How to accelerate clinical trials execution transformation?

Captions as YouTube publishes them, usually machine-generated, so names such as Daml and Canton can be misheard.

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   good evening everyone good morning um very happy to hear and um we've got a very interesting webinar in store for you today um discussing a topic which is pretty relevant in today's world give you an overview of how the clinical trials process is executed and what are the key challenges today uh that we encounter in getting something to market and you know a lot of data reconciliation a lot of latencies how can we help speed

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   up the process um and we'll do that in context of an overall uh overall life sciences landscape uh that we'll also outline um after that we'll give you a quick uh overview of how we could solve some of those problems using smart contracts and optionally a blockchain and we'll dig into that architecture a little bit and what that business process could look like and as we always do um we'll also you know just to keep it real and practical

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   we'll end with a demo of um an actual clinical trial process built on smart contracts and running um to show you um how the various bottlenecks in the clinical trial process can be addressed uh the demo has been built by our partner uh brillo and lakshmi is going to be outlining that uh we'll obviously keep the session pretty interactive so feel free to post your questions in the q a chat i'll um i'll uh you know keep monitoring it and i'll

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   post them to corey and lakshmi as we go along um and that brings me to introducing our panelists for the day so first off lakshmi shastri she is the principal architect at brilliant lakshmi do you want to introduce yourself yes thanks manish hi everyone i am principal architect in brillio and i have been with brilliant inception i'm primarily a technologist experienced in providing digital transformation architecture and solution strategies i'm into technology accounts and

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   consulting and solution engineering for enterprise initiatives we're using emerging technologies such as cloud big data blockchain iot and machine learning so we try to bring customer value creation and also elevate their efficiency models i'm engaged to more than a decade with life sciences companies with the rich for my experience and know-how of clinical trial process and understand its ways of working so constantly we are trying to bring the best of solution mapping to customer

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   needs and also thereby ensuring impact on businesses just to introduce a little bit on brillo uh brillo is a born digital company so we focus uh more on delivering design-led solutions for our customers uh we we do everything with the product dna mindset with agile and as a result we help customers uh to go to market faster and accelerating what matters uh faster than for them now and we also have uh more of outcome driven portfolio and innovative

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   market related solutions so that we are enabled with world-class design technology consulting and thought leadership we are primarily a business partner who can bring situational fluency who can be focused on methods and who can lead with the product mindset and wired for agility speed and precision we are located uh in uh headquartered in silicon valley and we have 18 plus offices all around the globe and we have

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   uh trusted leading brands with whom we have been been associated with a lot of our enterprise architects data scientists uh platform developers and design thinkers perfect thank you so much lakshmi yeah yeah looking forward to the discussion today and now i'd like to introduce my colleague corey todaro from digital asset corey good morning everybody i'm corey tadaro i'm the senior product manager for

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   healthcare at digital asset i work primarily in the the health for or with the healthcare industry our clients from healthcare whether that's health systems intermediaries around the claims infrastructure or data infrastructure insurance companies life sciences and pharmaceuticals as well and help them adapt and bring damo technology to their solution sets to solve distinct problems that face healthcare enterprises d.a or digital

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    asset is uh the creator of damil damil is a both a language and a technology stack to enable enterprises to run what we call cross enterprise or multi-party applications within a framework of trust within a framework of privacy uh and greater efficiency so we can redesign multi-party workflows to remove manual breaks inefficient handoffs or out-of-band workflows to improve efficiency and value creation for enterprises

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    in the healthcare space that's primarily around a number of multi-party workflows which present real challenges for enterprises on the on the healthcare delivery side that could be everything from um care coordination uh around new payment models uh how we jointly take financial risk around the outcome of a course of care uh there's lots of inefficiencies of course in the in the

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    claims and payment in financial infrastructure around health care um with with you know receivable and remittance states extending out to 30 days 45 days lots of manual reconciliation taking place anywhere we have multi-parties who have to manually reconcile or do manual handoffs within a workflow demo can provide a technology neutral and a technology agnostic solution for that problem redesigning the workflow and enabling enterprises to deploy it on infrastructure

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    that could be centralized databases or it could be fully distributed blockchains and distributed ledgers so it allows enterprises to configure a full multi-party stack while maintaining privacy security regulatory requirements and efficiency perfect yeah thank you corey thank you for that overview and uh just for people uh just as we go forward while we are also you know helping to bring damal

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    and connected networks to enterprises and consortiums who want to work together on one network ultimately the end version is also to allow multiple different networks to interoperate with each other and you will see some of that as we go forward um so lakshmi why don't you uh begin by speaking about a few technology trends that you're seeing and then we could get into the life sciences landscape and then

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    you know to set the context and then zoom into the clinical trials process yeah thanks manish so we are seeing these super power technologies influencing business across industries so digital transformation is a overall strategy which requires a strong foundation of these emerging technologies so these technologies are not just for compromising on the cost but it is also more for re-establishing long-term sustainability and also

