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Support Services

WIL Research Quality Assurance Program

Quality is inherent in all operations at WIL Research. Our comprehensive standard operating procedures, initial GLP training for new hires and yearly GLP refresher training as well as the comprehensive technical training by experienced staff members ensures that all operations at WIL provide quality data collection and reporting.

The Quality Assurance Unit consists of experienced and well-trained auditors with many years of experience in toxicology operations, auditing, and a solid understanding of Good Laboratory Practices (GLP). Many have RQAP-GLP Certification. The Unit monitors and audits study progress from study initiation to final report.

The Quality Assurance Unit (QAU) reviews all protocols and amendments, attends pre-study meetings, conducts in-process inspections for all regulated studies, conducts yearly facility inspections, reviews the raw data and final reports to ensure that all of the protocol objectives are achieved and that the data are representative of the quality expected by WIL Research Management.

The frequent interaction between the compliance specialist, study directors, technical staff and management provide a strong foundation to maintain the continued high level of accuracy and quality in the studies conducted by WIL Research.

Information Systems

WIL Toxicology Data Management System (WTDMS™) is a protocol-driven software system that was the first in the CRO industry and became the prototype for other major toxicology testing laboratories. Among its benefits are:

• Protocol-driven modular design
• Integrates all phases of the study
• Statistical capabilities
• Complete audit trail recording
• Validated system
• Secure system that requires both a login password and a program access password. Authority checks for program use are controlled by assignment of security levels to each user
• Experienced IS support staff

Study Analysis & Reports

The Study Analysis and Reports staff is a centralized department consisting of degreed individuals specifically trained and experienced in toxicological reporting and electronic publications.

• Reports are formatted according to regulatory guidelines (FDA, EPA, EEC, OECD, ICH, MAFF and MHLW).
• Custom formatting available
• All reports are generated electronically (PDF) at all draft stages (Unaudited draft, audited draft, etc)
• Writers collaborate with all areas of the organization in preparing reports
• Interact with all technical areas to ensure that each report accurately reflects the study
• Interact with study directors and pathologists to ensure interpretation of the data is accurately represented
• Reports completed in a timely fashion

Validation

WIL Research has developed a centralized validation team and strategy to ensure that new systems, whether commercial or developed internally, are functioning appropriately and meet regulatory, quality, and business requirements.