research puts them on the cutting edge of new therapies and is an essential part of delivering excellent health care services. At Upstate Clinical Research Associates we are committed to excellence in Clinical Research.

Performance Metrics

Number of Studies Conducted: 80
Number of Studies Actually Completed: 80
Number of Active Patients in the Database: 3000
Regulatory Submission Turn-Around Time: 3 Business Day(s)
Average Number of Total Patients Enrolled: 20
Average Percent of Total Patients Randomized: 90%
Average Percent of ‘Completed’ Studies that met Enrollment Goals: 95%
EDC Capabilities: Yes

Clinical Research Experience

Upstate Clinical Research Associates is the only independent, free-standing dedicated clinical research site in the Buffalo-Niagara region conducting Phase II, III and IV clinical trials. Our investigators and coordinators have more than 35 years of combined experience in the clinical research industry. We have an extensive database of subjects interested in clinical research participation that have demonstrated exceptional compliance. In addition, we have established a large network of referring colleagues.

We have successfully conducted clinical research trials in the following therapeutic areas:

Acid Reflux Acne Allergic Rhinitis Carpal Tunnel Chronic Constipation Chronic Pain Cold & Flu Cold Sores (Herpes Labialis) Common Cold Constipation Contraception Depression Diabetes (Type I) Diabetes (Type II) Diabetic Peripheral Neuropathy Fibromyalgia Flu Vaccine GERD Gout Heartburn Hot Flashes Hypercholesterolemia Hypertension Insomnia

Irritable Bowel Syndrome Low Back Pain Menstrual Migraines Migraine Headache Obesity Opioid Induced Constipation Osteoarthritis Osteoarthritis of Hip Osteoarthritis of Knee Over-Active Bladder Post Herpetic Neuralgia Post-Op Nausea Post-Op Vomiting Psoriasis Restless Leg Syndrome Rosacea Seasonal Allergic Rhinitis Smoking Cessation Stress Urinary Incontinence Tension Headaches Toenail Fungus Urinary Tract Infections Weight Loss

Our Research Center Has Conducted Pharmaceutical Sponsored Research With:

• Abbott Labs
• Adolor
• Advanced Tissue Sciences
• Antares
• Astellas
• AstraZeneca
• Bayer
• Berlex Labs
• Bristol-Myers Squibb
• Cephalon
• Cubist Pharmaceuticals
• Endo Pharmaceuticals
• Genentech
• Genzyme Tissue Repair
• Glaxo-Smith-Kline
• Johnson & Johnson
• Marion-Merrel Dow
• Merck
• NanoBio
• Neurogesx
• Novartis
• Pain Therapeutics
• Pfizer
• Purdue Pharma
• Sanofi
• Schwartz
• Sigma-Tau Pharmaceuticals
• Shinogi
• Sucampo
• Teva
• Wyeth
• Zogenix

Our Research Center has worked with the following CRO's:

• AAI PharmaO
• BioClinica
• Covance
• I3
• ICON
• INC Research
• KForce
• MedPace
• Novella
• Omnicare Clinical Research
• Paragon
• Parexel
• Pharmanet
• PPD
• PRA International
• Premier Research
• Quintiles
• Radiant Research
• RPS
• Scirex

Facility Description

Our Research Center conducts out-patient research studies. We have state of the art equipment and on-site services including: On site phlebotomy, -20° freezer, - 80° freezer, dedicated refrigerator for refrigerated investigational product, centrifuge, GSA Class 5 cabinet for opioid investigational product storage, Burdick ECG machine and data-scopes. We are affiliated with Buffalo Ultrasound which is located 2 miles from our facility when x-rays, ultra-sounds or CATT scans are required for research studies.

We have comfortable, private and spacious accommodations for our monitors. We know the importance of source data verification and time is set aside by our coordinators and data entry personnel to meet with our monitors at every visit.

We are located in the largest suburb of Buffalo, NY. Our facility is on a major bus route. We are easily accessible to major roads and the New York State Thruway. We are 3 miles from the Buffalo-Niagara International Airport and have numerous hotels chains in our area.

Medical Equipment

sCalibrated Centrifuge Calibrated ECG machines Calibrated Scales Climate Controlled & Secure Drug storage Freezers (-70 degree & -20 degree) Refrigerated Centrifuge Study Drug Refrigerators GSA Class 5 safe (30-man hour break-in)

Lab room with vital station Monitor room accommodates 4-5 monitors One kitchen Patient waiting room with television and reading material Separate rooms for coordinators/PI’s and data entry personnel Three exam rooms Two handicapped rest rooms

Offsite Access:

• Audiology
• Audiometry
• MRI/CT
• Neurology
• X-ray

Technology

• Additional copier in monitor room
• High speed wireless router and firewall
• Individual computers for all staff
• Server backup for all data
• Server printer, fax and copier
• Virus protection for all computers
• Wireless and hard wired high speed cable internet throughout office

Office Amenities

• 24- hour alarm and fire protection
• Climate controlled drug storage room
• Free parking