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    ensuring we have uh outstanding customer experience experiences and also to bring in interoperability between various different purpose-built systems so that's where we see a lot of regulations and compliance needs are also asking for more and more transparency while dealing with sensitive information so we also as we go forward we also see how we are leveraging as corey mentioned uh digital asset markup language which is a

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    vendor agnostic platform which supports multiple different databases and distributed ledgers which helps us to leverage their existing investments as well as build new capabilities into uh these solutions and bring to market uh faster solutions which can focus much more on future proofing the solutions at the same time addressing the data visibility and transparency and security aspects

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    so moving forward we also see how this digital and transformation is impacting across industry and life sciences sector is one of the key a way there are a lot of digital opportunities that can be unleashed across various different life cycle while we have been working with various different customers we have engaged in their drug development in engaged with their patient enrollment and also build a

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    trust in their supply chain into end visibility of tracking and traceability and also help reshape some of their business models uh to add more values uh to one of our large pharma uh client we have built a way of classified classification of checks to x-rays where we could help to identify diseases using machine learning algorithms and custom-built custom-built algorithms where we could generate lot

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    of different standard apis to interact with multiple different systems so these hybrid algorithms help to detect a lot of patterns uh and that thereby it helped to detect whether a chest x-ray had a disease particular disease or not whether there are a lot of identified diseases we had around 14 diseases to be identified in this such as tax rates so that primarily had a huge impact on our whole life cycle so that it helped

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    doctors uh primarily to reduce uh the time that was required to generate these reports uh to identify the diagnosis and it helped almost to bring down their 60 percent of effort in report generation at the same time it also helped them to automate this patient's report generation with much more uh confidence in the data given that it had end-to-end visibility and auditing capabilities as well so preventing any kind of

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    false diagnosis in other scenarios where we have brought in life sciences to code as an example so they were smart labs which were taking lots of images of protein crystallization we using deep cnn algorithms we try to bring in and reduce the effort spent by the crystallographer in analyzing these images and tracking the various different protein crystallization stages so that

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    way it helped us to label this better and take only the valid compositions going forward to ensure that these compositions were good enough produce the different results that was expected so this is how adopting uh more of a holistic strategy uh is uh help helps life sciences better so that they can focus on more end-to-end transformation right from drug discovery to managing their clinical trials and getting their

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    regulatory reviews and approvals on time reducing the whole workflow length and duration through automation and also bring that visibility into manufacturing distribution and keeping the required dimensions and parameters in place using digital technologies today we are going to focus more on clinical trials how the digital transformation and the digital technology helps to bring in lot more efficiency into

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    this whole process so we also see that the clinical trial process has multiple intermediaries involved and generally there's clinical trial process right from patients to sponsors and regulators to you know secondary research organization there is a it requires lot of complicated data sharing sequences so that's where we try to bring in a lot of uh manual process uh to automation the desperate systems

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    where it is in siloed in nature to interoperate and also have uh more of this sensitive information to be sure shared but it also requires the required amount of transparencies so that's where we try to bring in a connected and consistent digital experience across the data flows and the end-to-end process which primarily gets api as a digital glue which ties in uh all these existing systems

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    uh which are purpose built and which has been leveraged by the industry so at the same time we are also able to build a innovative layer over and above this to bring that differentiation and also to future proof these solutions that help them to handle any unforeseen needs or the constantly changing and evolving regulatory and compliance requirements so that's where we also can build a lot more uh tailored customer experience and views

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    uh and coming to the data part uh which is the most crucial in protecting this sensitive data so that's where we can leverage uh technologies like blockchain which uh helps to bring in this transparency privacy and traceability aspects uh into whole life sensors process so so this is a fundamental uh shift where the core processes of drug research and development and increased patient safety all can be

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    emit at the same time there is a drastic reduction in the overall length of the clinical trial process by itself we also ensure we can also ensure leveraging uh blockchain and digital asset markup language together to have more of focus on developing the business logic and less of focus on infrastructure and how to set this uh whole network for blockchain so everything gets embedded and abstracted

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    with these technologies so blockchain is uh expected to improve uh the whole validity and as well as patient recruitment and retention and enrollment and we also see how uh different players or intermediaries in clinical trial process are exchanging different types of data starting from sponsor requesting for regulatory approval where he has some of the key information with respect to the drug with respect to the physical composition

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    and with respect to various different regulatory aspects that he is going to cover and uh all that is embedded uh as part of the spawn sponsor initiating the regulatory process for feasibility in the authorization once the regulator provides that authorization so next the cro would primarily ensure he agrees to the feasibility assessment does his work from his side to give a go ahead with all the

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    intellectual property and rights protection at the same time have the various scope of services and orders billing and invoice payments and how to get various different hospitals chain of hospitals onboarded onto this clinical trial process so that's where he starts building this whole administration aspect here is where we see multiple different data systems coming into play which can primarily be

