ARA | Contract Research Services

AIDS Research Alliance
Contract Research Services
—Your greatest ally in the HIV/AIDS drug development process—

Overview of Capabilities

For many of the large HIV/AIDS drug development companies, AIDS Research Alliance (ARA) is a leading clinical research site with a proven track record for extremely rapid patient enrollment (even for hard-to-reach groups such as treatment-naïve patients) and exceptional data collection.

As a not-for-profit organization, ARA contains study costs while ensuring the seamless implementation of clinical studies, and is uniquely positioned to meet the needs of HIV/AIDS drug development companies. Speeding up study implementation, enrollment and completion without compromising data integrity is an ARA hallmark.

For development-stage companies, ARA is a full-service contract research organization, or CRO, for companies engaged in HIV and AIDS-related drug development. These services have grown to include critical-path-to-market analysis, pre-clinical consulting and strategy, clinical protocol design and writing, case report form (CRF) design, regulatory affairs, data management, biostatistical design/analysis and study report writing.

Clinical Trials Expertise		Project Management and Support Services
Phase I-IV		Regulatory Affairs
First-in-Man Studies		Pre-Clinical Development
Pharmacokinetics		Study Design & Protocol Writing
Drug Interaction Studies		CRF Design and Development
In-Patient Studies		Data Management
Neurological Studies		Biostatistics
		AIDS Community Relations

• Enrollment: direct access to over 10,000 HIV+ individuals through affiliations with local primary care providers. ARA maintains an in-house patient database with over 2,000 well-characterized patients. Most trials conducted at ARA are enrolled entirely through this database alone. (Click here for more information about patient recruitment & retention.)

• ARA has established relationships with basic research laboratories and toxicology research groups for pre-clinical development work and/or specialized endpoint measurements for clinical studies.

• 8800 sq. ft. state-of-the-art clinical research facility which includes 3 fully-equipped exam rooms, in-house NASBA viral load testing and sample archiving in -20°C and -70°C freezers.

For more information about working with ARA either as a clinical study site or for drug-development consulting and CRO services, please contact:

Stephen J. Brown, MD
Director of Clinical Research

Dr. Brown has been AIDS Research Alliance's (ARA) Director of Clinical Research since 1997. Dr. Brown attended Hahnemann University Medical School and performed his internship there as well. Prior to coming to ARA, he was Study Manager at the HIV Neurobehavioral Research Center (HNRC) at the University of California, San Diego (UCSD) and managed studies on HIV-associated cognitive impairment including the NIMH study of Peptide T and a study for Glaxo Wellcome. Additionally, Dr. Brown received an HIV Neurobehavioral Research Fellowship, was an Assistant Clinical Professor at the UCSD School of Medicine, Department of Psychiatry and was a member of UCSD's Institutional Review Board. During his tenure at ARA, Dr. Brown has been the Principal Investigator on more than 16 clinical trials. He is a member of the American Academy of Pharmaceutical Physicians, the Drug Information Association and the Society for Clinical Trials and is Board Certified in Psychiatry and Forensic Psychiatry. Dr. Brown oversees all clinical and scientific activities at ARA.

George C. Fareed, MD
Medical Director

Dr. Fareed has been ARA's Medical Director since 1995. Dr. Fareed attended Harvard Medical School and performed his internship at Peter Bent Brigham Hospital. Dr. Fareed was an Assistant Professor at Harvard Medical School and has been an Adjunct Associate Professor at UCLA School of Medicine since 1983. Dr. Fareed was the founder of International Genetic Engineering, Inc. (INGENE) which later merged with Xoma Corp. In addition to being ARA's Medical Director, Dr. Fareed is also the Director of the Special Infection (HIV) Clinic in the Clinica de Salud del Pueblo and is a member of ARA's Medical Executive Committee (MEC). Dr. Fareed serves as a Principal Investigator and participates in clinical development and scientific strategic planning.

Michele Vertucci, PA-C
Clinical Trials Coordinator/Manager

Michele Vertucci, PA-C, has been ARA's Clinical Trials Coordinator/Manager since 2004. Michele received her Associate Degree in Nursing from American River College and is a Certified Clinical Trials Coordinator. Prior to coming to ARA, Sergio was the Clinical Research Nurse Manager at LAC+USC Medical Center, Division of Infectious Diseases—AIDS Clinical Trials Group where he supervised 12 Study Coordinators. He has been the study coordinator for over 24 HIV/AIDS clinical trials. Sergio supervises the Study Coordinators and the Clinical Research support staff.

Peter A. Anton, MD
University of California, Los Angeles
Member, ARA Medical Executive Committee

Dr. Anton is a member of ARA's Medical Executive Committee and has collaborated with ARA on several scientific projects. He received his medical degree from Case Western Reserve University School of Medicine and interned at Brigham and Women's Hospital, Harvard Medical School. Dr. Anton is currently the Associate Director of the UCLA Inflammatory Bowel Disease Clinical and Research Center and the Director of the UCLA Center for HIV and Digestive Diseases. ARA is working with Dr. Anton on a study of mucosal changes in viral load in gut associated lymphoid tissue.

Patient Recruitment & Retention

Slow patient accrual is the leading reason for delays in the clinical development of experimental drugs. Because our mission is to help get promising new treatments to HIV-infected people as quickly as possible, we are committed to not allowing slow patient accrual delay the clinical development of your compound.

• Very large in-house database of patients specifically interested in participating in clinical drug trials of experimental HIV/AIDS drugs or preventative vaccines.

• Visibility and positive reputation within the HIV community which eliminates many traditional barriers such as fear of the unknown inherent with many clinical study sites.

• Dedicated patient-recruitment staff who continually build and reinforce personal relationships with numerous community-based referral sources such as HIV testing centers, private physicians, community clinics and HIV social service providers.

• Culturally sensitive and appropriate advertising (when studies do not fully enroll from in-house database).

ARA maintains its own IRB which meets all requirements of Title 21 Part 56 of the U.S. Code of Federal Regulations. The IRB at ARA maintains a regular, monthly meeting schedule, but is willing to meet more frequently, as needed for rapid study review. In 1999, the ARA IRB received a routine FDA audit which resulted in a "no findings" outcome. All ARA IRB procedures and documents was deemed to be in full compliance with all applicable regulations for all studies review during the previous 3 years. (Click here for more information about the ARA IRB.)

Would you like to donate to AIDS Research Alliance and be a part of the team that funds important HIV/AIDS research? Click below to go to our donation page.