Westat, founded in 1961, is an employee-owned research firm known for the quality of its statistical design, study management, data collection, data management and analysis. Westat’s headquarters is located in the Washington, DC, area, in close proximity to the Food and Drug Administration and the National Institutes of Health. For more than 40 years, Westat has provided research support for health studies to a wide variety of corporate and government clients. Our acquisition of Applied Logic Associates (ALA), a Houston, Texas-based full-service contract research firm, provides Westat with expertise in a wide range of therapeutic areas and expands our professional staff to better meet our client needs.

Areas of research include Phase I to IV clinical trials, epidemiologic research, and health statistics surveys. Our technical staff includes clinical project directors, nursing specialists, biomedical scientists, biostatisticians, epidemiologists, regulatory affairs specialists, clinical and laboratory monitors, medical technologists, economists, market analysts, computer systems analysts, and analytic programmers, in addition to our established network of clinical collaborators and physician consultants. Westat designs and conducts research projects of all sizes, customizing services to begin anywhere in a product’s development lifecycle and to provide a range of services appropriate to the client’s needs.

Preliminary Product Assessment

• Planning/Execution of Bioequivalence Trials
• Evaluation of Pharmacokinetics/Pharmacodynamics

Clinical Trial Management

• Site Identification, Qualification and Selection
• Protocol and Informed Consent Development
• Case Report Form Development
• Organization of Investigator Meetings
• Site Training
• GCP and GLP Auditing
• Clinical Site Monitoring
• Pharmacy Auditing
• QA/QC Oversight
• Preparation of Interim and Final Study Reports

Regulatory and Safety

• IRB/Ethics Committee Submissions
• DSMB Establishment, Management and Reporting
• Preparation of Regulatory Agency Filings
• Adverse Event Monitoring and Filings
• SAE Database Management
• Package Insert Preparation
• Preparation and Maintenance of Drug/Biologic Master File

Data Collection and Management

• Oracle Clinical™ Database Design and Validation
• Data Management, Audit and Documentation
• Data Collection - Electronic (Web and Batch Data Load), Paper and Telephone Interviews
• Medical Coding by MedDRA, COSTART and WHO-DD
• Query/Data Discrepancy Resolution
• Database QA and QC

Clinical Logistics and Tracking

• Customization of WesTrax™, Westat’s Interactive Voice Recognition System
• Patient Enrollment/Randomization
• Clinical Supply Management
• Management of Clinical Specimen Shipments
• Maintenance of Specimen Repository
• Storage and Distribution of Investigational Drugs
• Management and Tracking of Invoices and Payments
• Management and Tracking of Patient Reimbursements

Biostatistics

• Clinical Trial Design
• Statistical Programming and Validation
• Preparation of Statistical Reports and Summaries
• Interim Analyses
• Preparation of Safety and Efficacy Summaries
• DSMB Support

• Safety Surveillance
• Drug Effectiveness
• Patient-Reported Outcomes
• Quality of Life
• Outcomes Research
• Cost-Effectiveness
• Pharmacoepidemiology
• Drug/Disease Registries

Westat offers global support for clinical development through collaborations with international service organizations, which are chosen following extensive research into their capabilities, experience and reputation. Westat project managers coordinate clinical trial implementation through communication with the international teams. These collaborations provide a centralized point of contact throughout the study, in-country expertise in regulatory requirements and local clinical site monitoring capabilities.

Epidemiologic studies are becoming an increasingly important component in reducing clinical product development costs and time-to-market by identifying specific patient populations for targeted trials. Since 1978 Westat has provided epidemiological research support to the NCI’s Division of Cancer Epidemiology, other Federal health agencies, private industry clients, and for a significant number of large, long-term national and international epidemiologic studies. Study participation ranges from less than 100 to more than 150,000 participants, and study duration includes case-control studies conducted in less than 6 months, as well as cohort studies with participant follow-up for over 20 years.

For more than 40 years Westat has supported health research in many areas including disease, disability, nutrition and health education. Westat’s research services include project strategy, design, development and implementation, data collection and management, data analysis and final report development. Westat has conducted numerous studies requiring specifically trained medical and interview field staff to gather data on-site, in communities throughout the world. Data may be gathered from physical examinations of participants, by conducting in-person interviews, and/or through telephone, computer-assisted personal interviewing (CAPI) and audio computer-assisted self-interviewing (ACASI) capabilities. Our computerized interviewer file shows the availability, experience and performance of 5,000 interviewers throughout the United States, enabling us to staff new projects quickly and efficiently. A network of regional field supervisors directs the work of our experienced interviewers.

Westat maintains research offices in Rockville, Maryland; Durham, North Carolina; Atlanta, Georgia; and Houston, Texas.

Headquarters
Westat
1650 Research Boulevard
Rockville, MD 20850-3195

Westat’s customers are domestic and international pharmaceutical and biotechnology firms, as well as Federal health agencies.

Contact Information

Westat
Clinical Trials Coordinator
1650 Research Blvd., WB414
Rockville, MD 20878 USA
Phone: 301-294-4402
E-mail:

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