Applying the Internet of Things to the Clinical Trial Supply Chain
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APPLYING IOT TO THE CLINICAL TRIAL SUPPLY CHAIN10 May 2016Andrea Zobel and Andy Gurd
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LIMITED VISIBILITY
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THE INTERNET OF THINGS (IOT)A network of physical objects (devices, vehicles, buildings and other items) embedded with electronics, software, sensors, and network
connectivity that enables them to collect and exchange data
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ISSUES WITH THE CONVENTIONAL CLINICAL TRIAL SUPPLY CHAIN
MANUFACTURER DEPOT CLINICAL TRIAL SITE PATIENT’S HOME
The supply chain of custody: from manufacturer to patient
Different, disconnected systems and suppliersVisibility of location and quality of supplies is limitedDifficult to get an aggregated viewNo tracking to patient’s home
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TODAY: TYPICALLY SILOED SUPPLY CHAIN DATA
MANUFACTURER DEPOT CLINICAL TRIAL SITE PATIENT’S HOME
CMO 3PLIRT
DEPOT
CROCRA
DATA MGR
Data only visible at
end of journey
Data only visible at
end of journey
No visibility
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IoT ENABLED CLINICAL TRIAL SUPPLY CHAIN
MANUFACTURER DEPOT CLINICAL TRIAL SITE PATIENT’S HOME
CMO
3PL
CROIRT DEPOT
COURIER
CRA
DATA MGR
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IoT ENABLED CLINICAL TRIAL SUPPLY CHAIN
MANUFACTURER DEPOT CLINICAL TRIAL SITE PATIENT’S HOME
CMO
3PL
CROIRT DEPOT
COURIER
CRA
DATA MGR
Visibility & control
Cost & risk reduction
Compliance
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LACK OF ACCESSTO DATA TO DIAGNOSE
PROBLEMS AND TAKE REMEDIAL
ACTIONS
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GAIN TIMELY ACCESS TO DATA TO IDENTIFY AND RESOLVE
PROBLEMS SOONER
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POLL QUESTION – SLIDE TO BE REPLACED BY WEBINAR POLL
Can you provide cumulative temperature data for IMPs from manufacturing to investigational sites today?
A. Yes
B. No
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POLL QUESTION – SLIDE TO BE REPLACED BY WEBINAR POLL
Which of these quality in transit measures is the most important for you to track?
A. Location
B. Humidity
C. Shock (Acceleration)
D. Temperature
E. Light exposure (Box opened)
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MORE CLINICAL TRIAL SUPPLIES ARE TEMPERATURE-SENSITIVE
3/4 ofbiological
drugs
10-15%small
molecules
Allvaccines
Biologicalsamples anddiagnostics
tools
Increasing number of products requiringtemperature control (‘cold chain’)
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Comply withregulations
Protect supply integrity and patient safety Optimize supply routes
TRACEABILITY IS GROWING IN IMPORTANCE
Prevent / detect loss / theft of high-value or
controlled drugs
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PROACTIVE CLINICAL TRIAL SUPPLY CHAIN CONTROLWITH NEAR-REAL TIME MONITORING
MANUFACTURER DEPOT CLINICAL TRIAL SITE PATIENT’S HOME
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MANUFACTURER DEPOT CLINICAL TRIAL SITE PATIENT’S HOME
PROACTIVE CLINICAL TRIAL SUPPLY CHAIN CONTROLWITH NEAR-REAL TIME MONITORING
Full traceability
No data gaps
No hand-overs
Patient safety
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FACILITIESPAREXEL Coordination Hub & distribution center
PAREXEL depot
PAREXEL local office
In network depot
In network laboratory
PROACTIVE CLINICAL TRIAL SUPPLY CHAIN CONTROL: CASE STUDY
Facilities and shipping routes
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AUTOMATING ACTIONS BASED ON TEMPERATURE LIMITS IN IRT (IVR/IWR)
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SHIPMENTS ALREADY MARKED AS DAMAGED OR QUARANTINED AT SITE ARRIVAL
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MONITOR (CUMULATIVE) TEMPERATURE
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EXTENDING MONITORING TO SITES
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CUMULATIVE TEMPERATURE FOR TRANSIT & STORAGE
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SAVE EFFORT ANDINCREASE ACCURACY
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COMPLEXITIES FOR SITES
Returns & reconciliationAllocating & dispensingArrivals
Study nurse Pharmacy tech
Shipment Paperwork
Temperature loggerSpreadsheets
IRT
Patient Pharmacy tech
Prescription Phone call from pharmacy to
confirmdispensed
Paperwork
Kits & labels
IRT
Doctor Patient Pharmacy tech
Returned meds
Pill counter
IRT
Studynurse
Paperwork
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POLL QUESTION
For which of the site tasks would an integrated workflow supported by technology be most beneficial?
• A: arrival on site
• B: dispensing
• C: return/reconciliation
• D: All equally
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HOW A MOBILE APP FOR SITES CAN HELP
Arrivals
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HOW A MOBILE APP FOR SITES CAN HELP
Allocating & dispensing
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HOW A MOBILE APP FOR SITES CAN HELP
Returns & reconciliation
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COMBINING TECHNOLOGIES TO IMPROVE THE SITE ARRIVAL PROCESS
Current Process
Check shipment arrived
Collect shipment
Enter and
confirm shipment in IWR
Upload temp. data
Enter and
confirm packs in
IWR
Place in stock
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COMBINING TECHNOLOGIES TO IMPROVE THE SITE ARRIVAL PROCESS
Current Process
RTSM Mobile App + Real-time Temperature Monitoring
Check shipment arrived
Collect shipment
Enter and
confirm shipment in IWR
Upload temp. data
Enter and
confirm packs in
IWR
Place in stock
Alert on arrival
Collect shipment
Scan and confirm
shipment
Scan and confirm packs
Place in stock
Auto.Temp. data
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0%
0%
0%
0%
0%
POLL QUESTION
1. Potential to reduce dispensing errors
2. Simplifies returns process
3. Reduces site staff burden
4. Improves data accuracy
5. Other
What do you see as the biggest advantages of applying mobile technology to site inventory management activities?
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EXTENDING REACH
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EXTENDING INTO THE PATIENT'S HOME
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POLL QUESTION
Are you considering IoT (wearable / sensor) technologies for patients?
• A: already in usage
• B: in set-up
• C: planned
• D: not yet
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CMO
CRO
IRT
DEPOT COURIER
CRA
DATA MGR
A MISSION CONTROL CENTER FOR CLINICAL SUPPLIES & OPERATIONS
3PL SITES
PATIENTS
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Gain better insights
to reduce risks and
costs
Reduce effort and improve accuracyat sites
Extend visibility and
control in the future
SUMMARY
Identifyand resolve
issues rapidly
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Reduce effort and improve accuracyat sites
SUMMARY
Extend visibility and
control in the future
Identifyand resolve
issues rapidly
Gain better insights
to reduce risks and
costs
37
Reduce effort and improve accuracyat sites
SUMMARY
Extend visibility and
control in the future
Identifyand resolve
issues rapidly
Gain better insights
to reduce risks and
costs
38
Reduce effort and improve accuracyat sites
SUMMARY
Extend visibility and
control in the future
Identifyand resolve
issues rapidly
Gain better insights
to reduce risks and
costs
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