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Preclinical Services

Preclinical Services. Overview. Updates GLP Progress Open Projects New Assays Pathology Capacity Roles and expectations of RST Futures How to improve services How to improve alignment within the labs. GLP Update. QA assessment of current lab state in progress

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Preclinical Services

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  1. Preclinical Services

  2. Overview Updates • GLP Progress • Open Projects • New Assays • Pathology Capacity • Roles and expectations of RST Futures • How to improve services • How to improve alignment within the labs

  3. GLP Update • QA assessment of current lab state in progress • North Grafton audit complete • QA approval of several past GLP projects • New projects are being identified • High level timeline created

  4. GLP Task Overview ¹Hiring and training concurrent in beginning phases of project. ²Construction must be completed before Equipment installation and GLP readiness ³All current archived validations will need review and be redone if GLP requirements not met.

  5. GLP Implementation Timelines 2013-2014 Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Build QAU¹ Create GLP Histo Lab² Create GLP Clin Lab GLP ¹Assumes QA FTE hired and trained by end of Q3’13 ² Assumes Lab Buildout complete by Q1’14

  6. Open Projects 1. Reporting Limits Reference Document • Define reporting limits for chemistry to use as a customer education tool. 2. Improved scroll submission forms • Drag and drop excel format for large customer submissions

  7. New Assays Now – Data Collection • Collecting information from our sales team and send outs • Assessing which tests are meaningful and have longevity Next – Action • Alert Marketing • Determine how to validate test and secure resources • Communicate, communicate, communicate……… • Go Live!

  8. Tomorrow Pathology Coordinator Histology Addition Gap in Clinical coverage Clinical gap filled Pathology TATs improved Consult Services increased Today Pathology Capacity

  9. Improve Services • Creation of panels for specific testing • Add Pathology/Scientist availability for in-depth study consult • Electronic Result Delivery options and overall IT support

  10. Improve Labs Alignment (Preclin/RADIL) • Current Challenges • Separate LIMs/ Resulting • Separate Billing • Separate accounts • DOS is can be confusing to customers Where do we go from here?

  11. Roles of RST • Answering Customer calls • Delivering results • Account Set-up • Sales informant • Courier pick up/help • Liaisons for the lab • Supply Fill • GCP/PC Kit assembly and site ship

  12. Additional Ideas

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