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    a leverage still be leveraged uh as a clinical trial management system or health record management system but over and above that how we can help to have our own version of data to be viewed by each different intermediary so which is still guaranteeing uh primarily the logical data separation and ensuring that end-to-end visibility of the data and who is altering what part of the data and who is allowed to tamper or modify or

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    upgrade some of this data all that visibility brings in the required transparency at the same time it also helps us to leverage smart contracts which help to integrate this data and we're not having to share everything because blockchain block which contains the real-time list of records with timestamp and hash helps us to verify different provenance uh and ensure that the chain of transaction is unaltered so this this is more a

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    resistant to any kind of modification of data keeping track of end-to-end transactions and also having a open or closed membership part of the chain and ensuring also the privacy aspect that is very much critical in a clinical trial process yeah so yeah go ahead go ahead corey i was just gonna echo lakshmi um of course this is a very complex set of multiple workflows um in in this in this section of the of the healthcare industry and i just want

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    to point out a couple of things uh that we think uh is a unique value proposition of damo in enabling partners like brillo and enterprises uh to build out their solution sets and the first is the nature of the language itself and lakshmi had mentioned how damn enables you to focus purely on the business process um and when you when you write applications in demo you're you're not only defining the data model which is very standard

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    in in software but you're also at the same time also defining the um the authorization structures uh and the entitlement structures around that data model and so demo combines that such that you are guaranteed and know very easily who's allowed to see what data who's allowed to change what data um and so that even though there may be multiple participants uh use it utilizing the software um the

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    controls around authorization and timeline are very tight the second important factor around demo is one that's very common now as as the healthcare industry uh becomes more familiar with blockchain technology and that is privacy and control of the data um of course siloization in healthcare uh limits where data can go uh and then that's that's proper given the regulatory constraints um and and and the the privacy concerns around

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    the nature of this information however many blockchain infrastructures are overly broad in terms of where data is stored uh and who's allowed to see data and what demo provides uniquely uh is a configurable um a range of configurable options such that data is only stored on certain nodes uh in certain locations in certain principalities or geographical locations as well as who's allowed to see what data such that we can

40. 20:08

    not only control who can see the data we can also control where the data is stored i mean because damol is ledger agnostic being operable with with a wide variety of protocols from hyperledger fabric um to r3's cordon sawtooth vmware blockchain etc it provides the enterprises the appropriate infrastructure to meet their specific regulatory needs and concerns for their industry and not just a one-size-fits-all approach with a lot of blockchain protocols which then requires a lot of additional architectural work

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    to try to undo some of the over sharing that many blockchain protocols offer yeah yeah thanks corey i just i just want to add a couple of things there um so obviously you know um as you can see on the slide here um you know you're not limited to or dependent on one blockchain protocol so you can start with your start with your application and the business workflow and then without having to decide which blockchain to deploy it on and depending on your privacy requirements and data sharing protocols

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    you could you could obviously select the right direct blockchain that you want to deploy on um kodi uh there's one thing if you could highlight also i think lakshmi touched about it a little bit but it might be helpful to clarify that you know so um in a blockchain based network um we are not expecting each of these different parties to uh share a common blockchain uh share data on a common blockchain right um

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    they can still have the data private and segregated sure you know i i refer to it as the blockchain broadcast model um based upon a lot of the cryptocurrency protocols many blockchains offer what i call the blog the broadcast model and that is when when a party executes a transaction they broadcast that transaction to all the nodes in the network um and if we if we can think of nodes as

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    representing different parties running their own their own node within the network every node contains a record of every single transaction and that's necessary uh in some blockchain protocols to achieve consensus to make sure that we're all in sync with each other uh that all transactions are globally valid uh and we have transactional integrity that's where we see a lot of the privacy concerns and healthcare come up around blockchain uh there there is data that we cannot share with all the parties

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    uh there are regulations which uh which enforce where the data is stored physically uh geographically uh i can't store certain medical data outside the bounds of a given geopolitical entity uh so that might be a particular german state for example um the healthcare data that's generated there needs to be stored there and if i'm participating in a multi-node network that becomes almost impossible to achieve

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    what damol enables us to do is to store on your node only transactions to which you are a party or only transactions to which you've been granted some sort of observer rights to see pieces of the data perhaps the whole transaction perhaps part of the transaction perhaps only a change or a choice that's exercised by one of the other parties all of that is defined in the code itself and it's defined quite concisely such that we can meet the unique regulatory and privacy requirements

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    of the healthcare industry um without having to develop architectural workarounds around privacy and we're seeing a lot of that work take place today around a lot of the large blockchain protocols is we have to undo some of the overly broad sharing that's taking place that's that's inherent to the uh to the um to the protocol itself with demo layer sitting between the application and the persistence layer or the ledger itself we can achieve levels of privacy far more easily and