Investigator Experience

JARED C. BARLOW, MD
Medical Director of Upstate Clinical Research Associates - Principal Investigator
Board Certified in Anesthesiology
Dr. Barlow has been involved in clinical research for more than 35 years. He has had an extensive affiliation with the State University of New York at Buffalo (SUNY) as the Chairman and Executive Vice-Chair of the Department of Anesthesiology. He is also a Clinical Professor of Anesthesiology at the University. In addition, he was the Chairman of the Department of Anesthesiology at Millard Fillmore Hospitals and the Medical Director / Administrator of Millard Fillmore's Ambulatory Surgery Center. Dr. Barlow is a member of the American Society of Anesthesiologists (ASA), International Anesthesia Research Society, American Medical Association, New York State Society of Anesthesiologists (NYSSA), the former President of the NYSSA, State of New York Medical Society and the Erie County Medical Association. He has served on 15 committees at Millard Fillmore Hospital and is an active Rotarian. Dr. Barlow has given numerous presentations to his profession and has authored many publications.

JAMES E. WILD, MD
Principal Investigator - Upstate Clinical Research Associates
Board Certified in Family Pracitice
Dr. Wild joined Upstate Clinical Research Associates as an investigator in 2005. He has conducted Phase II, III and IV trials as a Principal and Sub-Investigator. He is the Associate Medical Director of TLC Network and the Medical Director at Tri-County Hospital. Dr. Wild is a member of the American Academy of Family Physicians, American Academy of Physician Executives and the Society of Teachers of Family Medicine. Dr. Wild is also active with the State University of New York at Buffalo as a Preceptor to first year medical students for an "Introduction to Clinical Medicine", a Preceptor for second year medical students for the "Rural Family Medicine" rotation, a Preceptor for third year medical students for the "Family Practice Rotation and Birth and the Family". He is a practitioner in a large family practice that refers qualified subjects into ongoing research trials conducted at Upstate Clinical Research Associates.

Connie Jozwiak-Shields, NP, PhD
Sub-Investigator - Upstate Clinical Research Associates
Dr. Shields became involved in clinical research in 2005. She has been a sub-investigator for Phase II, III and IV trials since joining Upstate Clinical Research Associates. Dr. Shields is an adult nurse practitioner with a PhD in Sociology. She has been an Assistant Professor at Trocaire College, Niagara University, State University of New York at Buffalo and D'Youville College. Dr. Shields is a member of the American College of Nurse Practitioners, National Organization of Nurse Practitioner Faculties, Sigma Theta Tau (National Nursing Honor Society), NYS Nurse Practitioners Association and the Nurse Practitioners Association of Western New York.

Kathleen Cosgrove-Drury, NP
Sub-Investigator - Upstate Clinical Research Associates
Ms. Cosgrove-Drury became involved in clinical research in 2009. She has been a sub-investigator for Phase II, III and IV trials since joining Upstate Clinical Research Associates. Ms. Cosgrove-Drury is an adult nurse practitioner with an extensive background in adult health. She is a member of numerous health organizations and has an avid interest in clinical research.

Staff Expertise

ALI STATE, BA, RN
Director of Research 25 Years of Clinical Research Experience

Maureen C. Helwig, RN
Lead Coordinator 10 Years of Clinical Research Experience

Michele Dantonio, RN
Research Coordinator 4 Years of Clinical Research Experience

Patricia Morreale
Research Coordinator 4 Years of Clinical Research Experience

Amy Strombach, BS
Recruitment Specialist 5 Years of Clinical Research Experience

Michelle Miori
Data Entry/Lab Tech 3 Years of Clinical Research Experience

Patient Demographics

Upstate Clinical Research is located in the Greater Buffalo-Niagara region. Research is a large part of the community as the State University of New York at Buffalo (SUNY) is the largest SUNY campus. In addition, Roswell Park Cancer Institute is located in Buffalo, NY and 6 University affiliated hospitals.

Our extensive subject database is compiled from participants in previous research studies we have conducted that have demonstrated compliance and interest in research. In addition, patients from Dr. Wild's private practice along with a comprehensive colleague referral network assures us of meeting enrollment goals with well qualified participants.

Our adult subject population characteristics are as follows: (we do not conduct pediatric trials)

• 63% Female
• 37% Male
• 88% Caucasian
• 12% Minorities

Our adult population age breakdown is as follows:

• 55% is between the ages of 18-60 years of age
• 45% is between the ages of 61-75 years of age
• 5% is between the ages of 76-90 years of age

Other Information

Upstate Clinical Research Associates conducts clinical research trials at the highest standards. We utilize our sponsor's central IRB unless requested to do otherwise by our sponsor. We have internal Standard Operating Procedures (SOP's) covering all aspects of clinical research conduct. Our staff meets monthly and is updated on training, study progress and continuing education. In addition our staff is trained on HIPPA and OSHA compliance. Our coordinators are IATA certified and our laboratory is New York State CLIA certified.

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.

Name:
Address:
City:
State:
Country:
Phone:
Email:
Message: