Applying IoT to Clinical Trial Supply Chain
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Applying the Internet of Things to the Clinical Trial Supply Chain by Andrea Zobel and Andy Gurd
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Applying IoT to Clinical Trial Supply Chain
- 1. APPLYING IOT TO THE CLINICAL TRIAL SUPPLY CHAIN 10 May 2016 Andrea Zobel and Andy Gurd
- 3. 3 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
- 4. 4 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 suppliers Visibility of location and quality of supplies is limited Difficult to get an aggregated view No tracking to patient’s home
- 5. 5 TODAY: TYPICALLY SILOED SUPPLY CHAIN DATA MANUFACTURER DEPOT CLINICAL TRIAL SITE PATIENT’S HOME CMO 3PL IRT DEPOT CROCRA DATA MGR Data only visible at end of journey Data only visible at end of journey No visibility
- 6. 6 IoT ENABLED CLINICAL TRIAL SUPPLY CHAIN MANUFACTURER DEPOT CLINICAL TRIAL SITE PATIENT’S HOME CMO 3PL CRO IRT DEPOT COURIER CRA DATA MGR
- 7. 7 IoT ENABLED CLINICAL TRIAL SUPPLY CHAIN MANUFACTURER DEPOT CLINICAL TRIAL SITE PATIENT’S HOME CMO 3PL CRO IRT DEPOT COURIER CRA DATA MGR Visibility & control Cost & risk reduction Compliance
- 8. 8 LACK OF ACCESS TO DATA TO DIAGNOSE PROBLEMS AND TAKE REMEDIAL ACTIONS
- 9. 9 GAIN TIMELY ACCESS TO DATA TO IDENTIFY AND RESOLVE PROBLEMS SOONER
- 10. 10 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
- 11. 11 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)
- 12. 12 MORE CLINICAL TRIAL SUPPLIES ARE TEMPERATURE-SENSITIVE 3/4 of biological drugs 10-15% small molecules All vaccines Biological samples and diagnostics tools Increasing number of products requiring temperature control (‘cold chain’)
- 13. 13 Comply with regulations Protect supply integrity and patient safety Optimize supply routes TRACEABILITY IS GROWING IN IMPORTANCE Prevent / detect loss / theft of high-value or controlled drugs
- 14. 14 PROACTIVE CLINICAL TRIAL SUPPLY CHAIN CONTROL WITH NEAR-REAL TIME MONITORING MANUFACTURER DEPOT CLINICAL TRIAL SITE PATIENT’S HOME
- 15. 15 MANUFACTURER DEPOT CLINICAL TRIAL SITE PATIENT’S HOME PROACTIVE CLINICAL TRIAL SUPPLY CHAIN CONTROL WITH NEAR-REAL TIME MONITORING Full traceability No data gaps No hand-overs Patient safety
- 16. 16 FACILITIES PAREXEL 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
- 17. 17 AUTOMATING ACTIONS BASED ON TEMPERATURE LIMITS IN IRT (IVR/IWR)
- 18. 18 SHIPMENTS ALREADY MARKED AS DAMAGED OR QUARANTINED AT SITE ARRIVAL
- 20. 20 EXTENDING MONITORING TO SITES
- 21. 21 CUMULATIVE TEMPERATURE FOR TRANSIT & STORAGE
- 22. 22 SAVE EFFORT AND INCREASE ACCURACY
- 23. 23 COMPLEXITIES FOR SITES Returns & reconciliationAllocating & dispensingArrivals Study nurse Pharmacy tech Shipment Paperwork Temperature logger Spreadsheets IRT Patient Pharmacy tech Prescription Phone call from pharmacy to confirm dispensed Paperwork Kits & labels IRT Doctor Patient Pharmacy tech Returned meds Pill counter IRT Study nurse Paperwork
- 24. 24 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
- 25. 25 HOW A MOBILE APP FOR SITES CAN HELP Arrivals
- 26. 26 HOW A MOBILE APP FOR SITES CAN HELP Allocating & dispensing
- 27. 27 HOW A MOBILE APP FOR SITES CAN HELP Returns & reconciliation
- 28. 28 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
- 29. 29 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
- 30. 30 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?
