The CAMC Institute Clinical Trials Center is a centralized clinical research center dedicated to research full-time, and is affiliated with West Virginia University, providing superior patient care and clinical trial performance. The Center is experienced in conducting Phase II-IV clinical trials evaluating a myriad of therapeutic areas. It gives area patients access to investigational drugs, innovative procedures, and new therapies, reducing their need to travel outside West Virginia for care. Some highlights of the Center are:

• Research staff is available 24 hours a day, seven days a week, for protocol-specific patient care.
• Complete adherence to FDA regulations
• Protocol adherence
• In full compliance with GCPs and GLPs
• Complete set of SOPs
• Our clinical investigators are board-certified and our organization is well versed in FDA regulations and guidelines.
• Secured investigational drug service space and drug storage
• Secured storage space for case report forms and other study-related documents
• Computerized patient database
• Computerized multi-disciplinary investigator database
• CLIA- and CAP-approved laboratory (CAMC)

The CAMC Institute is a CAMC, Inc., subsidiary, which includes hospitals, primary care facilities, subspecialty practices, a university affiliation, a children's hospital, and nursing homes. We can provide virtually any patient population in a variety of settings. Because of our affiliation with Charleston Area Medical Center, we have access to over 550 physicians and surgeons.

About 80% of the Center's studies come from industry or cooperative groups, including the National Cancer Institute's network affiliates. The remaining 20% are generated by local investigators. The Center is involved in many national, multicenter studies.

The CAMC Institute Clinical Trials Center provides a focused mechanism for evaluating new drugs and drug uses, new medical devices, and quality of life aspects associated with the use of these products. These studies are conducted within our own facilities as well as at hospitals, clinics, and physicians' offices. The Institute plays an essential role in encouraging and supporting quality research in a controlled medical setting.

The CAMC Institute Clinical Trials Center is an obvious choice for today's researcher. Our current involvement includes clinical trials of drugs and devices, prevention programs, outcomes/quality improvement, and quality of life studies. We conduct both industry-sponsored and federally funded clinical trials. These projects have been implemented in a variety of therapeutic areas including cardiology, oncology, infectious diseases, endocrinology/metabolism, gynecology, surgery, and device development.

The Center also offers centralized management for clinical trials, providing a single point of contact to sponsors and contract research organizations. In addition, a centralized institutional research and grants review office is available for prompt human subject and contract review.

West Virginia statistics indicate that the state's rates of heart disease and stroke mortality have been higher than the national average for the past three decades, and the gap between the state and nation continues to widen. Helping CAMC, Inc., reduce these dismal statistics is central to the Clinical Trials Center's mission. Recent efforts aimed at reducing cardiovascular morbidity and mortality have attracted studies on reducing restenosis rates after angioplasty and treating patients with unstable angina and MI.

We are interested in conducting research that will benefit the people of West Virginia. The application of what we learn from research is vital to the improvement of the health, quality of service, and patient care throughout West Virginia. As a system, we at CAMC, Inc., are dedicated to providing the latest in new therapies and applications. As professionals in a growing research testing center, we make our facilities and resources available for clinical research studies.

Through research, education, intervention, and health promotion, we can change lives and improve the health of the people we serve. Services performed by the CAMC Institute Clinical Trials Center are multifaceted, improving health care opportunities for CAMC, Inc., professionals, and patients. Research projects support CAMC, Inc., focus on health promotion and prevention.

CAMC Institute's Clinical Trials Center has established a reputation for conducting clinical trials efficiently and effectively. Our investigators are experienced with clinical trials and have a broad range of specialties. We also have experienced certified clinical research coordinators, research nurse coordinators, research assistants, and support staff. Biostatistical assistance and study analysis is available through the CAMC Institute, as well as research assistance for preparation of institutional review board and other regulatory documentation. We are also very experienced in budget preparation and study implementation.

Our patient referral base and our continually expanding computerized database assure rapid patient screening and enrollment. Our affiliations with hospitals, clinics, managed care, extended care facilities and private physicians help to provide an aggressive, cost-efficient approach to patient recruitment.

All studies are conducted by trained coordinators and investigators according to rigorous quality standards.

Research Support Services:

• Patient recruitment and follow-up
• Centralized site management for clinical trials
• Experienced and certified study coordinators
• Core research support staff
• Preparation for site qualification
• Study implementation
• Study analysis
• Research assistance for preparation of IRB and regulatory documents
• Identification of research opportunities
• Study recruitment
• Referral education
• Advertising
• Teaching/in-service of staff nurses, physicians, allied health, and patients and their families
• Data collection and management; data storage
• Electronic Case Report Form compatibility
• Study medication and study device responsibility; pharmacy liaison

The CAMC Institute Clinical Trials Center, with its affiliation to Charleston Area Medical Center (CAMC), West Virginia's largest health care provider, and West Virginia University, is an obvious choice for today's researcher. CAMC is fully accredited by Joint Commission for the Accreditation of Health Care Organizations (JCAHO). In addition, the medical center is affiliated with many other hospitals and health care facilities throughout the state and serves southern West Virginia's population of more than 500,000. Demographically, the population is broadly distributed among all age, education, and income groups. We have the capabilities of conducting outpatient studies within the CAMC Institute Clinical Trials Center. The center is equipped with full service exam rooms and laboratory, an EKG machine, locked storage for investigational drugs and devices, refrigerator for temporary storage of drug and/or specimens, and secure storage for CRFs. In addition, we are able to conduct inpatient studies at Charleston Area Medical Center. CAMC is a 900-bed full service hospital with a dedicated Investigational Drug Pharmacist. Geographically, we are five minutes from Yeager Airport, and 2-4 hours from several major cities, including Pittsburgh, Columbus, and Cincinnati.

Kristi Sutphin
Operations Manager
CAMC Institute
Clinical Trials Center
3100 MacCorkle Avenue, S.E.
Suite 306
Charleston, WV 25304
USA
304-388-9945
304-388-9935 (fax)
kristi.sutphin@camc.org