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    faster than is feasible on just what i'll call the regular protocols themselves if you were to use for example hyperledger fabric chain code or sawtooth for example you'll have to account for privacy and that is often a very painful exercise to try to adapt the protocol to the needs of the industry demo meets the needs of the industry as a first order step which enables a lot more utility and a faster time to market for your application solution yeah perfect and i think one of

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    the examples corey was you know companies might obviously use an over-the-counter or a you know purpose-built clinical trials platform but often data has to be sent to that platform and at the end of the trial or you know during the middle of the trial uh aggregated data has to be received from the platform back into the back into the farmer's infrastructure where they can do the analytics you know and uh often this back and forth of data which is being

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    uh edged and sent from one platform to the other as a batch process um often needs a lot of reconciliation a lot of matching before it can be used um so you're using a infrastructure like demil on a blockchain for example uh could could definitely alleviate that because you're not no longer sending data back and forth your uh logically accesses accessing the same same data set even

51. 25:15

    though the data set is physically segregated at different parties at different places absolutely and that's the other side of the coin excuse me when we use architectures that are built on either messaging specifications or even if we use a clinical trial platform itself that doesn't ensure interoperability or seamless unbreakable workflows with all of the parties necessary uh you know i'm i'm aware that it's not

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    just one data transfer that takes place it's a constant data transfer that takes place between cros and the operators of the trials and the sponsors themselves now i understand that that data often comes into drips and drafts and and and many companies and manufacturers and sponsors face the problem of we're receiving data constantly but that data is not indexed necessarily we're not sure what data we're receiving we're not sure if part of it is

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    repetitive if it's entirely repetitive from from a batch that ran a day ago two days ago and so it places the burden a lot of additional administrative burden on all the parties to ensure that um we've received all of the data um that we don't have repetitive data um that we don't have data that needs to be excluded um from the the final regulatory submission because of consent changes or protocol

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    changes in the trial itself and so managing all this data simply using messaging specifications uh it can be a real challenge and what we see with with sort of purpose-built platforms is that they're really designed for one or two of the parties they're not designed for all of the parties or they're not capable of accommodating to the needs of all the parties who might be involved uh in the interactions around clinical

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    trial execution and development and that's where smart contracts are really the the game-changing technology to accelerate that process because we can define um very precisely interactions between all of those parties um and not just simply serve the needs of one of the parties and just one more point i wanted to highlight that lakshmi outlined when she was defining the overall

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    life sciences value chain there are obviously going to be many many third-party or many custom applications that have been built which do very purpose-built specific things you know and uh you may not want to you may want to integrate all of that with this new infrastructure that you're setting up and that's what this diagram depicts as well these uh blue small boxes below each of the parties

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    represent those custom applications and software uh that may be in use at any of these parties um and each of that and uh you know uh that software can easily be integrated uh with the smart contract based uh multi-party distribution distributed platform so that we don't have don't have uh don't have silos you know so i think uh that's very important to say that you're not ripping and replacing everything that

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    you have but you're taking what you have and you're uh taking a hard look at it and then moving the right workflows over to your smart contract-based platform so that different parties can access you know common data but still you know segregated according to their privacy requirements with that let me see i think there's a question that has come up um so corey i think this i'm not sure if you're aware of this this question has come up uh says how can damil impact sdtm

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    and adam standards are you aware of those apologies i'm mute um standards are a common question that come up when in any sub sub-vertical in almost in any industry um there there are defined messaging state uh standards um and and data data specifications and and how does damn accommodate that uh and demo accommodates it quite well um what we do is we reveal the translation uh an integration to represent the the required data model

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    within the payload of a demo contract and it's something that we've done many times before through one of the many integration interfaces that the demo stack offers demo stack offers a very robust json api but we also have what we call a grpc interface which allows us to specify and build bridges between those messaging specs and data specifications and the demo contracts themselves it's something that we've done in financial services industries quite extensively whether that's swift messaging integration or using the common domain

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    model for uh derivatives and swaps in healthcare there's there's active work going on right now around hl7 and fire specifications x12 messaging specifications integrating in with them all contracts so that we can have an input of one data standard uh and an output of another messaging spec on the other side of the of the ledger workflow there so um with stdm and adam and i'm not an expert i don't work in those standards i'm familiar with them as being a participant and a veteran in the healthcare industry

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    although my experiences on the healthcare delivery side rather on the life sciences side building those integrations is not a challenge and damos is designed uh to accommodate these kinds of messaging and data specifications that are required within specific industries yeah perfect thank you corey um lakshmi i am unable to pull up the q a panel are you able to see i see one question

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    has come up can you see what that is it is the is the question on stdmx okay the same one okay okay so i think uh that's um so let's move on now to the to the demo uh and before we do that let's uh quickly look at the overall architecture of what that what this landscape might look like uh lakshmi do you want to elaborate a little bit on this yeah thanks uh so here uh we are briefly touching upon a clinical trial process how we are going to

