Industry Provider Profiles Company Type Services
Westat, founded in 1963, is an employee-owned corporation 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 50 years, Westat has provided research support for health studies to a wide variety of corporate and government clients.
Areas of research include Phase 1 to 4 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.
Trial Design and Protocol Development
Protocol development
Protocol amendments
Investigator brochures
Manual of Operations
Guidelines for collecting source documentation
Informed consent documents
Ancillary or related study documents
Regulatory and Safety
Standing in-house institutional review board (IRB)
Data monitoring committee (DMC) services’ support
Safety database management
Investigator brochure preparation
Food and Drug Administration (FDA) reports and filings preparation
Investigational new drug (IND) applications
IND amendments
IND annual reports
IND safety reports
Regulatory review of protocols and informed consent forms
Preparation of template informed consent forms
Management of site establishment and protocol registration processes
Preparation and maintenance of Clinical Trial Master File in accordance with the Federal requirements and ICH Guidelines. Paper and electronic file maintenance with a full internal quality assurance audit prior to delivery
Electronic data archiving services through a proprietary archive tracking system
Site Management
Identifying, qualifying, and selecting sites
Negotiating site contracts and budgets
Managing site payments
Supporting sites in local or central IRB/IEC submissions
Organizing and conducting investigator meetings
Designing/producing training materials and tools to support study execution (procedures manuals, regulatory and pharmacy binders)
Conducting site training
Establishing/maintaining toll-free help lines with 24/7 access
Tracking/documenting project communications for Trial Master File compliance
Providing sites with regular study updates (newsletters)
Coordinating/tracking custom materials (study drug, specialized lab kits, case report form binders and supplemental forms) and shipment of lab specimens
Site Monitoring
Conducting site assessment visits
Conducting clinical site monitoring visits (qualification, initiation, interim, pharmacy, and closeout)
Conducting Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) audits
Perform process and for-cause audits
Monitoring analytical laboratories
Data Management
Case report form (CRF) development through FrameMaker® application (other design tools also available upon request)
Clinical trial database design and validation through Oracle Clinical™ or Medidata® Rave application
Computerized patient eligibility screening and randomization
Data collection (electronic [web and batch data load], paper, and computer-assisted telephone interviews)
Extensive training program for Oracle Clinical’s™ web-based, electronic data capture (EDC) application
Medical coding using MedDRA, WHO-DD, plus any study-specific dictionaries
Data cleaning using programmed edit checks and manual reviews
Data reconciliation between different data collection systems
Electronic tracking and storage of CRFs and other data submissions
Data management reports
Data Monitoring Committees
Develop the DMC charter
Identify and recruit DMC members
Provide administrative support
Provide DMC meeting attendance and statistical support
Prepare and distribute DMC reports
Coordinate DMC communications
Manage and track member payments
Training Topics
Protocol related (protocol specific, Manual of Operations)
Good Clinical Practice (GCP)
Data management
Oracle Clinical™ Remote Data Capture (RDC)
WesTrax® IVR/IWR Technology
Participant enrollment and randomization
Clinical drug supply management
Participant unmasking capabilities
Management of clinical specimen shipments
Study site administration
Participant diaries or surveys using inbound or outbound interactive voice response (IVR) technology
Management of clinical and nonclinical supplies
Real-time Web reports
Ability to support global studies
Built-in practice center
Biostatistical Design and Analysis
Clinical trial design
Superiority trials
Non-inferiority trials
Parallel, factorial, cross-over
Fixed and adaptive/dynamic randomization schemes
Preparation of protocol statistical considerations section
Development of statistical analysis plan
Statistical programming and validation using SAS and other statistical software packages
Application of a broad range of statistical methodologies in preparation of statistical reports and summaries:
Longitudinal and repeated measures multivariable analysis
Modeling for age-dependent data and other potential confounders
Surrogate marker analysis
Time-to-event analysis
Bayesian statistical methods
Continual reassessment method for dose ranging/dose escalation studies
Adaptive clinical trial design
Interim and final statistical analyses
Production of statistical section of final clinical study report
Preparation of abstracts and presentations at scientific conferences
Preparation of manuscripts for peer-reviewed journals
Preparation of safety and efficacy summaries
Data monitoring committee (DMC) support (statistical/administrative support)
Support for preparing:
New Drug Applications (NDAs)
Biologics License Applications (BLAs)
Product License Applications (PLAs)
