LabConnect is a global laboratory services company that provides centralized laboratory services, scientific operations support, and project management for clinical trials. They offer services such as data management, customized collection kits, global logistics planning, training, and project management from pre-clinical through phase IV trials. They have a global network of partner laboratories that provide regional expertise, accreditations, and harmonized testing. Their services also include sample tracking, data management software, biostorage, and client satisfaction is high according to surveys.

1. Jeff Mayhew, Chief Development Director

2. ©2012, LabConnect LLC. All rights reserved.
Introduction
Central Laboratory Services
• Data management and reporting
• Custom collection kits & supplies
• Global logistics planning
• Training and site support
• Project management – pre-clinical & phase I-IV
Scientific Operations Support
• Outsourcing scientific and technical support
• R&D project management
• Test site coordination
• Specialized data analysis
• Early development services
Global Laboratory Services, Project Management and
Data Management Organization
Seattle, WA

3. ©2012, LabConnect LLC. All rights reserved.
Introduction
Menu of Services
Project
Management
Scientific
Operations
Global Lab
Network
Data Management Specimen
Collection Kits
Sample
Management
BioStorage

4. ©2012, LabConnect LLC. All rights reserved.
Global Network of Laboratories
We are the Global Network of Labs that Fits Your Needs
Network Partners &
Regional Experts
• Experience &
in-house testing
• Region-specific
accreditations
• Lab harmonization
• Audited internal &
externally for quality
and consistency
Therapeutics &
Analytical Experts
• Oncology
• Genomics
• Virology
• Flow cytometry
• Biomarkers
• Molecular diagnostics
• Coagulation

5. ©2012, LabConnect LLC. All rights reserved.
Global Networks of Laboratories

6. ©2012, LabConnect LLC. All rights reserved.
Project Management
Duties and Responsibilities
Full Coordination and Accountability
Laboratory
Testing
Investigator
Support
Sample
Management
Logistics &
Tracking
Data Mgmt
and Reporting
• Routine and
safety analysis
• Advanced
method
development and
validation
• Analytical
expertise
• Dedicated and
locally based staff
• Real-time query
resolution
• Training & multi-
lingual help desk
• Lab manuals and
instructions
• Study-specific kit
building
• Quality control
• In-house frozen
logistics support
• Collection kit
inventory
monitoring
• Planning,
tracking and
reporting
• Preparations
shipping and
customs
documentation
• Integrated single
database
• Electronic data
transfer
• 21CFR Part 11 –
compliant
reporting
technology

7. ©2012, LabConnect LLC. All rights reserved.
Project Management
Project Managers/Project Coordinators
• Primary point of contact
• Oversight of routine project team meetings
• Online collaborative tools
• Ensure set-up is completed in accordance with
the protocol and SOW
• Ensure all deliverables are achieved
Investigator Training and Support
• Customized testing schedule, training
Materials and laboratory manuals
• Pre-labeled laboratory collection kits
• Continually ranked highest in customer
service compared to other central labs
An Experienced Project Manager will be Assigned
to Your Study

8. ©2012, LabConnect LLC. All rights reserved.
Collection Kits & Supplies
Customized Collection Kits for Your Study
• Custom kit design
• Laboratory requisition form
• Specimen pressure vessel (IATA
compliant)
• Error mitigation due to
pre-labeled collection tubes
• Shipper with pre-printed air bill
• Thermos protection wrap
(during hot weather)
• Absorbent cryovial sleeve
• Monitored and checked by QC
prior to delivery to site

9. ©2012, LabConnect LLC. All rights reserved.
BioRepository
• State-of-the-art 15,000-square-foot main
facility
• 1 million sample capacity
• -20°C biomedical laboratory freezers
• -70°C ultralow freezers
• Aliquot-specific computerized tracking
system
• 24-Hour computerized temperature
monitoring with alerts
• Full redundant backup
BioRepository Capabilities

10. ©2012, LabConnect LLC. All rights reserved.
Sample Management
• Delivery times are monitored and corrective
action taken as needed.
• Dry run shipments are conducted to
determine transport times and aid in courier
selection.
• Samples can be delivered from sites to
laboratory within 24-48 hours.
• is a preferred partner of
LabConnect on frozen shipments.
Primary Couriers:

11. ©2012, LabConnect LLC. All rights reserved.
SampleGISTICS
SampleGISTICS: Tracking Samples via Digital Pen
Sites Central Lab
Lab 3
Lab 1
Lab 2 Biostorage
Database
• Clear sample visibility from investigator sites to each participating lab
• Creates one database for tracking multiple samples
• Generates comprehensive real time sample tracking
• Integrates data into a user-friendly reporting system

12. ©2012, LabConnect LLC. All rights reserved.
SampleGISTICS
Data Transmission/Review
SampleREACH
WEB PORTAL
Virtual
Accessioning
• Form review
• Queries
generated
• Data submission

13. ©2012, LabConnect LLC. All rights reserved.
SampleGISTICS Dashboard
DEMO
DEMO
SampleGISTICS

14. ©2012, LabConnect LLC. All rights reserved.
• Specimens received at LabConnect
• Specimens checked against requisitions
• Sites contacted immediately regarding discrepancies
• Specimens routed to testing facility
• Frozen specimens entered into FreezerWorks
Sample Management & Reporting
Accessioning Process

15. ©2012, LabConnect LLC. All rights reserved.
Data Management & Reporting
• Results can be BLINDED
– Only authorized users can have access to
BLINDED RESULTS
– Unauthorized users will see “BLINDED” on
the report
• Results can be suppressed
• Alerts
• Flags
• Notifications
• Ability to HOLD reports until tests are complete
so the Site Investigator signs a single, complete
report
Customized Reporting Approach

16. ©2012, LabConnect LLC. All rights reserved.
Data Management & Reporting
Same Day Delivery Available Through Various Platforms

17. ©2012, LabConnect LLC. All rights reserved.
Data Management & Reporting
Introduction to BioVisualization
• A unique platform that enables effective
data mining and clear interpretation of
important trends
• Customizable charts and graphs are
generated at the push of a button to
provide a wealth of insights (onsite
training available)
• Provides increased efficiency in
analytical research, as figures are
downloadable for ease of sharing with
colleagues and incorporation into
reporting documents
• Track and alert features for critical
sample analytics

18. ©2012, LabConnect LLC. All rights reserved.
BioVisualization Demo

19. ©2012, LabConnect LLC. All rights reserved.
•SampleGISTICS
•Sample Tracking
•Data Management
Early
Development
Services
•Sample Disposition
•Data Management
•Clinical Study
Management
Biological Sample
Management •Sample/Data
Management
•Clinical Study
Management
•Scientific Support
•Regulatory
Documentation
Test Site
Coordinator
Services
Bioinformatics (BioViz)
Contract Management Services
Clinical Tissue Research Scientific Support/Writing
Bio-
Storage
Collection
Materials
Logistics
Central Lab Scientific Operations
SciOps

20. ©2012, LabConnect LLC. All rights reserved.
Client Satisfaction Survey
LabConnect Service Area Ratings (completed Mar 2012)

21. ©2012, LabConnect LLC. All rights reserved.
Site Satisfaction Survey
Investigator Site Survey : Sites were asked to select the best
performing lab in each category
*Cumulative through Q2 2014
Source: 800+ investigative site surveys. N.B.: responses can exceed 100%

22. Global Headquarters & Sales
605 First Ave. Suite 300
Seattle, WA USA 98104
Jeff Mayhew, Chief Development Officer
jmayhew@labconnectllc.com
(206) 322-9149
www.labconnectllc.com