- 32. 32 EXTENDING INTO THE PATIENT'S HOME
- 33. 33 POLL QUESTION Are you considering IoT (wearable / sensor) technologies for patients? • A: already in usage • B: in set-up • C: planned • D: not yet
- 34. 34 CMO CRO IRT DEPOT COURIER CRA DATA MGR A MISSION CONTROL CENTER FOR CLINICAL SUPPLIES & OPERATIONS 3PL SITES PATIENTS
- 35. 35 Gain better insights to reduce risks and costs Reduce effort and improve accuracy at sites Extend visibility and control in the future SUMMARY Identify and resolve issues rapidly
- 36. 36 Reduce effort and improve accuracy at sites SUMMARY Extend visibility and control in the future Identify and resolve issues rapidly Gain better insights to reduce risks and costs
- 37. 37 Reduce effort and improve accuracy at sites SUMMARY Extend visibility and control in the future Identify and resolve issues rapidly Gain better insights to reduce risks and costs
- 38. 38 Reduce effort and improve accuracy at sites SUMMARY Extend visibility and control in the future Identify and resolve issues rapidly Gain better insights to reduce risks and costs
Editor's Notes
- Good morning and thank you all for attending our event today. This initial sessions explores how mobile, cloud and big data analytics can be utilized to improve control and visibility within your clinical supply chain. I’ll like to talk about 2 areas – firstly how active tracking technologies can be integrated into the entire supply chain and secondly how mobile technologies can be used to simplify the life of your clinical trial sites. I’ll conclude with some comments about how technology may help us to extend the reach of the supply chain to the patient and provide some other food for thought ahead of our discussion session this afternoon. I am joined by my colleague, Richard Speed, who will run a demonstration for us in a few moments.
- In the childhood game of pin the tail on the donkey you were blindfold and just had to guess where you needed to place the pin. In the clinical trial supply chain you can lack visibility into what’s going on in the journey from manufacturing to the patient making it difficult to make course corrections to optimize the supply chain. With mobile, cloud and analytics technologies, you can gain better insights enabling you to proactively manage issues and more accurately predict supply chain behavior because data are available faster than now and can be fed directly into central databases avoiding time consuming paperwork.
- So let me start by talking about what is called The Internet of Things. We obviously live in a highly connected ecosystem of smartphones, wearable and other devices that are used by people in their everyday life. We also live in a world dominated by cloud computing, big data and analytics. Whilst our industry is clearly starting to understand how these technologies can improve clinical discovery and development, the clinical trial space is still behind adoption in other industries or is using the approaches the technologies offer, without connectivity or ability to exchange data in near real time or ability to use data collected over many trials to optimize design and implementation. Lets think about how this can be applied and talk about how this can change the way you manage your supply chain.
- As you all probably know the term ‘supply chain of custody’ refers to the complete journey of clinical trial supplies from manufacturing through regional hubs and local depots, to investigational sites and ultimately to the patient. We also include the reverse logistics through the reconciliation and return processes. This journey involves periods of storage, repackaging, and shipments and need full control and documentation of all steps. When viewed end-2-end it is actually quite complex. Today the workflow, processes and technologies of the many service providers in the supply chain (such as CMOs, couriers, IRT systems, CROs, sponsors, etc.) are largely disconnected, making it difficult to get an end-to-end view and an audit trail that covers the location and condition of your supplies at any moment in time.
- Of course each of these players in the supply chain have their own technologies and databases and today a lot of energy is expended putting these data together to support workflow between organizations and visibility of supply chain performance. A consequence of having this data in silos is that the ability to aggregate data across studies and use the experience of conducting many 100’s of clinical trials to optimize future study design can also be very complicated. For example, as we’ll see in our demonstration, today temperature excursion data from temperature loggers used in clinical supply is often not available until the end of the journey. This means it is not always possible to proactively respond to an excursion ahead of materials reaching a site and therefore assure continuity of supply to sites and patients.
- As we will show, the IoT provides the potential to start to link these systems and datasets together through the supply chain of custody using both mobile device and cloud technologies. This will provide centralized data capture that will enable an immediate view into the status of your supplies to proactively manage issues. As data is accumulated, aggregated analytics will enable you to more accurately understand and predict supply chain behaviour.
- In addition to improved visibility and control, other benefits here will include the opportunity for cost and risk reduction as well as improved compliance with regulatory compliance.
