Abt Associates Inc. Abt Associates Clinical Trials Comprehensive clinical research services

Transcription

1 Abt Associates Inc. Abt Associates Clinical Trials Comprehensive clinical research services

2 Providing a wide range of clinical research services Abt Associates Clinical Trials (AACT) is dedicated to providing our clients with a full range of high-quality clinical research services all with unparalleled academic and scientific credibility. Our services include strategic planning, protocol development, clinical trials operations and medical affairs, data management, statistical design and analysis, patient registries, health economics and outcomes research, reporting, pricing strategy, and more. We provide these services to pharmaceutical, biotechnology, and medical device companies as well as government agencies and public health organizations. We work closely with our clients in most therapeutic areas to help achieve their critical clinical and marketing objectives. Each project leverages our experience, proven methodologies, clinical research expertise, and uncompromising commitment to objective research.

3 A Comprehensive Solution for Clinical Research In all key areas of clinical research, AACT brings you the in-house clinical and technical expertise, years of experience in diverse studies, and innovative thinking necessary for effective clinical research. Clinical Operations and Medical Affairs Our Clinical Operations and Medical Affairs group provides the full range of clinical trials management services for Phase I - IV clinical trials. These services include developing study protocols and support materials, selection and training of qualified investigators, clinical monitoring, interpretation of clinical trial results, evaluation and handling of adverse medical events, and medical writing. Our full-time staff includes project managers, physicians and regional CRAs with experience in key therapeutic areas. This group also provides project support in medical monitoring, serious adverse event management, medical consultation and scientific communications. Medical monitoring is available on-call, 24 hours a day. AACT Medical Monitors interface with both investigators and clients as needed to ensure adherence to project protocols and standards. Biostatistics and Epidemiology Our Biostatistics and Epidemiology Department is involved principally in three types of studies: clinical trials, epidemiological studies, and patient registries. For Phase I-IV clinical trials, the group provides study design, clinical data processing, statistical analysis, and reporting. For epidemiological studies, the group designs and conducts the study, performs the data processing, analyzes the data, and reports on the results. For patient registries, the group designs the registry, implements and administers it, performs the data processing, analyzes the data, and reports on the results. The full-time staff includes biostatisticians and epidemiologists (both Ph.D. and Master s level), statistical programmers, data managers, project managers, and study coordinators. We have experience working with a number of leading EDC vendors and continue to support paper-based and mixed methodology studies. Health Economic Research and Quality of Life Evaluation Services Our Health Economic Research and Quality of Life Evaluation Services group collects and analyzes data on healthcare utilization and evaluates the clinical, quality of life, patient satisfaction, and economic outcomes of that care in order to understand the market for products in development, demonstrate the value of services or products, and/or price new products. It has also developed innovative registries that use state-of-the-art, cost-effective data collection methodologies. Our staff includes full-time health economists, policy analysts, reimbursement specialists, and market researchers. We employ a variety of federal, state and HMO databases that provide retrospective information on healthcare utilization and costs, as well as assistance in designing prospective health economics studies. Registries and Epidemiological Studies In addition to clinical trials, we conduct patient registries and epidemiological studies. These studies are sometimes mandated by regulatory agencies for purposes of monitoring safety. They are often designed by our sponsors to develop generalizable data about real-world experience with the drug, biologic, and/or device in community practice. Regulatory Affairs Consulting Our Regulatory Affairs Consulting services include consultative interaction with clients on key regulatory issues and strategies, client representation at the FDA (and other countryspecific regulatory agencies), preparation and submission of regulatory documents, timely reporting of serious adverse medical events, and more. This powerful combination of services ensures that our public and private clients get the clinical research services they need all at the same high level of quality and responsiveness that has earned Abt Associates a reputation for excellence. In short, we go far beyond traditional contract research organizations in the breadth of our services and the depth of our experience. To find out more about AACT and Abt Associates, go to

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5 Exceptional Clinical Research At AACT, our staff provides all of the elements necessary for high-quality clinical research: Expertise Knowledge Client focus Years of industry experience Broad multi-disciplinary training Scientific and academic credibility Our comprehensive therapeutic experience includes: AIDS and AIDS-related disorders Anesthesiology Cardiovascular/cardiology Dermatology Ear/Nose/Mouth/Throat Endocrinology Gastroenterology Urology Hematology Immunology Infectious Diseases Lysosomal Storage Disorders Metabolism Nephrology Neurology Nutritionals Oncology Ophthalmology Orthopedics Pain Pulmonary/Respiratory Rheumatology Women s Health

6 Abt Associates Clinical Trials Abt Associates Inc. 55 Wheeler Street Cambridge, MA fax