Clinical Trials

Laboratories Northwest is a nationally accredited, full service laboratory organization providing services to the medical communities of western Washington. We provide professionally-directed diagnostic testing services for research activities within clinical trial facilities, hospitals, clinics and businesses. We offer the convenience of local service with an extensive array of routine and esoteric testing.

We have offered professional, responsive services to Phase I-IV Clinical Research clients since 1995. At the heart of our service is our commitment to full-service management of your laboratory data. Our validated systems can be individualized to meet the unique needs of each study. The Sunquest Laboratory Information System (LIS) is electronically interfaced with our testing equipment for accurate data transmission. Data is then extracted from the LIS and provided to sponsors according to their specific Electronic Data Specifications. Our validated systems provide for accuracy, speed, flexibility and quality in the data that we generate.

Laboratories Northwest delivers rapid response reference lab services and testing combined with information management to support clinical research in phases I-IV, including screening, safety and PD markers.

Laboratory Highlights:

• 25,000 sq. foot laboratory
• 3 million tests performed annually
• On-site Medical Director
• 7 Pathologists, specialty-certified
• 24/7 testing, stat and routine
• 258 laboratory professionals
• 99% of testing performed in-house
• Stat testing at no charge
• Protocol specific profiles available
• Customized, protocol specific, test request forms
• Secure Remote report printing
• Professional technical support and consultation
• Active 21CFR11 task force
• LIS system with complete audit trail

Additional highlights:

• Electronic Data Transfer capabilities
• Computer system validation reviews
• QA action systems implementation
• Quality systems review, development, training and implementation
• CRO specified sample retention
• Computer monitored specimen storage
• Business ethics employee guidance
• Microsample testing
• Recheck determinations at no charge
• LNW-directed specimen delivery system
• Active Continuing Education Program
• Personal Account Representative assigned to your study
• Panic alert notification by telephone
• HIPAA compliant
• Adult and Pediatric Reference Ranges

Quality Assurance

Registered with FDA, inspected by FDA for blood products
Validated methodologies
Rigorously maintained Quality Assurance Procedures
Compliance with GCP, GLP, GMO, CAP guidelines
21CFR11 compliant 3-level internal QA of study data

Proficiency Testing

• CAP
• CDC