Business Services Industry
Abt Associates launches new Contract Research Organization Division
Business Wire, June 19, 1997
CAMBRIDGE, Mass.--(BW HealthWire)--June 19, 1997--
International research and analysis firm announces new division dedicated to research services for the pharmaceutical, biotech and
medical device industries
Abt Associates Inc. announces today the launch of Abt Associates Clinical Trials (AACT), a new contract research organization (CRO) designed to guide pharmaceutical, biotechnology and medical device industry clients through the complex clinical development process and to assist them in bringing their products to market.
Based in Cambridge, AACT's research services include clinical trials management, biostatistics, epidemiology, pharmacoeconomics and outcomes research, regulatory affairs consulting, and market strategy.
Spanning more than 30 years of international government and corporate work, Abt Associates' experience in these services is extensive. The firm manages all domestic clinical trials of AIDS vaccine candidates sponsored by the National Institute of Allergy and Infectious Diseases. The company has also worked extensively for the Centers for Disease Control and the National Cancer Institute, as well as top managed care organizations to develop their marketing strategies and member satisfaction programs.
"Over the next two years, we expect AACT to be the fastest growing division of Abt Associates," said Wendell Knox, president and CEO of Abt Associates. "The cornerstones of our company -- information gathering, analysis and knowledge -- have uniquely positioned this division to provide these types of services."
With the company's access to major health care data bases covering Medicare/Medicaid, hospitals and homecare, AACT's competitive advantage among top clinical research organizations is its ability to forecast current and future markets for its clients new biologics, drugs and devices.
Steven Fosburg, division vice president, heads up AACT with Janice Maran, Ph.D., as executive director of business development and Gene Poggio, Ph.D., managing vice president, directing biostatistics and epidemiology. Robert Saldana, Pharm.D., is executive director of clinical operations and Chris Pashos, Ph.D., is director of pharmacoeconomics and outcomes research.
Highlights of AACT's services:
-- Clinical Operations: This unit provides the full range of clinical trials management services for Phase II - IV clinical trials. These services include developing study protocols and support materials, selection of qualified investigators, monitoring of investigative sites by experienced and clinical research associates, interpretation of clinical trial results, evaluation and handling of adverse medical events, and medical writing.
-- Biostatistics and Epidemiology: Study design, clinical data processing, statistical analysis and reporting for Phase I-III clinical trials and for Phase I-IIIb (periapproval) and Phase IV (post-marketing) investigations including epidemiology studies.
-- Pharmacoeconomics and Outcomes Research: Gathering and analyzing data on health care utilization, this unit evaluates the clinical, quality of life and economic outcomes of that care to illustrate the value of specific products and services.
-- Databases: The backbone of Abt Associates' work, data management and processing, is at the heart of this capability. Federal, state and HMO databases can provide valuable retrospective information on health care utilization and costs. These databases are also extremely useful in designing prospective health economic studies.
-- Regulatory Affairs Consulting: These services include consultative interaction with clients and ethical committees on regulatory issues and strategies, client representation at the FDA, preparation and submission of regulatory documents, timely reporting of serious adverse events and Good Clinical Practices consulting.
Founded in 1965 to solve important problems in society through research and analysis, Abt Associates provides governmental and business clients with social, demographic, economic and policy research, as well as business research and consulting spanning areas and industries from welfare reform to food production to technology. The employee-owned firm has offices in Cambridge and Amherst, Massachusetts; Bethesda, Maryland; Chicago, Illinois; Moscow, Russia, and Johannesburg, South Africa. The company's annual revenue exceeds $100 million.
CONTACT: Mullen PR
Brent Jones
508/468-1155 x.124
or
Abt Associates Clinical Trials (ACCT)
Janice W. Maran, Ph.D.
617/520-3049
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