1. “The world’s local central lab. Global
reach. Local expertise.”
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2. LabConnect Overview
• Global laboratory services
organization supporting studies
across six continents
• Central laboratory services
– Worldwide testing for clinical
studies
– Project and data management
QuickTime™ and a
decompressor
– Supplies and logistics
are needed to see this picture.
• Specialized laboratory services
– Leverage network to design
solutions to match client needs
– Focus on specialized analysis and
external R&D project management
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3. LabConnect Overview-
Experience
• Approximately 340
contracted studies
since company’s
inception in late 2002.
• 80-90 new projects
per year.
• Diverse client base
• Customized service
solutions
• Comprehensive
Laboratory Project
Management
• Client Service/Follow
Up/Flexibility
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4. Organizational Design
• Foundation Concepts- Business Model
– Service Orientation (Project
Management, Data Delivery, Site
Support)
– Geographic Reach
– Analytical Diversity
• LabConnect study support team
– Conduct all pre/post analytical
functions.
– Project management
– Data management
– Reporting
– Logistic and supply coordination
– Training and site support
• Worldwide network of laboratories
selected for their clinical research
experience, geographic locations and
analytical expertise. 4

5. Global Locations
Central Laboratory Locations-Primary
• North America-Johnson City, TN
• Europe-Gdansk, Poland
• Asia-Mumbai, India
• Asia-Guangzhou, China
Central Laboratory Locations-Regional
• Europe-Bucharest, Romania
• Europe-Kiev, Ukraine
• Europe-Minsk, Belarus
• Europe-Tbilisi, Georgia
• Asia-Seoul, South Korea
• Asia-Tel Aviv, Israel
• Asia-Istanbul, Turkey
• Africa- Cape Town, SA
• Australia-Melbourne
• Australia-Sydney
• South America-Buenos Aires
Specialized Laboratories (15 labs)
• Platform expertise
• Therapeutic area
• Analysis category
Corporate Offices
• Seattle, WA
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6. Analytical Capabilities
• Routine and Specialized Laboratory
Testing
• Molecular Diagnostics
• Oncology
• Flow Cytometry
• Molecular Oncology
• Immunohistochemistry
• Cytogenetics
• Circulating Tumor Cells
• Microbiology
• Multiplex Assay
• ELISA
• Analytical Chemistry
• Immunoassays
• Immunogenicity assays
• Method Development Services
• Anatomic Pathology
• Biostorage
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7. Network Standards and
Harmonization
• Participating Laboratories
all have region specific
accreditations including
CAP, CLIA, ISO 17025
• Proficiency testing
• Track record of
successful audits by
Sponsors and CRO’s
• Qualification Process
• Internal audits
• Intra-laboratory
comparison studies

8. Experience by Therapeutic
Area
Women's Health Cardiology
6% 9%
CNS
11%
Oncology
23%
Dermatology
16%
Misc Endocrinology
20% GI 4%
Infectious Disease 4%
8%

9. Competitive Advantages
• Custom service plans for each project
• Coordination of all laboratory requirements
– Routine
– Esoteric
– Biomarker
– Pharmacogenomic
– Pharmacokinetics
– Bio-storage
• Analytical expertise
– Selected for your project
– Available across the globe
• Innovative and flexible reporting technologies
• Service focused organization
• Regional expertise
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10. Central Lab Services
• Project Management
• Investigator Site Support
• Specimen Collection and
Transport Supplies
• Logistics
• Reporting-ClinReach™
o Fax/Email/VPN/Web
o TAT-Day of receipt
• Data Management
• Specimen Tracking and
Management
• Worldwide Biostorage
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11. Specialized Services Support
• Combines Scientific Project Management
expertise with LabConnect network and
infrastructure
• Broad base of analytical capabilities and
experience within network
• Assay Development
• Integration with LabConnect Project Management
and Project Support
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12. Project Management
• A Project Manager will be assigned to your study
• For global studies, regional project teams will
support each unique geographic region
• The Project Manager
– Establish the standards for study documents
– Coordinate activities across LabConnect
Network
– Provide ongoing support to your project
• Participate in project team meetings
• Monitor results and investigator site
compliance
• Ensure that deliverable dates are met.
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13. LabConnect Project Management
Coordination of Full Spectrum of Laboratory
Services across Network
Specimen Full Coordination of
Routine
Tracking
Testing Data Management
Kits
Logistics
Training Materials
Sample Management
Bioanalytical Esoteric
Testing Testing Ongoing Site Support
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14. Study Start Up
– Complete-”Statement of
Work” (SOW)
– Study set up
• Investigator Manual
• LIS/IT Validation
• Test Data Transfer
• Requisitions
• Kits to Sites
– On average, initial
shipments are delivered to
sites within four to six
weeks after SOW is
completed.
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15. Investigator Site Support
• Training
–Investigator Meetings
• Off Site
• Web-based
– Comprehensive
Laboratory Manual
• Telephonic and email
access to site support
• Employee compensation
is tied to investigator site
satisfaction
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16. Investigator Site Survey Results
(Cumulative through September 2010)
ACM Covance ICON LabConnect LabCorp Quest Quintiles Other
% % % % % % % %
Best Client Service Staff Total 3% 39% 10% 44% 5% 14% 14% 12%
Best Courier Service Total 3% 36% 11% 33% 6% 26% 16% 17%
Best Lab Kits Total 5% 41% 14% 39% 4% 13% 18% 18%
Best Lab Reports Total 4% 37% 10% 41% 7% 17% 16% 11%
Best Lab Requisition Forms Total 3% 40% 10% 38% 5% 16% 18% 4%
Best Study Training & Manuals Total 3% 39% 12% 36% 5% 17% 20% 12%
Best Overall Service Total 3% 37% 9% 41% 4% 16% 13% 10%
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17. Custom Collection/Transport Supplies
• Kits are custom designed by Project Management to
meet your specific requirements
• Each collection kit comes contained within the return
shipper.
• Tubes are pre-labeled to minimize errors
• Pre-printed shipping labels
• Kits are study/site/visit specific
• Resupply requests will be fulfilled within 3-5 business
days
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18. Custom Collection/Transport Supplies
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19. Custom Collection/Transport Supplies
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20. Custom Collection/Transport Supplies
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21. Reporting-LabREACH Technology
• Reports Include:
– Abnormal and Flag
Alerts
– Historical values for
out of range results
– Custom
calculations/reports
• Same Day Delivery
via LabREACH™:
– LabREACH™ Suite
• Direct
• Online
• AutoFax
• Email 21