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    leverage our digital asset markup language uh primarily to build a full stack cadamel application so using demo is also helping us to build this much faster this multi-party application also ensuring that we bring in a lot of focus on the business logic and this can also empower the business domain experts to rapidly create this given that it is all based on demo models and contract framework which is defined well defined for workflows and

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    authorizations but this also helps us to primarily have these multiple parties exchange the information here we can define them as signatories observers signatories are authorized to perform and create new contracts and observers primarily can see what changes are happening to these contracts and ledgers and it also has uh the two core concepts addressed very well that is authorization and privacy part

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    which was elaborately touched upon by corey and manish so our solution is primarily hosted on azure it can also leverage various different azure platform native services to ensure the web scale and also to bring in a lot of various additional functionalities for patient enrollment or being it reward to queer patients so that they can come back and ensure this end-to-end process

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    is completed as per the plan and as per the schedule so that's where this also helps to bring that coordination uh by leveraging uh the platform and various different uh capabilities of the platform it also ensure there is a logical separation of the data but also integrates very well for example the ml has connector for postgres database which uh also helps to bring in that connectivity with existing storage

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    as well as uh build a new storage with demand ledgers so that way we can still uh leverage uh existing purpose built applications which are being adopted by various different parties at the same time bring in this data standardization and consolidation layer through smart contracts which primarily helps to exchange the information and still have that privacy and transparency address through this contra contract data so

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    we also have been leveraging microsoft's open source confident consortium framework which leverages trusted execution environment uh this also brings in lot of various challenges that we see some of them related to the latency performance and it helps to address high transaction throughputs ensuring it has the same speed and while maintaining the quality of data it also ensures there is a lot more

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    governance capabilities uh built into this blockchain framework with multi-party application uh builders as well coming into the common uh framework adoption and bringing that standardization so here is where we see how the demo is going to cover the business process we start primarily with the sponsor initiating a clinical trial while he is initiating the clinical trial he he generally the quest generally request the regulator to

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    provide uh authorization to start the clinical trial process by providing all the required documents and the information that is necessary to start with the clinical trial process once the regulator gives a go ahead on this next is the step of the sponsor or the pharma company reaches out to clinical research organizations who are capable of conducting these clinical trials so there is a

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    list of standard operating procedures they need to adhere to and also ensure the intellectual property is being protected and at the same time all the enrollments that has been happening that information is protected and that the privacy is maintained so that's where the trial brochure gets the feasibility assessment happens and the trial brochure gets circulated to various different chain of hospitals who are having this patient enrollment

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    to conduct this particular kind of clinical trials uh once uh that invitation is sent to various different hospitals and also the research coordinators uh that's where these participants are participating and taking those drugs and ensuring that symptoms are being recorded so that in this covet situations they are also enabled to do this recording of symptoms at their convenience at home so that's where uh authorization needs to happen from the hospital

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    because they have to strictly adhere to some of the standard protocols and some of the medical devices that needs to be a leverage while doing this test so which can be enabled through uh video at the same time the symptoms can be recorded which goes untampered but gets authorized through you know the hospital and also there can be visits to hospital to again uh as a follow-up and as a continuation while uh it is uh feasible so this whole solution enables uh patients to

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    log their symptoms hospitals to also record the symptoms generate these reports and share these reports for approval uh again back to regulator and also ensure uh the final closure uh of this uh end-to-end process so let's uh take a look at the demo yeah so let me just before you do that just a couple of quick things so obviously lakshmi touched upon some of the new age patient engagement you know digital engagement tools and methodologies that are coming

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    up uh all of them of course sit on top of the platform that lakshmi is going to show you um so each of them can be integrated seamlessly into you know they are input into this foundational collaboration you know platform that is being that is being shown today um and the other thing i want to highlight and you'll see uh as we go through the demo is that this uh filtered and aggregated data that is being sent to various parties this uh this it's not that you know all of this data resides in a single

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    database and people have different views on it it's that um you know the data you know the individual patient level information is available at the provider for example and that as and and it automatically gets filtered as it gets sent to the cro and gets further filtered as it gets to the sponsor because you know you may not want each of the individual patient health information to be shared with the farmer for example

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    so things like those are automatically uh you know automatically filtered by the smart contracts and uh you know a distributed ledger technology supported right something we call sub-transactional privacy such that there are pieces of data within a transaction that can be preferentially shared with observers with certain rights but the whole entirety of the transaction the entirety of the data is not necessarily shared or stored elsewhere exactly yeah and while the

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    process is executing the typical processes you know the sponsor is getting all the information they'll aggregate all this information clean all the data do some analysis and finally prepare a trial report that will be shared by the regular shared with the regulator for approval um you know what the smart contracts and distributed ledger technology environment allows you to do is to output that report as a as a consequence of you executing the

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    business process so you know there's no tack on tack on steps that need to happen you know for data aggregation consolidation so you'll see some of that during the demo all right lakshmi so i'm going to uh stop sharing and um i think there are a couple of questions so we'll take those and then then you can start sharing and we can get into the demo sure okay so let me just look at the

