Powering Clinical Trials with IOT and Blockchain

[Music] thank you very much well welcome everybody to to our second session i will start by by introducing uh our panelists uh first we have uh despina daliani that is a clinical research associate at honorart clinical and she's also the colleague of the e-consent and clinical trial recruitment use cases within the pharmaceutical project and also she holds a bachelor on science in biomedical science by the institute of biomedical science and she completed the masters in food and drink innovation she has published papers related to to her specialists and prior journeying honor and she has worked in gsk in the fields of microbraiology and quality insurance welcome the spinner we also have todd covergwell he's a clinical solutions lead for ucb bioscience overseeing the electronic trial master file uh todd is also leader of ucb's effort in explored implementation of blockchain technology within clinical trials and he have been working with pharmaceutical companies and cro for over 20 years as a sas programmer application manager business analytics and trial master expert welcome chad also also we have dr christina levit kabia she's our r d project manager and past dog researcher and working in the technology institute center for research and technologies in greece third she's she has a phd from a doctor medical and sciences from the aristotle university in thessaloniki and she have also a master's degree in telemedicine e-health and in economics she has plenty experience in academia in industry and our rnd facilities in several european countries and as well as running in different startups so um and finally she she's a primary research expert involving different different fields including healthcare medicine lifestyle and well-being in and including different technologies meaning ai iot and blockchain welcome also and finally uh we have uh dr giuseppe montelli he's graduating as a medical doctor at the university of pisa and he have a specialization in hygiene and public health and a phd in methodological research from the university of rome and a master of science in pediatric medicine development and and evaluations he is currently consultant at the clinical trial in the hospital bambino jesus and which is a children's specialized hospital and he works as principal investigator and over a hundred profit and non-profit pediatric clinical trials and he's a researcher in several eu funded projects and collaborates in the design of new clinical trials so as you can see we have plenty experience with our uh panelists um and to go to to to the theme i think it's important to to give a little bit of context about uh the clinical trial different process over the last year we have heard a lot of clinical trials based off the complex situation and more or less we have an idea of the sort of the outcomes of those process but but in between there is a a lot of different steps that it have to be covered and with the context of pharma ledger we we are addressing them trying to to improve them and give a uh a better solution within the context of the clinical trial so i i think is a good start to leave the floor to giuseppe as expert in in the clinical trials uh from the context of the principal investigator and being the closest one to the patients at the end is our uh the the benefits of of the result of these trials in a way so you said that please the the floor is yours thank you very much uh all of us in the last year the pandemic here has been familiar with clinical trial results of double blind placebo control control at the trials on vaccines or antiviral drugs for cov19 but clinical trials are complex things that are the main source of evidence on safety and efficacy of new therapy from many decades so it is a complex activity done most of all in high level hospital that try to have quality data about the effect of new drugs new vaccine or new therapy even diet or lifestyle intervention to people with different diseases so the object of the clinical trial is probably the most complex in nature is the human being you know and me as a physician in a structure that devotes to children can i say that children are also more complex than educated human being because of their developing nature and also the need to have relations not only between the patient and the physician but also with parents and legal guardians in such a context there is there are also psychological factors and also legal factors that have to be addressed data collected by patients are not easily verified and with the complexity of clinical trials and collection of data directly from patient let's think to ecg device that send data for 24 hours a day for more days these these collection and sending of data become very important to be verified another thing that we want to highlight in this conversation is the trust that we need to establish with parents and patients that decide to be to join a clinical trial in such a context a technology that give gives to a patient and to legal guardians or parents all the information in a trustable way and allow the patients or the parents to adjust in real time to relevant information uh ask for uh questions and decide to provide additional consent or deny additional consent for a procedure that in these dynamic process can happen it's a really a really um interesting feature and blockchain can help in this way because if we providing the right information we give to uh patients and the parents uh the reassurance that their sensitive data will be used in the right way without access to any others and their consent would be provided and verified in a trustable way it would be a very important way to go on with our activities and have a more efficient research excellent thank you very much uh well based on on on your your clear introduction to to uh to us we have two topics that we we have to highlight here one is related to the iot technology as you said that is the example of the ecg that is sending data consistently for 24 hours for instance and we have to process and be sure that that data is properly sent and and and delivered to to the rest of the process and and also we have and it's important that you highlight related to the consent and in this case the the ascent also of the children we are talking about two situations and and also the process that uh it's not it's not only the consent pre-order study but also during the process of the study this can change and we need to update those consents and so on and if i am not wrong the traditional procedure is that patients should go again and meet to the doctors and update that information is a very