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Improving Processes for Temperature Traceability from Packaging to Patient
The document discusses the importance of temperature monitoring in clinical trials and explores traditional versus innovative methods for improving temperature traceability. It highlights the need for advanced solutions due to regulatory requirements and the impact on patient safety, showcasing case studies that demonstrate effective applications of near real-time and in-pack temperature monitoring technology. The conclusion emphasizes the necessity of selecting the right temperature management solution to streamline processes in clinical research.
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Improving Processes for Temperature Traceability from Packaging to Patient
- 1. © 2018 PAREXELINTERNATIONAL CORP. IMPROVING PROCESSES FOR TEMPERATURE TRACEABILITY FROM PACKAGING TO PATIENT Tim Gilbert Senior Director, Product Management, Randomization and Trial Supply Management
- 2. © 2018 PAREXELINTERNATIONAL CORP. / 2 THIS SESSION WILL COVER: • Traditional Methods of Temperature Monitoring • Drivers for Temperature Monitoring • The Need to Innovate • Innovative Methods of Temperature Monitoring • Applying the Best Approach to Individual Studies • Case Studies • Conclusion AGENDA
- 3. © 2018 PAREXELINTERNATIONAL CORP. / 3 DUBLIN, IRELAND TEMPERATURE MONITORING
- 4. © 2018 PAREXELINTERNATIONAL CORP. / 4 SUPPLY CHAIN TEMPERATURE MANAGEMENT WHY IS THIS A “HOT” TOPIC? Advancing GDP Regulation Increasing Requirement for Temperature Monitoring Increasing Burden on Site and Sponsor Staff Innovative Solutions Required to Mitigate the Impact! Improved Safety Assurance! 40% healthcare products temperature sensitive (1) Cold Chain for 80% of top 10 biopharma products by 2020 (2) References 1 “Global Trends in Clinical Trial Logistics: 2020 Perspective.” 2015. Corex. Accessed at http://tiny.cc/amlu5x on November 9, 2015. 2 Ibid.
- 5. © 2018 PAREXELINTERNATIONAL CORP. / 5 TRADITIONAL LOGGERS USB loggers Fridge loggers
- 6. © 2018 PAREXELINTERNATIONAL CORP. / 6 SUPPLY CHAIN TEMPERATURE MANAGEMENT HOW CAN TECHNOLOGY IMPROVE PROCESSES? Site • Remove burden on sites Quality/ Audit • Reliable “lifetime” temperature data record Patient • Reduce risk of patient waiting / dropping out Supplies Mgt • Minimize medication wastage All • Reduced dispensing risk Combining innovative temperature monitoring solutions with a user friendly interface revolutionizes clinical trial design!
- 7. © 2018 PAREXELINTERNATIONAL CORP. / 7 TAIPEI, TAIWAN INNOVATIVE METHODS OF TEMPERATURE MONITORING
- 8. © 2018 PAREXELINTERNATIONAL CORP. / 8 Solution 1: Near Real-time Temperature Monitoring
- 9. © 2018 PAREXELINTERNATIONAL CORP. / 9 REAL-TIME TEMPERATURE Packaging Near Real-Time Temperature Logger placed in shipment Distribution from Depot to Sites IRT System for automatic analysis, quarantine and release NEAR REAL-TIME TEMPERATURE MONITORING
- 10. © 2018 PAREXELINTERNATIONAL CORP. / 10 BENEFITS OF NEAR REAL-TIME TEMPERATURE MONITORING • Simplify arrivals process for sites • Automate material status in IRT • Alert sponsors to excursions earlier • Reduce time medication stays in quarantine • Meet regulatory audit needs Help ensure drug is always available on-time
- 11. © 2018 PAREXELINTERNATIONAL CORP. / 11 Solution 2: In Pack Bluetooth Enabled Temperature Monitoring
- 12. © 2018 PAREXELINTERNATIONAL CORP. / 12 IN-PACK TEMPERATURE MONITORING PROCESS MANUFACTURING/ PACKAGING DEPOT CLINICAL TRIAL SITE Logger placed in pack Logger programmed with temperature profile Logger remains in pack in storage at site Bluetooth read before dispensation Logger packed in medication box/pack Logger stays with pack in fridge Gateway devices at depots / sites Pack placed in shipment & shipped to site
- 13. © 2018 PAREXELINTERNATIONAL CORP. / 13 NEW AND OLD PROCESS: ARRIVALS & STORAGE Arrivals- Current process (IWR only) Collect shipment & unpack Enter and confirm shipment & pack details in IWR. Input date and time of receipt Manual logger data upload/ email CRA Place in storage with fridge temperature logger Check of packs against pack list (Paperwork ) Risk of human error Duplication of effort (paperwork + IWR) Fridge loggers not integrated with IRT system Separate Quarantine Process Arrivals: New Process (IWR + Mobile Barcode scanning + BLE) Check shipment arrived & unpack Collect shipment & scan to confirm Bluetooth discovery shows packs present & confirms temperature status Place in fridge storage Mobile notifies of any packs to be quarantined Removes risk of human error Damaged packs trigger re-order BLE discovery scan at any point to Confirm packs are not compromised Improved end-end data traceability One logger per pack- end to end temperature history