- The analogy here is to think of 19th century doctors who had limited diagnostics tools and communication ability across specialities. As a consequence, those doctors had limited insights into what’s wrong with the patient, making rapid and accurate diagnosis and remedial treatment challenging. Additionally it took time for clinical evidence of effectiveness of treatments to accumulate which in turn made patient outcomes difficult to share and treatment regimens difficult to optimize. This is not so unlike the conventional clinical trial supply chain where you have separate data islands and lack timely access to data into inventory availability, location and environmental factors like temperature, humidity, shock thus impairing and delaying your ability to take remedial actions.
- Fast forward and today’s doctors have an an array of diagnostic equipment and are interchanging information on outcomes in near real-time. With the greater and timely access to data the doctor can deliver faster and more accurate treatment and can harmonize their treatments. In the clinical trial supply chain, what if there were greater visibility of the status of the supplies, enabling any problems to be detected early and remedial actions taken sooner? What if the connection hand-overs in the supply chain are supported by automatic data transfer instead of manual read-outs and communication via email or fax? Think also how you can use the cumulative data of all the trials you are conducting to improve your design and decisions in the supply chain. Before we look at one way in which that could be achieved let me first ask you some questions….
- Can you answer these questions about your clinical trial supply chain?
- Can you answer these questions about your clinical trial supply chain?
- The first example of how the IOT an be applied concerns what we call the Active Tracking of temperature sensitive materials. Why is this important? Well, firstly more drugs, samples and diagnostics tools need temperature control. At least 20% of clinical trial supplies require cold chain handling (2 to 8 degrees C) today. Growth in biologics and personalized medicines will drive this up. By 2020, it is estimated that around 8 of the top 10 pharma products will require cold chain handling. Ambient products may also need monitoring especially in the early phase of your clinical trails when limited stability data are available.
- Therefore for these reasons the ability to be able to get visibility into the supply chain becomes very increasingly important. Traceability will enable us to: Protect supply integrity and patient safety by detecting delays and diversions of materials Prevent / detect loss / theft of high-value or controlled drugs Optimize supply around problematic locations such as specific airports And importantly comply with regulations
- In a moment Richard will walk through a demonstration of the approach we are taking within PAREXEL. We are developing tracking solution that can be applied throughout the supply chain, or just parts of it, and how we can use the data to show the integrity of supplies at any point or location in that supply chain. The active tracking solution is tightly integrated into our current ClinPhone RTSM platform and enables the system to make better informed decisions concerning, for example, drug dispensation. At the same time the solution will develop a warehouse of clinical supply data that then can be used to help design better supply implementations in the future.
- As you will see the approach enables full near real-time traceability of location and the environmental condition if your supplies and has the ability to eliminate data gaps and hand-overs in your supply chain of custody with a view to ensuring risk is reduced and patient safety is improved. So on that note I would like to hand over to Richard to walk us through the demonstration.
- PAREXEL’s Clinical Trial Supplies and Logistics unit ran a pilot of the near-real time monitoring capability where we tracked shipments out of our European Distribution Center in Berlin to our Singapore Distribution Center, our depots in Japan and Brazil; from the Brazil depot to a Brazilian site and from the EU Distribution Center to PAREXEL offices in Germany, acting as sites.
- Med arrival form for end user shows shipments as already damaged or quarantined with helpful message (Phase 1)
- Monitor tools to view temperature (line), cumulative excursion (area) and location (pop-up) – Phase 1
- Assigning kits to site loggers during med arrival to increase cumulative monitoring (Phase 2)
- Showing cumulative temperature (line is temp, area is cumulative) for transit and storage (Phase 2)
- Thank you Richard. Before I move on let me pause here in case anyone has any questions – we’ll have time at the end for questions as well. Let me know talk about how the IoT can be used to simplify and improve accuracy within the supply chain and from the perspective of the study site. Our analogy here is found in supermarkets. Supermarkets today have adopted technologies resulting in very accurate just-in-time stock control through the use technologies such as of barcoding and scanners combined with big data analysis to predict demand and supply chain performance.
