“The world’s local central lab. Global reach. Local expertise.”

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LabConnect Overview• Global laboratory services

organization supporting studies across six continents

• Central laboratory services– Worldwide testing for clinical

studies– Project and data management– Supplies and logistics

• 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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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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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.

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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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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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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

Experience by Therapeutic Area

Cardiology9%

CNS11%

Dermatology16%

Endocrinology4%GI

4%Infectious Disease8%

Misc20%

Oncology23%

Women's Health6%

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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Central Lab Services

• Project Management• Investigator Site Support• Specimen Collection and

Transport Supplies• Logistics• Reporting-ClinReach™

o Fax/Email/VPN/Webo TAT-Day of receipt

• Data Management• Specimen Tracking and

Management• Worldwide Biostorage

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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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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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LabConnect Project Management Coordination of Full Spectrum of Laboratory

Services across Network

Specimen Tracking

Bioanalytical Testing

Esoteric Testing

Routine Testing

Full Coordination of

Data Management

Kits

Logistics

Training Materials

Sample Management

Ongoing Site Support

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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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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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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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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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Custom Collection/Transport Supplies

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Custom Collection/Transport Supplies

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Custom Collection/Transport Supplies

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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

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

Web-Based Reporting

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Trending Reports

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Trending Reports

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Trending Reports

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Trending Reports

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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

Data Management

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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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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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Sample Tracking and Management

• LabConnect offers comprehensive menu specimen management services.

• Tracking• Identification• Management• Storage

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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

There are gaps in current sample tracking systems

Sites Central lab

Lab 3

Lab 1

Lab 2Client or storage

Samples are not monitored until they are

received at a lab or by the client.

Labs (academia or specialized labs) frequently

do not have automated sample management

capabilities

Difficult to reconcile multiple outputs from

different locations. Increased error rate.

LabConnect sample tracking system

Sites LabConnect

Lab 3

Lab 1

Lab 2Client or storage

Digital pen technology and data integration tools allows instant access to sample information and comprehensive real time

sample tracking.

Database

Digital pen technology allows increased visibility without

changing behavior

Site personnel

Sample Collection

Site documentation

Sample stored, batched

shipped later

Sample shipped

1 2 3Lab receives

sample and enters into LIMS

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Digital pen captures site documentation instantly,

importing to database

Labs

Storage csv, excel, xml, ascii, txt

csv, excel, xml, ascii, txt

csv, excel, xml, ascii, txt

DB

Sites

• Canned queries• Reports

• Ask questions about the samples

• Filter• Search

Integration of various sample data files

Case study: Sample tracking solution for large pharma company

Sites

Lab5

Lab4

Lab3

Lab2

Lab1

Client lab

Client storage

Sample types:Tumor

Cell pelletSkinCTCHair

BloodSerum

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

LabConnect System Benefits

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• 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

www.labconnectllc.com

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