Question14. As a CRA you have been given the task of finding potential investigative sites for the clinical trial of a new drug that would treat AIDS. Please find and list 3 potential sites in the United States and give their profiles?
Answer: As a CRA I have reviewed profiles of hundreds of clinical studies sites among which I found following three sites most potential for the study of a new AIDS drug.
1)The Geneva Foundation ( USA )
Tripler Army Medical Center (Recommended site of investigation)
The Geneva Foundation was created in 1993 as a non-profit organization with the sole mission to promote and support the advancement of military medicine. Their focus is providing quality service to medical researchers and clinical trial sponsors to facilitate the successful and timely completion of research protocols nationwide. They are recognized as a leader in providing comprehensive administrative support to military medical personnel. They work with investigators in a variety of medical and surgical specialties at numerous sites located throughout the United States . These include, but are not limited to, Brooke Medical Center , Eisenhower Medical Center , Madigan Medical Center , San Diego Center , Tripler Medical Center , Wilford Hall Air Force Center , William Beaumont Center , and Walter Reed Medical Center .
The Geneva Foundation has facilitated the conduct of clinical trials in military medical institutions since 1993.The Geneva Foundation regularly connects clinical trial sponsors and qualified investigators to accomplish Phase II, III, & IV research studies nationwide . Their services in area include: Identifying research protocols appropriate for investigators and their site; Negotiating financial support and the contract on behalf of the investigator and site; Acting as a liaison between the investigator and the sponsor; Generating and submitting any documents required by the U.S. government to proceed with the protocol; Providing clinical research personnel to support all facets of the research from IRB submission and study start-up through patient recruitment and data collection to data queries and study closeout; purchasing supplies, equipment, and coordinating other necessary support; and lastly, administering funds resulting from the conduct of the research protocol.
The Geneva Foundation supports research studies in the fields of Cardiology/Vascular Diseases, Dermatology/Plastic Surgery, Endocrinology, Gastroenterology, Hematology, Immunology/Infectious Disease, Musculoskeletal, Nephrology/Urology, Neurology, Obstetrics/Gynecology, Oncology, Ophthalmology, Otolaryngology, Psychiatry/Psychology, Pulmonary/Respiratory Diseases, Rheumatology, and Trauma/Emergency Medicine. The Geneva Foundation has worked with a variety of pharmaceutical companies and Clinical Research Organizations, to include Mitek Products, Merck, Bristol-Myers Squibb, Ocularis Pharma, Kendle, King Pharmaceuticals, Pfizer, American Medical Systems, Parexel International, GlaxoSmithKline, Fujisawa Healthcare, Anthra Pharmaceuticals, ILEX, Health Decisions, Paragon, Novartis, Covance, AstraZeneca, Ortho-McNeil, Proctor & Gamble, Boehringer Ingelheim, Catalyst Pharmaceutical Research LLC, Abbott Laboratories, VIVUS, Pharmacia, KCI, ALZA Corporation, ACOSOG, ICOS Corporation, Quintiles, PPD, Aventis, Amgen, Wyeth and many more.
The Geneva Foundation has experience conducting research studies in the following therapeutic areas:
Tripler Army Medical Center
- HIV Clinic
- Internal Medicine
- Pediatric Oncology
- Cardiothoracic Surgery
- Diabetes Management
- General Surgery
- General Surgery Residency
- Infection Management
- Orthopaedic Surgery
Jane Taylor – Founder & Chairman of the Board, Corporate Staff; 20 years clinical trials experience
Elise Huszar – President, Corporate Staff; 10 years clinical trials experience
Troy Christensen – Executive Director, Corporate Staff; 1 year clinical trials experience
Andrea Lee – Clinical Trials Director, Corporate Staff; 11 years clinical trials experience
Patti Walker-Hickey – Clinical Trials Specialist, Corporate Staff; 6 years clinical trials experience
Karol Barstow – Clinical Research Manager, Tripler Army Medical Center 18 years clinical trials experience
Cheryl Jarman – Clinical Research Manager, Tripler Army Medical Center 15 years clinical trials experience
Sandra Gilbert – Clinical Research Coordinator, Tripler Army Medical Center 24 years clinical trials experience
Denise Harris – Clinical Research Coordinator, Tripler Army Medical Center 11 years clinical trials experience
Yeini Thompson – Clinical Research Coordinator, Tripler Army Medical Center 12 years clinical trials experience
Erinn Morris – Clinical Research Coordinator, Tripler Army Medical Center 1 year clinical trials experience
Tammy Scott – Clinical Research Coordinator, Tripler Army Medical Center6 years clinical trials experience
Julie Burr – Research Regulatory Specialist Tripler Army Medical Center 3 years clinical trials experience
The Geneva Foundation is dedicated and built on the following values 1) Integrity, Superior Service to Customers, and Respect to All. The Geneva Foundation remains dedicated to seeking innovative ways to improve the future of medicine.
2) Boston University Medical Center
Clinical Research Experience
BU center has been involved in clinical research for over 50 years. They conduct research in all Study Phases.
BU Medical Center specializes in the following therapeutic areas:
- Infectious Disease/AIDS
They have worked with most major pharmaceutical companies as well as the following CROs:
- and many others
They have more than 100 clinical investigators in most therapeutic areas.
- Urban patient population
- Diverse demographics and socioeconomic profile
- IRB meets 4 times/month
- Site uses Remote Data Entry
- Center has numerous centers of excellence in such areas as cardiovascular disease, hypertension, infectious diseases and in women’s health
Director, Office of Clinical Research
Boston University Medical Center
715 Albany Street
Boston, MA 02118 USA
3) Arizona Research Center
Arizona Research Center is a free-standing, independent clinical research organization. Founded by board-certified orthopedic surgeon Joseph S. Gimbel, M.D., in 1997, the organization has grown to become one of the state’s leading research organizations.
Clinical Research Experience
Arizona Research Center, founded in 1997, primarily conducts phases II, III and IV studies, and has extensive and diverse research experience. Sponsors include, but are not limited to:
- Asta Medica
- Bristol Myers Squibb
- Eli Lilly
- Johnson & Johnson
- Neurocrine Biosciences
- ONO Pharma
- Pain Therapeutics
- Parke Davis
- Personal Product
- Proctor & Gamble
- Purdue Pharma LP
- R.W. Johnson
- United Therapeutics
Multiple CRO’s have worked with Arizona Research Center . Among them are:
- Bailer Research
- B & B Clinical Investigators
- INC Research
- Ingenix/i3 Research
- Rheumatology Research International
Arizona Research Center has two Orthopedic Surgeons and an Internist as Principal Investigators, providing expertise over numerous therapeutic areas:
- Cardiology / Vascular Surgery
- Dermatology / Plastic Surgery
- Immunology / Infectious Disease / HIV
- Nephrology / Urology
- Psychiatry / Psychology
- Pulmonary / Respiratory Disease
- Trauma / Emergency Medicine
Arizona Research Center’s regulatory specialists process the start-up paperwork rapidly and work diligently to maintain all regulatory documents throughout the study.
Principal Investigators and Study Coordinators are aided in study enrollment and recruitment through the work of the business development staff. These employees work diligently to pursue all avenues of patient recruitment and help the Research Center to frequently exceed enrollment standards set by study sponsors.
Clinical Research Coordinators
Arizona Research Center CRC’s work under the direction the PI in the overall, day-to-day management of clinical trials. Team leaders with extensive research experience oversee each coordinator, who can efficiently manage multiple trials.
Arizona Research Center
2525 W. Greenway Rd., Suite 114
Phoenix, AZ 85023 USA
E-mail: [email protected]