Research Site Profile

Research Site Introduction:

O.C.Research is YOUR Partner for Innovative Health Care Services:

At Optimum Clinical Research, Inc. (OCR) we consider Patient Safety and Education a priority. Our patients are provided with ongoing education on the nature of their disease and are guided through the study with valuable information about treatment options. We consider the patient-physician interaction to be vital in the healthcare process and are grateful that research provides a platform for the time and attention that every patient deserves. The OCR staff is a dedicated team of experienced research professionals: physicians, nurses and clinical research coordinators. We take pride in conducting research to the highest standard and have earned a reputation from the top 20 pharmaceutical companies for attention to detail and exacting study implementation.

Research Site Description:

Our Staff:
Dr. Jackson M. Rhudy is the Medical Director and co-founder of Optimum Clinical Research, Inc. A three-time board certified physician with an Emergency Medicine specialty, Dr. Rhudy is passionate about improving patient care. As principal investigator on more than 150 clinical trials, his experience and expertise are unmatched.

Dr. Rhudy believes that the key to a successful research site and patient care revolve around education. He is 100% dedicated to research and provides regular training to his staff and patients on the nature of disease and treatment options. His generous nature has improved the quality of life of many patients and ensured the success of his medical staff.

Jackson M. Rhudy, MD
Medical Director and Principal Investigator
PI Clinical Trial Experience: 28+ years

Imran Zubair, MD
Sub Investigator
Clinical Trial Experience: 5+ years

Heather Turner, BS, CCRC
Site Director
Clinical Trial Experience: 15+ years

Sally Quinn, BS, CCRC
Quality Assurance Manager
Clinical Trial Experience: 16+ years

Ashlee Fawson, CCRC
Clinical Manager
Clinical Trial Experience: 5+ years

Holly Wilson, LPN
Lead Research Coordinator
Clinical Trial Experience: 9+ years

Amber Palmer, BS
Recruitment Manager
Clinical Trial Experience: 5+ years

Facility Resources:

• Principal Investigator is on site daily
• Dedicated Monitoring/CRA Space (2 separate offices)
• Secure Drug Storage Area with limited access and double lock storage system and temperature control
• 5500 square foot facility with separated patient and staff work spaces
• 6 exam rooms
• Secure Records Retention Area on-site
• Dedicated fax line
• High Speed Internet & Email Access
• Diabetic Nutritionist on Staff
• OCR has a Federal Wide Assurance (FWA) number for government funded trials
• Integrated with an internal medicine group with a large database of 35,000+
• Fully stocked laboratory and equipment
• Highly Trained staff: HIPAA, OSHA, GCP

Facility Access:

• OCR is located within 15 minutes of Salt Lake International Airport
• Public Transportation access on same city block
• Free Parking
• Site is easily accessible to patients and study monitors
• Salt Lake Regional Medical Center (Hospital) is located within 50 yards. This allows OCR access to a wide range of specialties.
• SLRMC provides access to Diagnostic X-Ray
• SLRMC provides access to High- Resolution Computerized Axial Tomography

Laboratory:

• CLIA waived Laboratory
• OSHA trained staff
• IATA trained staff
• Hazmat trained staff
• 3 Phlebotomists on site
• Pharmacokinetic (PK) experience
• Pharmacogenetic (PG) experience
• Gram stain experience
• Spirometry

Equipment:

• All equipment is calibrated annually
• -20º C Freezer (temperature controlled)
• -70º C Freezer (temperature controlled)
• 2 Ambient Centrifuges
• Refrigerated Centrifuge
• Temperature controlled refrigerator
• On site dry ice machine
• ECG machine
• Automated Electronic Defibrillator
• Crash Cart
• Oxygen
• Emergency medications
• Calibrated Electronic Blood Pressure Cuffs
• Calibrated Mercury Blood Pressure Cuffs
• Diagnostic X-ray: Salt Lake Regional Medical Center located in vicinity
• Access to High-Resolution Computerized Axial Tomography

Patient Demographics:

The RESEARCH Experience

What is Clinical Research?
Choosing to participate in a clinical trial is an important personal decision. It is often helpful to talk to your physician, family members, or friends about deciding to join a trial. After identifying some trial options, the next step is to contact the study research staff and ask questions about specific trials.