- 14. © 2018 PAREXELINTERNATIONAL CORP. / 14 NEW AND OLD PROCESS: ALLOCATION & DISPENSATION Allocation & Dispensation: IWR + Mobile Barcode Scanning + BLE Patient attends visit. Vitals entered into Mobile Pharmacy collects pack, checks dose & labels Use of convenient device in same location as patient Packs not allocated unless most recent BLE scan OK Assurance the CORRECT & uncompromised kit(s) are dispensed Mobile calculates dose & allocates kit(s) Allocation & Dispensation- Current Process (IWR only) Patient attends visit. (Nurse takes vitals) Nurse collects pack(s) IWR calculates dose & allocates pack(s) Request sent to pharmacy who collect pack, check dose & label Nurse check patient details & doses. Confirmed in IWR Assumptions made about temperature status Duplication of effort (paperwork + IWR) IWR often in different location How is the IMP stored once labelled? Automatic Bluetooth scan Nurse collects & scans to confirm identity of kit Dispensation to patient BLE discovery scan at any point to Confirm packs are not compromised
- 15. © 2018 PAREXELINTERNATIONAL CORP. / 15 BENEFITS OF IN-PACK TEMPERATURE MONITORING • End to end traceability from depot to dispensation • Simplify arrivals process for sites • Final safety check on dispensation • Upload data from multiple loggers in one scan • Automate material status in IRT • Reduce time medication stays in quarantine • Meet regulatory audit needs Bluetooth enables an efficient & reliable status check which ensures safe drug dispensation
- 16. © 2018 PAREXELINTERNATIONAL CORP. / 16 DUBLIN, IRELAND CHOOSING THE BEST APPROACH
- 17. © 2018 PAREXELINTERNATIONAL CORP. / 17 TOO MANY OPTIONS? WHICH IS RIGHT FOR MY STUDY? A E B D C F I HG
- 18. © 2018 PAREXELINTERNATIONAL CORP. / 18 MAXIMIZING THE BENEFITS FOR YOUR STUDY Considerations Patient Safety Near-real time monitoring Site user experience Logistical improvements Drug production cost Market competition Prioritize the considerations Which solution matches the study needs? Improve safety assurance & streamline processes!
- 19. © 2018 PAREXELINTERNATIONAL CORP. / 19 LONDON, U.K. CASE STUDY 1: PERSONALIZED MEDICINE
- 20. © 2018 PAREXELINTERNATIONAL CORP. / 20 CASE STUDY 1: PERSONALIZED MEDICINE Near-real time monitoring Assurance of correct IMP Speed of processing arrival What are the needs of this study? Minimal training requirements Drug Development Cost
- 21. © 2018 PAREXELINTERNATIONAL CORP. / 21 CASE STUDY 1: PERSONALIZED MEDICINE Near-real time monitoring Assurance of correct IMP Speed of processing arrival What are the needs of this study? Minimal training requirements Which solution is optimum? Near Real-time Temp. Monitoring Considerations Patient safety Near real-time monitoring Drug development cost Logistical improvements Site user experience Market CompetitionDrug Development Cost
- 22. © 2018 PAREXELINTERNATIONAL CORP. / 22 TOKYO, JAPAN CASE STUDY 2: 9 MONTH VACCINE STUDY
- 23. © 2018 PAREXELINTERNATIONAL CORP. / 23 CASE STUDY 2: 9 MONTH VACCINE STUDY On site temp monitoring & long logger battery life Final check on dispensation Site user experience What are the needs of this study? Minimal training requirements Automatic resupply Market competition
- 24. © 2018 PAREXELINTERNATIONAL CORP. / 24 CASE STUDY 2: 9 MONTH VACCINE STUDY On site temp monitoring & long logger battery life Final check on dispensation Site user experience What are the needs of this study? Minimal training requirements Automatic resupply Market competition In-Pack Bluetooth Enabled Temperature Monitoring Considerations Patient safety Site user experience On site temp monitoring Logistical improvements Market competition Drug Development Cost Near real-time monitoring Which solution is optimum?
- 25. © 2018 PAREXELINTERNATIONAL CORP. / 25 BOSTON, MASSACHUSETTS CONCLUSION
- 26. © 2018 PAREXELINTERNATIONAL CORP. / 26 The need for temperature monitoring is increasing Technology must streamline the process, not inhibit it Choose the best solution for your study CONCLUSION
- 27. © 2018 PAREXELINTERNATIONAL CORP. / 27 QUESTIONS For more information: Tim Gilbert, Colette Thorold or Julia Lakeland Product Management RTSM Tim.Gilbert@PAREXEL.com Julia.Lakeland@PAREXEL.com Colette.Thorold@PAREXEL.com Come and see us at PAREXEL’s booth! Visit our Informatics resource portal at: https://informatics.parexel.com
- 28. © 2018 PAREXELINTERNATIONAL CORP. / 28 THANK YOU © 2018 PAREXEL INTERNATIONAL CORP. / 28
Editor's Notes
- #28 Andreas address shall remain as a second contact besides the presenter