Annual Investigational New Drug (IND) safety updates
Meta-analyses
Statistical consulting
Phase 3b
Phase 4
Registries (drug, disease)
Patient-reported outcomes (PROs) and quality of life
Outcomes research
Patient satisfaction
Safety surveillance
Comparative effectiveness research (patient-centered outcomes research)
Cost-effectiveness
Pharmacoepidemiology
Other Health and Medical Area Experience
Epidemiology, surveillance, and intervention research
Health survey research
Health information technology
Health services and outcomes research
Health disparities
Health economics
Physical examination and health status surveys
Patient safety and satisfaction
Environmental exposure
Disability and long-term care
Veterans health
Mental health
Behavioral health
Westat offers global support for clinical trial development through collaboration with international service organizations, which are chosen following extensive research into their capabilities, experience and reputation. Westat project managers coordinate international teams to provide global services for clinical trials. These collaborations provide a centralized point of contact throughout the trial, as well as local expertise in regulatory requirements and on-site clinical monitoring capabilities. Our international services include:
Design and Development of Clinical Trials
Study design
Protocol development
Site Identification, Qualification, and Management
Site capability and readiness assessments (clinic, pharmacy, laboratory)
Site establishment and operations assistance (staffing requirements, study start-up, regulatory support, standard operating procedures development)
Site subcontracting, performance monitoring, and payment
Training
Training and technical guidance of site personnel (Good Clinical Practice [GCP], Good Laboratory Practice [GLP])
Protocol-specific training of research team members
Training on data entry systems and data management processes
Site and Laboratory Management and Monitoring
Ongoing protocol execution support
Clinical trials site monitoring
Laboratory monitoring
Performance oversight and compliance support
Data Management
Assessment of data management capabilities and systems
Technical advice on improving data management processes and systems
Data management capability building, standardization, and harmonization
Data management plans and data collection/processing guidelines development
Data collection form design, printing, and distribution
Database design and validation
Data receipt (hard-copy or electronic forms), logging, and tracking
Data entry (single or double data entry)
Training and other support for electronic data capture
Electronic data loading from laboratories and external sources
Data review, cleaning, and reconciliation
Medical coding
Study monitoring reports
Data delivery
Compliance
Guidance in support of compliance with U.S. and in-country human subjects protections regulations (ethics board reviews, informed consent)
Data monitoring committee (DMC) establishment, management, and reporting
Investigational New Drug (IND) application preparation and submission
Adverse event monitoring and filings
Serious adverse event (SAE) database development and management
Quality
Quality assurance (QA) procedures development and monitoring
Clinical site auditing
Statistical Analysis
Statistical analysis plans development
Statistical programming and validation
Statistical analysis
Statistical support for development of posters, presentations, and manuscripts
Laboratory Support
Laboratory assessments and evaluations
Assistance with compliance deficiencies and corrective actions
Review and monitoring of internal and external QA programs
Training in Good Laboratory Practice (GLP), Good Clinical Practice (GCP), blood-borne pathogens, and laboratory biosafety
Routine laboratory monitoring services (GLP, GCLP)
Mock inspections in preparation for laboratory accreditation and/or regulatory agency inspections/audits
Support for developing quality control procedures, quality assurance programs, and standard operating procedures
Support for site-specific specimen processing, transport, and storage guidelines
Training and implementing IATA guidelines
Records and data management
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 1976, 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 more than 20 years.
For more than 50 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's staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC. Westat also maintains research offices near our clients in Atlanta, Georgia; Cambridge, Massachusetts; Durham, North Carolina; Philadelphia, Pennsylvania; and Houston, Texas. In addition, we have international offices in Beijing, China; Liberia, Costa Rica; Addis Ababa, Ethiopia; New Delhi, India; Johannesburg, South Africa; and Bangkok, Thailand. Additional staff members are engaged in data collection and processing at Westat's survey processing facilities, at our Telephone Research Center facilities, and throughout our nationwide field interviewing operations.
Headquarters
Westat
Westat’s customers are domestic and international pharmaceutical and biotechnology firms, as well as Federal health agencies.
Clinical Trials Coordinatorwww.westat.com/Clinical_Trials// View Map Contact Company
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