LabConnect provides global centralized bioanalytical, safety, genotyping and biostorage laboratory services for the biopharmaceutical industry. LabConnect is committed to delivering high quality central laboratory services by providing specialized customer service, innovative data management and reporting systems, and competitive pricing structures.

Unlike any other provider operating in the central laboratory industry today, LabConnect dedicates nearly 100% of our capital and human resources to the most critical functions provided by a central laboratory—project management, customer service, data management, reporting and logistics. LabConnect’s exclusive focus on central laboratory services for clinical trials translates to professional and responsive client service, innovative reporting tools, and superior pricing.

Benefits of working with LabConnect include:

• High-quality, accredited (CLIA, CAP and State) laboratory with 20-year reputation for excellence
• Esoteric test method development and validation including high complexity molecular and analytical chemistry
• In-house kit services
• Long-term storage of biomaterial samples
• Professional and highly responsive customer service and project management personnel
• Site support that is second to none
• Laboratory data management services and systems specifically created to ensure the delivery of “clean” data while allowing flexibility in database design
• LabReport ™, a unique package of reporting options that includes a web-based reporting platform and other report delivery modalities that provide easy and immediate access to patient results in a secure, HIPAA-compliant environment
• Rapid proposal turnaround and price structures that may reduce your laboratory costs by more than 20%

LabConnect is proud of its affiliation with Mountain States Health Alliance (MSHA), a highly regarded, superior quality reference laboratory. MiSHA has more than 20 years experience in providing both hospital-based and reference laboratory services. MiSHA laboratory maintains all appropriate accreditations including CLIA, State and CAP. Through this affiliation, LabConnect is able to provide a wide array of testing services including:

Biochemical Genetics Coagulation Cytogenics Diabetes Testing Histopathology Immunochemistry Infectious Disease Metabolism Molecular Genetics Molecular Microbiology Molecular Oncology

Mycobacteriology Mycology Oncology/Tumor Markers Parathyroid Polypeptides Serology Steroids Thyroid Toxicology Virology

LabConnect’s esoteric lab, CLS, has more than a decade of experience in esoteric test method development and validation including high complexity molecular and analytical chemistry. The services offered include preclinical vaccine, infectious disease, drug, and biological assay development capabilities. A forerunner in the latest technological advances in infectious disease and vaccine research, CLS boasts a complete menu of assays for all FDA-approved HIV antiretroviral drugs. Our CLS facility is a GLP/GCP compliant, fully-equipped laboratory able to support clinical trials of varying complexity and size. Capabilities include:

General

• Expansive Hepatitis and HIV Panels
• Broad Oncology Testing Menu
• Hormone & Allergy Testing
• Testing on multiple specimen types, including CSF

Research and Development

• PBMC Processing – Ficoll & Accuspin Methods
• Cell Counting – Manual & Automated
• ELISpot Assays
• Intracellular Cytokine Staining (FCM)
• Immune Response Testing

Analytical Chemistry

• Complete Menu of Assays for all FDA-approved HIV antiretroviral drugs
• Intra-Cellular Drug Studies
• Pharmacokinetic Studies
• State of the Art Instrumentation for Drug Development Studies

Molecular Diagnostics

• HIV Genotyping Services (RT & Pro, T-20)
• Viral Subtyping for HBV & HVC
• HBV Drug Resistance Testing
• DNA Sequencing Capabilities
• Viral Load Testing for HIV, HCV & HBV using RT-PCR and branch DNA techniques
• Real-Time PCR

Biomaterial Sample Storage

• Aliquot Specific Tracking
• -70 ° C Harris UltraLow Freezers and -170° C Liquid Nitrogen Freezers
• 24 Hour Computerized Temperature Monitoring

Each trial is supported by a LabConnect Project Coordinator and Customer Service Specialists dedicated to the efficient and customer-friendly service. Our project teams’ compensation is directly tied to the results of our client satisfaction surveys. LabConnect’s Project Coordinators serve as the primary interface between the sponsor, the CRO and the laboratory. Project Coordinators are responsible for defining the scope of work outlined within the protocol and ensuring the seamless implementation of laboratory services into the overall project. The Project Coordinator will oversee the development of:

• investigator training materials;
• customized reporting;
• customized requisitions; and
• visit specific kits according to your specifications.

In addition, your project will be supported by our team of Customer Service Specialists. We believe in maintaining the highest standards in customer service and staff this important function with experienced healthcare professionals. Customer Service Specialists:

• handle investigators questions, concerns and re-supply requests;
• notify investigators and other designated personnel of alert and panic values as specified within the protocol; and
• maintain proactive contact with the investigator sites and track inventory levels according to usage with a maximum re-supply turnaround time of three business days.

LabConnect offers an innovative package of reporting options for individual patient results. Results are posted and delivered on the day the testing is completed. LabReport™ is our secure, HIPAA-compliant, proprietary lab reporting technology. LabReport™ provides you with secure access to patient results in real-time. On-line reports are available for all testing performed and include the most recent results as well as historical values. Abnormal and alert values are color-coded for easy reference.

Our easy-to-read reports are supported by the following products superior to any other central lab offering in the marketplace today:

• LabReport™; allows investigative sites to receive PDFs of daily lab reports automatically dropped into a designated hard-drive folder on their computer. Sites will receive an e-mail notification that they have received a new lab report and they may then elect to view and/or print these reports at a convenient time.
• LabReport™ delivers sites clean PDFs of subject results printable automatically or on-demand to a designated printer. AutoPrint is similar to traditional fax methods, yet there is no need for mailing of hard copies as the reports are ready to be placed within the CRF in the format received.
• LabReport™ provides traditional fax-based reporting with hard copies mailed via regular mail each day.
• LabReport™ provides sites and sponsors with a secure website to view lab data. Of particular note, users may view up to seven visits to look for trending data.

Accurate and timely data begins with detailed and proven processes. At LabConnect, we have combined these processes with a state-of-the-art data management platform so that we can deliver clean data according to your exacting specifications. Benefits include:

• protocol-specific, visit-specific, requisitions that include simple instructions for use by the investigator staff;
• bar-coded requisitions with a unique accession number and collection tubes pre-bar-code labeled to minimize errors and confusion;
• immediate matching of requisitions and samples to identify and resolve inconsistencies through coordination between our Customer Service Specialists and the investigator site;
• secure, redundant, data maintenance at our world-class data center ensuring business continuation and ongoing access to your data;
• customization of your database and ASCII formatted reports; and
• ability to transfer the data on your request, either on an incremental or cumulative basis through dial-up, diskette or e-mail Zip file methodologies.

LabConnect is dedicated to delivering quality central laboratory services at competitive prices. By affiliating with a highly regarded reference laboratory and establishing strategic partnerships with contract research organizations, we are able to develop leading edge products and services while maintaining a cost structure that enables us to pass significant savings on to the sponsors of clinical trials. Typical savings average 20-30% or more depending upon the parameters of your protocol.

We look forward to being at your service!

Contact Information

LabConnect, LLC
Jeff Mayhew, Chief Operating Officer
2832 East Arthur Place, Suite 200
Seattle, WA 98112 USA
Phone: 206-322-9149
Fax: 206-322-4682
E-mail:

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