Clinical research involves the introduction of a new investigational product into humans and the subsequent studies conducted to evaluate the safety and efficacy of that product. All Food and Drug Administration (FDA) approved medicines from pain killers to antibiotics have to undergo extensive research and testing before they reach the public health systems. It is at the final stages of this research that volunteers are needed from the community to participate in these trials.

Why should I VOLUNTEER?
Clinical research offers an opportunity to participate in the study of new pharmaceutical drugs that are in the development pipeline. In exchange for your participation in a clinical trial, you will receive medical care for the condition under study, medication, and comprehensive evaluation, all at no charge. In most cases you will be compensated for your time and effort.

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. In any event, you will have the satisfaction of participating in something that may not only benefit yourself, but society as well. Optimum Clinical Research, Inc. makes the process of participation easy and efficient.

Who can PARTICIPATE in a clinical trial?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called 'inclusion criteria' and those that disallow someone participating are called 'exclusion criteria. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure researchers will be able to answer the questions they plan to study.

What are the BENEFITS of participating in a clinical trial?
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

• Play an active role in your own health care.
• Gain access to new research treatments before they are widely available.
• Obtain expert medical care at leading health care facilities during the trial.
• Help others by contributing to medical research.

What are the RISKS of participating in a clinical trial?

• The experimental treatment may not be effective for the participant.
• The study design may require more of their time and attention than other forms of treatment, including trips to the study site, more treatments, or complex dosage requirements.
• Though unlikely, there may be unpleasant side effects to experimental treatment.

* Our staff will ensure that you are fully informed about the study medication PRIOR to and throughout study participation.

Additional Information:

How will PARTICIPANT SAFETY be PROTECTED?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants.

To Our Sponsors/ Pharmaceutical Companies and CRO’s:

At Optimum Clinical Research, Inc. we are dedicated to the pursuit of excellence in all areas of clinical research from patient care to data collection.

Optimum Clinical Research, Inc. is a privately owned, independent research company located in a medical professional building on the campus of Salt Lake Regional Medical Center in Salt Lake City, Utah.

This excellent placement provides convenient access to multiple specialties and to the full range of medical services needed for high quality research. OCR provides comprehensive facilities for the conduct of clinical research in a comfortable, yet professional environment. Every member of the Optimum Clinical Research team, from the physicians to the study coordinators, is focused on providing each study participant with the medical care and attention they deserve. Many OCR study participants find that they learn more about their disease and become educated on better nutritional, diet and exercise habits.

OCR has been conducting clinical research studies in multiple specialties since 1999 and has successfully completed over 150 industry sponsored drug clinical trials in phases II –IV.

OCR’s experience in clinical trials includes the areas listed below:

• Cardiovascular: angina, cardiovascular disease, hypertension
• Endocrinology: diabetes mellitus type I and II, lipid disorder, obesity, thyroid disorder
• Gastrointestinal: GERD, IBS
• Immunology: hepatitis, meningitis, RSV, HIV
• Musculoskeletal: low back pain, osteoarthritis, rheumatoid arthritis, osteoporosis
• Neurology: fibromyalgia, migraine, pain, Parkinson’s Disease, sleep disorder
• Pulmonary: asthma, bronchitis, pneumonia, COPD (chronic bronchitis, emphysema)
• Psychiatry: anxiety, depression
• Rheumatology: arthritis
• Urology: erectile dysfunction, prostatitis, UTI
• OB/GYN: menopause
• Other: pharyngitis, sinusitis

Contact Information:

www.OCResearch.com

Optimum Clinical Research
82 South 1100 East, Suite 402
Salt Lake City, UT 84102
Phone: (801) 363-7353
Fax: (801) 363-7574
Email:admin@ocresearch.com