81. 39:58

    questions um okay so one of the first question is this is a great conversation about the solution however using this approach for clinical trials would require all the participants to engage this is a big paradigm shift um so corey i can start taking this and then you can build on it um so you know this solution uh can be incrementally rolled out so for example um if you you know we mentioned the regulator automatically being a party on the

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    on the platform however uh you know when you start rolling out the platform you may not get the actual regulator to be on the you know pick up a node and be on this on this new solution platform that we've launched so what uh typically we would do is create a logical node for the regulator with that uh role of the regulator being played by for example an internal party like a compliance department or a regulatory reporting department which is automatically getting all this information and then they are sending it

83. 40:57

    over by the required channels to the regulator it still simplifies a lot of operations but you don't actually get the physical regulator on the physical network you know so you simulate that uh simulate that logical logical play yeah i would just add that that demo is what we call an extensible solution set so we can write demo templates to define specific workflows and of course the slides we've been showing are many many many workflows often enterprises will go to something that is

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    you know for lack of a better word low-hanging fruit um in terms of efficiency and value and build out a very small demo solution there we can add parties we can add adjacent workflows uh seamlessly without redesigning those core templates um there may be more workflows or or demo templates which are only affecting two of the parties uh for example and such that the other parties don't even have to be aware

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    that those workflows even exist within the solution and so damn offers you the opportunity to to start and extend beyond it without having to you know pre-configure and pre-organize the entire industry to come together around a common single solution and technology and that way it's incredibly flexible also importantly with reference to an earlier slide that manish showed the parties don't even have to be necessarily running the same uh blockchain infrastructure behind the scenes danville can enable interoperability

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    between demo solutions that work on fabric and demo solutions that work on vmware blockchain or sawtooth for example such that again we don't have to start with organizing a consortium building governance making sure everyone's on the same page before we can even begin to build the solution set we can start in the same way that all enterprise software uh projects begin which is i want to generate value i want to solve this specific business problem

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    and then we can see where it grows and it might grow in a lot of different directions but daniel doesn't close off any of those avenues and so for for partners like brilliant i think it offers a fantastic opportunity to solve the problem we have now without foreclosing future avenues exactly and you know um just to add to that uh can um tamil runs on different blockchain platforms that's

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    corey covered but demo also runs on databases uh you know if you're on azure or aws or you know any other you know cloud platform you could start streamlining your internal workflows using smart contracts to avoid all of the data reconciliation that happens within your enterprise and then you could connect that later on to the blockchain network that you might set up and that also could be set up incrementally so if you're using a

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    clinical trials platform today you could just set up a simple network between the platform and between the uh you know between the uh uh you know between the enterprise and then expand as we go along so uh yeah let's get into the let's get into the demo now and let me why don't you share your screen so this is a demo more of a a framework demonstration rather than the actual application but uh to answer some of the

90. 44:16

    questions that are there so i'll just show you how multiple parties need not have to be on the same system but still exchange information through this blockchain ledger so first let us login as the sponsor who is trying to initiate a clinical trial process so he is finally submitting approval to the professor to the regulator where he can start choosing because we have already onboarded the regulators i am not going to that

91. 44:46

    step of onboarding and we are saying for which clinical trial we are starting this clinical trial process and once we have uh shared this information with the regulator this proposal is submitted to regulator who can take a look at it he'll get notified because of various different uh additional functionalities that can be built into this system we can leverage other api integration into different notification mechanisms

92. 45:17

    and when we come here primarily the regulator is being asked to authorize a particular trial he can get access to various different documents which are stored in different systems but through this blockchain ledger as a a hash algorithm that is stored which is referencing to those documents which are still residing on the existing systems and which are not on the network to manage the privacy and the protection of the data

93. 45:48

    once the regulator is uh sorry sorry just on that um so the documents uh you know could you touch upon that a little bit obviously the documents don't all need to be on the blockchain but they could be on any you know all of the participants secure platforms as they need to be um and only a reference to that to those documents can be stored on the blockchain so we don't need to actually store all of the personal information on the

94. 46:12

    blockchain the other question that just came up is about um you know not everybody needs to be onboarded to the blockchain but how do you get them to input data into the blockchain and uh i can you know the uh you can drill down a little bit more into that but uh the question is for virile and i think that this whole platform that you are seeing demoed now is working on a concept of it's a web-based application of course

95. 46:37

    and it connects via rest apis um you know to the underlying blockchain ledger if you've been configured as a party on that so even if you're not don't have a physical node on it you could be configured as a party and you could be accessing accessing it uh you know as a party on the on the network even though you don't actually know it so i think that could be that's one of the easiest ways to get people who don't want to install a blockchain

