Clinical Supply and Inventory Tracking with Siebel Clinical

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Clinical Supply and Inventory Tracking with Siebel Clinical

  1. 1. Clinical Supply and pp yInventory Trackingwith Siebel Clinical Karen Ouyang 1
  2. 2. Agenda Topic Welcome and Introductions Clinical Supply & Inventory Tracking Overview & B O i Benefits fi Approaches to Clinical Supply & Inventory Tracking in Siebel Clinical Demonstration of Different Approaches Q&A 2
  3. 3. Welcome & IntroductionsKaren Ouyang y gSenior Consultant – BioPharmSystems, Inc.• Over 6 years of experience in Siebel• 7 implementations of Siebel Clinical• Experienced in implementation, integrations, enhancement releases, and upgrades 3
  4. 4. Agenda Topic Welcome and Introductions Clinical Supply & Inventory Tracking Overview & Benefits T ki O i B fit Approaches to Clinical Supply & Inventory Tracking in Siebel Clinical Demonstration of Different Approaches Q&A 4
  5. 5. Inventory TrackingOverviewIn Scopep• Distribution of Investigational Product to Site• Distribution of Ancillary Products to SiteOut of Scope• Distribution of Investigational Product to Subject 5
  6. 6. Inventory TrackingOverviewTypical Distribution Flow yp• Manufacture to Depot• Manufacture to Site• Depot to Site• * Monitor Verify on Site• * Monitor Closeout on Site 6
  7. 7. Inventory TrackingOverviewType of Data Tracked yp• Quantity• Package Type• Lot # or Equipment #• Received at Site Date 7
  8. 8. Benefits of InventoryTracking in Siebel Clinical• Streamline clinical trial management process – Site Initiation – Site Monitoring – Site Close-out• Increase inventory l level visibility l bl• Eliminate spreadsheets tracked outside of system t id f t 8
  9. 9. Agenda Topic Welcome and Introductions Clinical Supply & Inventory Tracking Overview & B O i Benefits fi Approaches to Clinical Supply & Inventory Tracking in Siebel Clinical Demonstration of Different Approaches Q&A 9
  10. 10. Tracking Approaches• Siebel Clinical OOTB• Tracking with simple enhancements• Tracking with medium enhancements• Tracking with robust enhancements 10
  11. 11. Tracking w/ OOTBWhat It Does• Use existing Activities view under a Site to track inventory & supply to site• Add inventory & supply specific LOVs to differentiate from other site activities record 11
  12. 12. Tracking w/ OOTBHow It Works• Create a site activity record in CTMS• Select Activity Type of “Inventory”• Enter info such as quantity & lot # in “Description” field 12
  13. 13. Tracking w/ OOTBPros• No additional cost and quick to implementCons• Tracked with other non-inventoryy site activities• All info are tracked under a generic description field 13
  14. 14. Tracking w/ SimpleEnhancementsWhat It Does• Use existing Activities view under a Site to track inventory & supply to site• Add inventory & supply specific LOVs to differentiate from other site activities record• Add additional f ld to Activities dd dd l fields view to track inventory specific data 14
  15. 15. Tracking w/ SimpleEnhancementsHow It Works• Create a site activity record in CTMS• Select Activity Type of “Inventory”• Enter info such as quantity & lot # in corresponding fields 15
  16. 16. Tracking w/ SimpleEnhancementsPros• I Inexpensive cost and quick to i t d i kt implement• T Track i k inventory related data in t l t dd t i separate fieldsCons• Tracked with other non-inventory site activities• Inventory specific fields may be confusing when tracking other activity records 16
  17. 17. Tracking w/ MediumEnhancementsWhat It Does• Create a new view under a Site to track inventory & supply to site• Customize fields to track inventory specific data 17
  18. 18. Tracking w/ MediumEnhancementsHow It Works• Navigate to Supply Tracking view under a in CTMS• Create an inventory tracking record• Enter info such as quantity & lot # in corresponding fields 18
  19. 19. Tracking w/ MediumEnhancementsPros• E i t track inventory records Easier to t ki t d under separate view & fieldsCons• Only capture inventory level at the site• Does not include inventory level at manufacturer or depot 19
  20. 20. Tracking w/ RobustEnhancementsWhat It Does• Create new screens & views to track – Manufacturer & depot – Inventory transactions occur between depot & site b t d t it – Inventory level at depot & site 20
  21. 21. Tracking w/ RobustEnhancementsHow It Works• Create manufacturer & depot records• Record outbound transactions under manufacturer or depot as they occur• Track inventory info such as Date Received & # Destroyed related d d l d to each transaction under depot or site 21
  22. 22. Tracking w/ RobustEnhancementsPros• R b t inventory tracking at Robust i t t ki t depot & site level• I Increased inventory level visibility di t l l i ibilit at depot & siteCons• More efforts involved to implement• Not ideal to track ancillary supplies 22
  23. 23. Agenda Topic Welcome and Introductions Clinical Supply & Inventory Tracking Overview & B O i Benefits fi Approaches to Clinical Supply & Inventory Tracking in Siebel Clinical Demonstration of Different Approaches Q&A 23
  24. 24. Siebel Clinical Demo 24
  25. 25. Agenda Topic Welcome and Introductions Clinical Supply & Inventory Tracking Overview & B O i Benefits fi Approaches to Clinical Supply & Inventory Tracking in Siebel Clinical Demonstration of Different Approaches Q&A 25
  26. 26. Questions? 26
  27. 27. Closing Thank you for attending! This tutorial will be posted on [ [website] by? ] y 27
  28. 28. Contact Info Karen Ouyang 650-292-5312 kouyang@biopharm.com http://www.BioPharm.com 28
  29. 29. Speaker Bio Karen Ouyang Karen Ouyang is a Sr. Consultant in the BioPharm’s Siebel Practice group and has been working with Siebel for over six years years. She specializes in Siebel Clinical and her experience has been heavily focused on business process analysis, requirement analysis definition, functional design, application testing, training/change management, and system deployment. Karen is based in Los Angelas, California, and has been with BioPharm since Fall 2008. 29

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