applying the internet of things to the clinical trial supply chain

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


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


CMO

3PL

CROIRT DEPOT

COURIER

CRA

DATA MGR

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IoT ENABLED CLINICAL TRIAL SUPPLY CHAIN


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


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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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Allocating & dispensing

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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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SUMMARY



Identifyand resolve

issues rapidly


to reduce risks and

costs

37


SUMMARY



Identifyand resolve

issues rapidly


to reduce risks and

costs

38


SUMMARY



Identifyand resolve

issues rapidly


to reduce risks and

costs

applying the internet of things to the clinical trial supply chain

Healthcare