96. 47:02

    you know stuff and you know set up a network or be you know manage a network an easy way for participants to be on board on the network go ahead okay sorry yeah so as earlier manisha was touching upon this regulators may not have to be external parties they can be their internal organizations also who are handling uh this compliance and the regulatory needs so that's where within the network they can be onboarded or it can be as well a separate network if it is a

97. 47:38

    external party so once the regulator has authorized this trial again the sponsor is next going to share this with the cro for feasibility assessment so once the sponsor has come here he is able to see this pharma clinical trial that has been initiated has been approved and authorized so next he is going to invite the cros and because cross are already on boarded now he is going to propose to start this clinical trial process

98. 48:16

    and he can onboard any number of cross who are onboarded into this platform and primarily he primarily give a id for this whole clinical trial process so we can say for example give a particular id just to identify this whole transaction in the background we can see different transactions getting registered and the ledger getting updated with this whole process next we can login as a cro go here and he will be able to

99. 48:54

    do the feasibility assessment and give his approval to conduct the clinical trial process so he primarily represents uh with his authorization to go ahead with this visibility and he will be able to next invite the coordinator once again the sponsor primarily ensures ensures and primarily looks into the proposed trials that has been accepted sorry i think the cro needs to primarily do this

100. 49:33

     next step of authorizing this clinical trial so we can see a various different process that is being there and he can invite the coordinator to conduct uh the next so we can we are seeing how multiple different parties are being uh coordinated uh uh together into this uh platform and uh all uh are giving different uh kind of permission levels to modify a certain information and what information

101. 50:03

     is being seen by different parties are not visible to every different party that is involved in this transaction which is ensuring the data pro second data protection as well and at the same time maintaining that visibility aspect so once the cro has approved and he has invited the coordinator next the coordinator uh would uh get onboarded and uh he would uh primarily see okay i think uh i missed one part so while you're doing that lakshmi uh there's another question from viral

102. 50:42

     says uh that feels like an app and this is shared between different participants with permission controls what advantages does blockchain bring to this so i think that's the that's the fundamental difference you know uh like with payments um if you if you're following all the innovations that are happening in the payment space you know ultimately the idea is that the rails the actual payments are going to

103. 51:05

     fade in the background with customer experience taking the front end even though the entire infrastructure in the back end is going to be operated differently the customers and consumers are not going to feel any different so i think that's exactly that here even though you see everybody accessing the same front end uh you know the and the uh infrastructure at the back end that is orchestrating all of this is completely different from a traditional uh from the way we

104. 51:30

     traditionally do it you know at the back back of this uh back of this front end that you're seeing there is no centralized database all of this is being coordinated across multiple different private stores which are maintained by each of these various parties um you know that are um that are accessing the system so you know while the you saw that you know the sponsor is sending an approve you know request for approval to the regulator

105. 51:56

     that uh that even though it's happening on the same front end the data is actually going from the sponsor to the regulator but everybody else on that platform the cros and the medical providers and the coordinators you know everybody else has no clue and they have no access at all no physical or logical access to that to that uh infrastructure to that to that data and i think that right now this is an interesting question about what an application is you know it's who's running that application demo can

106. 52:28

     be used to run centralized applications where the entire stack uh and and logical application is being offered by a single party demo can also be used to run fully distributed applications where there is no central party operating uh and there is no centralized data store um so it's configurable to different trust parameters and trust requirements uh which are usually non-functional requirements for a solution set um the value of blockchain would be it

107. 52:53

     is no single parties application themselves there is no single party who has access to all the information and indeed you do not depend on any single party uh for the operation of the solutions that all you need is our are two independent parties um whether that's within an enterprise or across enterprise boundaries uh to want to coordinate in this manner yeah and obviously you might need an operator so the pharma in this case

108. 53:17

     or a consortium of multiple farmers or even the regulator themselves or even a third-party cro they could be the owner operator of this network but they only have access to operate the network you know they don't have any access to the physical data or anything that else that is there's a bar a lot of different options there yeah and we can definitely explain this in a little bit more detail offline yeah so before uh yeah before we end i

109. 53:47

     just i'm just touching upon how this whole demo model uh primarily is built as a framework which is easy to implement and faster to build a solution so this is how various different parties are getting onboarded we can see primarily the genesis contract being created at the first place which initiates this whole setup so once we have this set up that's where we can start this whole clinical trial network with the various different parties so we can see the signatory we can see the

110. 54:27

     operator and we can also see how the non-consuming regulator one has to keep that contract active to ensure that he gets to operate on the end to end the life cycle of this clinical trial so we also see how different templates are on boarding different parties because clinical trial approval request which requires regulator and which requires the sponsor who needs to initiate these activities

111. 54:57

     so each different template carries different operator and regulator and the various different clinical trial process info based on which the whole permission levels get set and the ability to alter this information or update and share some of the information with other parties gets enabled yeah so thanks uh and as you can see everybody i think the um the smart contract model is simpler because obviously as you can see uh even though this looks like code if

