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 -20C biomedical laboratory freezers -70C 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