- If we think of the clinical trial site, and the main functions the site performs in the clinical supply chain – i.e. Material receipt and inventory, allocating and dispensing materials to patients and accounting and handling returns and reconciliation – again all of these processes are quite complicated, require sites to work across multiple systems in some cases or are still largely paper based, can be time consuming and can also be prone to critical error such as an incorrect kit allocation to a patient. I won’t spend time talking about the detail in each of these functions but I think we will all agree that in all of these processes there are lots of opportunities for manually recorded data to be incorrect or inconsistent across paperwork, files and the IRT systems. Let me show you how the IOT and in this case mobile technologies can assist.
- Firstly mobile app technology can be added to IRT systems to reduce the administrative burden on sites, improve data accuracy, timeliness of data and therefore reduce the potential for inconsistent and out of date data. As an example we are showing the medication arrival process. As well as using barcode capabilities to confirm identify of received shipments and kits, you can use the mobile device’s camera to record the damage before marking the item as quarantined. Our approach is to enable this to work both online and offline and through a very simple, intuitive user interface that controls the workflow.
- Another example is the critical process of allocating and dispensing a kit to a patient. You could have an QR code on a patient ID card or eCRF that can be scanned to identify the patient. As you can see here the app then displays which packs are allocated to that patient. You scan in the packs to confirm the correct dispensing of those packs to that patient.
- Finally as medicines are returned the pack can be scanned, details of the pack and patient allocation displayed, photo taken and the app used to mark used or unused medicine – clicking over empty or full blisters in this example, or perhaps marking a line on a bottle (for liquid medicines). What I have shown you here is the enablement of workflow through the mobile device that is easy to use and intuitive from the sites perspective. Similar approaches can be developed for others users within the clinical trial process including depots and also patients. Having heard and seen this, let me ask another question…
- Current Process Find out if shipment has arrived – check with reception or receive late arrival alert. This could be typically be done by a study nurse. Collect shipment Enter shipment details and confirm status in IWR Plug in logger and upload temperature data For each medication pack, enter details and confirm status in IWR Place medication in stock for use
- With RTSM app and real-time temperature monitoring Automatic alert on arrival from location tracking Collect shipment Scan and confirm shipment. Temperature data for the shipment is already available in the cloud (collected by real-time logging devices) Scan and confirm packs Place medication in stock for use
- Let me finish by making some comments about how the technologies you have seen can potentially extend the reach of clinical supply chain management. Lets look at a couple of examples.
- Firstly, as technology advances, in general there is a drive towards miniaturization, integration and reduced cost of ownership. New IoT technologies for temperature, other environmental factors and location are becoming smaller and more cost-effective offering the possibility of extending the ability to monitor into the patient’s home and even into the journey from the clinical trial site to the patient’s home. Likewise, BLE – Bluetooth Low Energy – technology is capable of being used to build temperature monitoring into labels. Intelligent fridges can be equipped with sensors and internet connection to alert sponsors, sites and their patients to temperature issues. All of this offers interesting possibilities. Miniaturized sensors, mobile apps and wearable devices can all help with patient reminders and compliance tracking, as well as capturing outcome assessments and additional data on patient well-being thus offering the ability to digitize the patient and change the way in which the clinical site and patient interact in a clinical trial setting.
- Secondly, as mentioned earlier, if data can be connected from all these IoT and database sources for monitoring the clinical trial supply chain; and coupled with clinical operations and data management data sources you could have the equivalent of a mission control center for a clinical trial - a centralized intelligence hub gathering and analysing real-time data and trends across multiple studies and supply chains to optimize clinical development from study design and start-up through recruitment, trial execution to study close and compliance reporting. We are already seeing this happen in clinical operations, for example in areas such as site selection, study start up and monitoring…. I think it is not too far away from being a reality in clinical supply management as well.
- So, in summary, In the future we will extend our visibility and control to the patient; and expand analytics and intelligence to the entire trial operations
- I believe we will see mobile apps and adjacent technologies reducing the burden on sites for patient and inventory management administrative and compliance tasks
- Near real-time monitoring of temperature, other environmental factors and location will enable more drug to be saved, trial delays to be avoided, patient safety / trial integrity maintained and regulations to be complied with.
- And finally, by utilizing the Internet of Things powered by mobile, cloud and analytics technologies, you can gain better insights enabling you to proactively manage issues and more accurately predict supply chain behavior. Thank you for your attention and participation, I believe we now have a few moments for questions.