Check out this presentation from PAREXEL Randomization and Trial Supply Experts to learn about temperature monitoring practices throughout the clinical trial supply chain, including: traditional temperature monitoring methods, innovative methods and how to apply the best approach to individual studies.

1. © 2018 PAREXEL INTERNATIONAL CORP.
IMPROVING
PROCESSES FOR
TEMPERATURE
TRACEABILITY
FROM PACKAGING
TO PATIENT
Tim Gilbert
Senior Director, Product Management, Randomization and Trial
Supply Management

2. © 2018 PAREXEL INTERNATIONAL 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 PAREXEL INTERNATIONAL CORP. / 3
DUBLIN, IRELAND
TEMPERATURE
MONITORING

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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.

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TRADITIONAL LOGGERS
USB
loggers
Fridge
loggers

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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!

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TAIPEI, TAIWAN
INNOVATIVE
METHODS
OF TEMPERATURE
MONITORING

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Solution 1: Near Real-time Temperature
Monitoring

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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

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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

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Solution 2: In Pack Bluetooth Enabled
Temperature Monitoring

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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

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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

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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

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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

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DUBLIN, IRELAND
CHOOSING THE BEST
APPROACH

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TOO MANY OPTIONS? WHICH IS RIGHT FOR MY STUDY?
A E
B D
C
F I
HG

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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!

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LONDON, U.K.
CASE STUDY 1:
PERSONALIZED MEDICINE

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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

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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

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TOKYO, JAPAN
CASE STUDY 2:
9 MONTH VACCINE
STUDY

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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 PAREXEL INTERNATIONAL 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 PAREXEL INTERNATIONAL CORP. / 25
BOSTON, MASSACHUSETTS
CONCLUSION

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The need for temperature
monitoring is increasing
Technology must streamline the
process, not inhibit it
Choose the best solution for your
study
CONCLUSION

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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

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THANK YOU
© 2018 PAREXEL INTERNATIONAL CORP. / 28