112. 55:31

     you pay close attention you'll be able to understand every single line of code that is written here it's just primarily the business process that is being uh that is being fed into the fed into the smart contracts layer so that's i think one of the other advantages and you can get up to speed you know get to market pretty quickly with the solution and then refine it from there it doesn't have anything to do with encryption you know data storage authorization checks etc all of that is

113. 55:56

     taken care of by the underlying smart contracts runtime powered by demo um so yeah let me um so with that i think lakshmi do you have anything else to show on the demo i think at a high level i covered all the aspects but this is how i just wanted to report on the symptoms how the patient can submit the symptoms from his own facility being at home or at his convenience so if he provide some of the symptoms and the dosage

114. 56:33

     that is being taken for example say 10 grams and he is also recording when this symptom happened to him and once he has done this submit the symptoms so next the clinical trial hospital which had started this whole process it can also log in and primarily look at the symptom that has been already recorded by bob and it has to authorize before it accepts given that it has to adhere to some of the standards

115. 57:15

     once it authorizes he it can see a symptoms whatever was registered by bob at the same time even alice was also a participant in this clinical trial she can register her symptoms either coming to hospital or again at her convenience so when she has accepted the invitation next she can record her symptoms yeah and all of this information is with the provider um and obviously the way we've configured it right now is

116. 57:52

     none of this information is accessible by the cro because obviously the cross physical data store is different and the farmer's data store is different but of course if you want to share some of this information individual patient level information with the cro or the pharma that can obviously be coded into the platform or configure accordingly when he can authorize alice symptoms

117. 58:21

     and now this provides a complete visibility onto various different symptoms registered by different participants in this clinical trial which gives a consolidated view of that at the same time people who come visiting the hospital it can it allows the participants to record these symptoms as well so once all these symptoms are recorded then it can be primarily sent to the cro who who who can generate uh these reports and submit it back

118. 58:58

     in progress trial so he is able to see this and a prepared report and what you're really seeing here on the front end are the or the instantiations of what we call demo templates i see there's a question there what prevents participants from creating a contract contract forms and contract types are are defined on a per-party basis such that it would be impossible for a party to create a new style contract

119. 59:28

     without without the other party or without the operator's consent for example such that the way the parties interact are prescribed by the demo templates which of course can be updated et cetera but um it prevents and there's a variety of patterns to build in checks as well um so that uh all data transfers require for example sponsor approval uh before they can be executed and so it

120. 59:53

     becomes a multi-signature kind of contract um which before it can be executed has to have the buy-in of all the parties but that's a great question but it gets way down into the weeds and how damn temples are constructed yes and as you as you can see i think yeah the rights and obligations are automatically defined you know so while lakshmi is opera pressing these buttons on the front end and logging in as a as

121. 1:00:20

     a specific party um you know the developers and you know the system doesn't actually need to do any explicit authorization checks because all of that is done by the smart contract so it won't allow anybody other than next gen pharma in this case for example to exercise the action that lakshmi's lakshmi is taking on the webinar so that's also a big difference from the way uh traditional

122. 1:00:43

     you know traditional authorizations have been done okay um yeah i think this brings uh us to the whole entrance process okay yeah i'm closing the trial and now the sponsor can close because he has received the regulator acceptance as well yeah awesome okay great yeah and obviously this is deployed on azure but it can be deployed on any platform you know of choice um yeah and configured as required

123. 1:01:24

     so let me let me share the summary uh let me share my screen um you know the next steps obviously learn more about demo for healthcare and uh there were some excellent questions that came up on this webinar we'll probably um you know create some content around that and and get in touch with you to explain those a little bit better probably also write a blog post on that and of course

124. 1:01:48

     connect with brillo and explore the damn partnership and the demo expertise they have um you know we'll be sending you this presentation as well as this uh recording um so yeah thank you very much and uh corey any last minute any closing comments another there are many questions and this is a complex area um so thank you for the time today there are additional questions i i encourage you to reach out would love to explore um this particular case or adjacent cases across the healthcare industry with you

125. 1:02:19

     um and and thank you so much to lakshmi and our partner brillo for showing um what can be done with daniel um and so i know there are questions out there about will there be forthcoming innovations standard integrations etc we would love to explore those topics um with you and with brilliant so uh please reach out yeah thank you so much and uh thank you lakshmi any closing comments like me

126. 1:02:41

     yeah thank you so much uh everyone for being through this session and making us uh enabled with this webinar uh thanks manish and corey as well for uh showcasing this solution in your as part of their ml webinars yeah no thank you lakshmi thank you excellent excellent demo and obviously uh thank you for all the insights of the both the life sciences life cycle as well as you know the integrities of the clinical

127. 1:03:12

     trials process so um that's it folks uh hopefully uh all of you it was informative and uh helpful to all of you like i said we'll be sharing the recording we'll also make the demo available um as a you know make a demo available to you and you can obviously i'll include contact information as well and you can reach out and and then schedule one-on-one discussions if you have to thank you very much