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?

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 .

Clinical Research Experience

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.

Investigator Experience

The Geneva Foundation has experience conducting research studies in the following therapeutic areas:

Tripler Army Medical Center

• Cardiology
• HIV Clinic
• Internal Medicine
• Pediatric Oncology
• Cardiothoracic Surgery
• Diabetes Management
• General Surgery
• General Surgery Residency
• Hematology/Oncology
• Infection Management
• Ophthalmology
• Orthopaedic Surgery
• Pathology

Staff Expertise

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

Other Information

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:

• Trauma
• Surgery
• Dermatology
• Cardiovascular
• Pulmonary
• CNS
• GI
• GU
• Renal
• Infectious Disease/AIDS
• Hematology-Oncology
• Pediatrics
• Rheumatology

They have worked with most major pharmaceutical companies as well as the following CROs:

• Parexel
• Covance
• Quintiles
• PPD
• Pharmaco
• and many others

Investigator Experience

They have more than 100 clinical investigators in most therapeutic areas.

Patient Demographics

• Urban patient population
• Diverse demographics and socioeconomic profile

Other Information

• 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

Contact information:

Director, Office of Clinical Research
Boston University Medical Center
715 Albany Street
Suite A-206
Boston, MA 02118 USA
Phone: 617-414-1325
Fax: 617-414-1331

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:

• Abbott
• Altana
• Alteon
• Alza
• Anika
• Asta Medica
• AstraZeneca
• Aventis
• Bayer
• Bertek
• Bristol Myers Squibb
• Celltech
• Chiron
• Eli Lilly
• Emisphere
• Endo
• Entropin
• Forest
• Genzyme
• GlaxoSmithKline
• Insmed
• Janssen
• Johnson & Johnson
• Merck
• Napp
• Neurocrine Biosciences
• NeurogesX
• Novartis
• ONO Pharma
• Pain Therapeutics
• Parke Davis
• Personal Product
• Pfizer
• Pharmacia/Searle
• Proctor & Gamble
• Progenics
• Purdue Pharma LP
• Roche
• R.W. Johnson
• Schwarz
• TAP
• United Therapeutics
• Wyeth-Ayerst
• Zycos

Multiple CRO’s have worked with Arizona Research Center . Among them are:

• Bailer Research
• B & B Clinical Investigators
• Clinimetrics
• Covance
• INC Research
• Ingenix/i3 Research
• Integrium
• Kendle
• Omnicare
• Paragon
• Parexel
• Pharmanet
• PPD
• PRA
• Rheumatology Research International
• Quintiles
• SCIREX

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
• Endocrinology
• Gastroenterology
• Immunology / Infectious Disease / HIV
• Musculoskeletal
• Nephrology / Urology
• Neurology
• Orthopedics
• Pain
• Psychiatry / Psychology
• Pulmonary / Respiratory Disease
• Rheumatology
• Trauma / Emergency Medicine

Staff Expertise

Regulatory Department
Arizona Research Center’s regulatory specialists process the start-up paperwork rapidly and work diligently to maintain all regulatory documents throughout the study.

Business Development
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.

Contact Information

Site Director
Arizona Research Center
2525 W. Greenway Rd., Suite 114
Phoenix, AZ 85023 USA
Phone: 602-863-6363
Fax: 602-863-6611
E-mail: [email protected]

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