Research Division

Consultants for Clinical Research (CCR) is a multi-specialty research facility that has been involved in clinical research evaluating new investigational and existing medications, as well as medical devices for over 18 years. We believe that providing the patient with alternatives for therapy, quality care, and education are important aspects of patient care.

Visit Consultants for Clinical Research on the web at www.ccrstudy.com

What is clinical research?

When a Pharmaceutical Company has a new investigational medication or one that is already approved but to be given for a new condition or at a new dose, a study is designed to collect information to prove that the medication is safe and effective. Your doctor may ask you if you are interested in participating in a study. The reasons for suggesting this may be many. Sometimes conventional treatments may not be appropriate for your condition or your doctor feels that your participation in the study may provide you more thorough follow-up as required by the study. Whatever the reasons, you should ask why he/she has asked you to consider being in a study. There may also be other reasons why you will be asked to be in a study.

How do I find out more about the study?

Your doctor will provide you with information about the study and introduce you to a study coordinator (this individual is responsible for conducting the study under your doctor's supervision). Together they will go into detail about your illness and the various treatment options. The study will be discussed in more detail and a copy of the informed consent will be reviewed with you. A copy of this consent will be given to you to take home and read. You should also understand that your participation is voluntary and if you should decide not to participate in a study, you will not be penalized in any way nor will your standard of care be affected.

What types of studies are performed?

We often have studies looking at the following conditions:

• Ulcerative Colitis

• Irritable Bowel Syndrome (IBS)

• Crohn's Disease

• Hepatitis

• Peptic Ulcer Disease

• Erosive Esophagitis

• Reflux Esophagitis (GERD)

• Dyspepsia

• Gastroparesis

• Helicobacter Pylori treatments

• Pain Management

• Osteoarthritis

• Diabetes

• Rheumatoid Arthritis

• Bronchitis

• Pneumonia

• Ear Infection

• Hemorrhoids

If you would like more information on any of these studies or future studies, contact us at (513) 872-4549 or e-mail us at info@ccrstudy.com or visit our website, www.ccrstudy.com

What happens next?

Once you have made your decision to participate in the study a coordinator will be assigned to your care and will work directly with your doctor (we call this the research team). It will be the coordinators responsibility to schedule and be present at all study-related appointments and procedures. It is very important that you answer all questions truthfully and trust this person. The research team will be asking information about your past and present medical history, medications, social history and other information required by the study. It is important that you keep them updated about visits to other physicians or changes in your medications while in the study. The team will also be available to answer any questions or talk with you about any problems day or night as needed.

What is Informed Consent?

This is a form that you will be asked to sign should you choose to participate in the study. It is a process by which you voluntarily agree to participate, after all aspects of the study are explained and all your questions have been answered to your satisfaction.

What types of studies are there and what is a placebo?

There are several types of studies that the FDA (Food and Drug Administration) and the Pharmaceutical Company (the organization that is sponsoring the study) have agreed to perform. Some are "Blinded/Masking" and others are "Comparator". The informed consent title will tell you which type of study you are being asked to participate in.

• Blinded/Masking: Single-blind usually refers to you not knowing which treatment you will receive. Double-blind usually refers to you, your doctor, and perhaps others not knowing which treatment you will receive.

• Comparator: This can be an investigational or marketed product, or placebo. Investigational is the medication or placebo being tested or used in the study. Placebo is an inactive substance that looks identical to the medication being studied and is assigned by chance or like a flip of the coin.

Once you have completed the study?

All information gathered during the study will be provided to your family doctor and other doctors upon your request. If additional treatment for your medical condition is needed, you will be advised on whom to see for follow-up. The research team will no longer be needed to coordinate your care but we will still be available for questions or concerns if the need should arise.

Fact Sheet

Professional, Knowledgeable, Experienced Research Staff

Our staff consists of eight full-time research coordinators, three of which are certified in clinical research. We have Physicians who are board-certified or board-eligible in their respective fields and Physician Assistants dedicated to research activities. Our staff is dedicated to quality patient care and education.

We have successfully completed over 300 clinical trials with numerous pharmaceutical companies and contract research organizations (CRO) in the following areas:

• Gastroenterology

• Hepatology

• Rheumatology

• Orthopedics

• Endocrine

• Family Practice

• Pulmonary

• Cardiology

• Gynecology

Our research team is experienced with all aspects of clinical investigations and has a thorough knowledge of FDA regulations and ICH guidelines.

We have an excellent Internal, Sponsor, and FDA audit record.

Facilities

• Comfortable, spacious, equipped office space with locked drug storage area all maintained in accordance with FDA guidelines.

• Outpatient Ambulatory Surgical Center onsite with state of the art equipment.

• All study records are easily accessible and maintained on site.

• Computerized database of over 125,000 patients.

• Physicians affiliated with all thirteen (13) area hospitals.

Timely Enrollment Completion and Data Submission

• Regulatory document completion within two weeks.

• Ability to utilize central or local Institutional Review Boards.

• Rapid patient recruitment.

Highest Quality Data

• Study specific source documentation insures accurate and thorough collection and verification of information.

• Strict protocol adherence.

• Prompt data entry and case report form corrections

• Quality Assurance audits on all data.