22. Web-Based Reporting
Subject results are reported in tabular format with
several visits displayed at one time
Results are color coded for easy identification of
“out of range” or critical values 22

23. Trending Reports
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24. Trending Reports
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25. Trending Reports
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26. Trending Reports
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27. Data Management
The delivery of clean data throughout
your study is achieved through the
execution of basic processes.
• Requisition Slips
– Have easy to follow instructions
– Protocol/Site/Visit specific
– Bar-coded Accession Number
• Pre-labeled collection tubes
• Automated order entry system
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28. Data Management/Data
Delivery
• Real time resolution of specimen, requisition, and
demographic inconsistencies.
• Project Management and/or Investigator Services
will notify the site to resolve.
• Daily order entry QC reports and resolution
• Data can be transmitted according to your pre-
defined schedule, monthly transfer is standard.
• ASCII and CDISC data formats standard
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29. Specimen Logistics
Samples will be delivered from the
sites to the laboratory within 24-36
hours
FedEx and DHL are primary couriers
Dry ice can be provided to the sites
should they require.
Delivery times will be monitored and
corrective action taken as needed
If needed, dry runs will be conducted
to determine transport times and aid in
courier selection
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30. Sample Tracking and
Management
• LabConnect offers
comprehensive menu
specimen management
services.
• Tracking
• Identification
• Management
• Storage
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31. Current challenges in sample
tracking
• Increase in esoteric testing requires more
detailed sample management
• Difficult to get comprehensive sample
reconciliation during on-going clinical trial
– Sample tracking is often done manually by clinical
operations group, requires extra man hours and
results in higher error rate
• Limited visibility at sites
– Specimens can sit at sites for extended periods
– No visibility until samples are shipped/received at
a lab
– Difficult to catch problems at a resolvable stage
• Hard to monitor sample quality
• Difficult to identify samples in system based on
clinical criteria

32. There are gaps in current sample
tracking systems
Lab 1
Client or
Sites Central lab Lab 2
storage
Lab 3
Samples are not Labs (academia or Difficult to reconcile
monitored until they are specialized labs) frequently multiple outputs from
received at a lab or by the do not have automated different locations.
client. sample management Increased error rate.
capabilities

33. LabConnect sample tracking
system
Lab 1
Client or
Sites LabConnect Lab 2
storage
Lab 3
Database
Digital pen technology and data integration tools allows instant
access to sample information and comprehensive real time
sample tracking.

34. Digital pen technology allows
increased visibility without
changing behavior
1 2 3 4
Sample Lab receives
Sample sample and enters
Collection shipped
into LIMS
Site
documentation
Sample
stored,
Site personnel
batched
shipped later
Digital pen captures site
documentation instantly,
importing to database

35. Integration of various sample data
files
csv, excel,
Sites xml, ascii, txt
Labs csv, excel,
xml, ascii, txt DB
• Canned queries
csv, excel, • Reports
Storage
xml, ascii, txt • Ask questions about
the samples
• Filter
• Search

36. Case study: Sample tracking solution for large
pharma company
Lab1
Sample
types: Lab2
Tumor Sites Client lab
Cell pellet Lab3
Skin
CTC Lab4 Client storage
Hair
Blood Lab5
Serum
Plasma- 16
aliquots
 Samples being tracked manually, by multiple people
 Data was inconsistent, full of errors, not complete
 Samples were unaccounted for
 Difficult to determine number of missing samples

37. LabConnect System Benefits
• Real time tracking, starting at the time of collection
• Instant accessioning
• Better control on shipping logistics
• Fast identification and correction of queries/issues
• Multiple user web access (smart phone application
available)
• Customizable reports
• Solid chain of custody
• Yields documented quality sample management and
saves time
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38. www.labconnectllc.com
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