slow complex and um process is quite boring let's say in a in a in a simple way for patients let's say so um in this way uh and i i i opened this question uh to to despina um how we can address this with with the blockchain how does blockchain can actually improve these process related to the consent of patients and ascent of children in this in in this scenario of the clinical trials thank you for the question jose gabrielle so as uh giuseppe said then you mentioned the consent is one of the most important parts of a clinical trial it's actually the most important one without the consent nothing can start in the clinical trial and um it just to highlight how important it is it is basically and the thing that once uh you basically consent to participate in the study that's when everything starts getting compiled about you and all the processes start and everything can be continued so what they consent and what consent can do is you can basically give empowerment to the patient to par the participant in the clinical trial to decide what they want to do so if they can um which we can track what's happening in near real time we can also track the processes around those participants in the trial so there are many chances that you might consent to a study and after a while something changes once they say a new procedure gets added you have to be reconsented and because there are a lot of processes involved in a clinical trial you might not immediately consent which is not good it said one good example from that that has been identified from the annual reports from the regulatory authorities is that over 50 of processes and are inadequate to ensure the clinical trials quality and over uh fifty percent of those um identify that clinical trial records are inaccurate usually and this happens because everything around a consent is um it's difficult to track it there are so many things happening around this that's why we need to fix this because in the end we have approximately five to ten percent of uh problems found in compliance and uh with the clinical trial protocol and to have everybody who doesn't know what a clinical trial protocol is it's basically an instruction manual or how to do the clinical trial what happens usually with all this process uh when you basically are not 100 compliant is that you have cellulite information and there is less transparency then you can see that the inspections are happening later on they are limited to the post-compliant non-compliance and this is a very inefficient and very complex system and as giuseppe said the data cleaning everything is happening in a slower rate than it should so what blockchain can do is it can add a lot of values in this because we will be able to trace everything and at the same time we will have no siloed information when there is something transferred from one actor to the other actor which is a very important thing also it adds trust and it's really important that we have compliance as well because the most important thing for the clinical trial for everybody is the patient's safety and that also that their data is secure so by adding a system like blockchain to make sure that the patient everything happens near real time and everything is addressed near real time any changes are immediately taken on board and at the same time we know that the patient has been empowered to basically decide what they want to do with their data is really important it can really help and i hope i have answered the question in one way would anybody else like to add something else in this as far as the consent goes i agree that's one of the most important parts of the clinical trial and actually for the uh for the patient itself to consent to to participate i want to go back to at least what giuseppe was mentioning about the the data collection with these devices and for us from a pharmaceutical perspective um if we actually have let's say multiple sites you know let's say giuseppe is just one site and we're collecting information from from him we actually are working with multiple sites multiple countries from a pharmaceutical perspective and for us to be able to collect that device data and process that quicker or actually as you mentioned just being about the safety of the patients we want to make sure that if there's something that's coming up in one of our studies that we react quickly and make sure that we we address that so we see that the devices themselves pulling that information in coming up with some smart alerts that we may put right in blockchain that would send it out directly to maybe not only the patient maybe not only the caregiver maybe to the the principal investigator uh and and maybe uh you know if if there's anybody else that we need to notify you know we can go ahead and do that really quickly if i also can step in i think it's very important to actually mention the iot and the combination iot plus blockchain because the blockchain is actually joseph mentioned and it's mentioned by many people all around i think who uh studied a little bit blockchain just you know some basics would associate with chain with a trust so it's something that gives a trust so uh with the iot uh that's um a lack of the trust that we can see you know in the pool of the research and in a clinical trials as well so the blockchain actually brings this kind of uh module or aspect that uh can change the game dramatically to the benefits of all the parties involved so yeah i i would say that um the combination the hybrid solution of the blockchain adapting the blockchain in the iot would be a crucial um support of the clinical um clinical trials and i actually also wanted to link that when we talk about a clinical trial it's not only the you know trial itself and and the devices also involved not only the you know the um collecting the data and then the data management but also we talked about the supply chain so uh for example for the clinical trial we will talk mostly not about only iot but iomt which is the internet of uh medical things right but for the supply chain we would talk about exactly iot different sensors that would allow actually the um transparency of um handling their products you know on the way to the delivery and if something was violated or not uh for example the temperature excursion or the humidity or maybe the products uh you know the drugs were uh handled not care um with their yeah little care so i think that you know the it uh from brings um while you not only you know the patient who is participating in the trial within the trial yes starting of course from the content but also actually increasing the safety if we consider the use of drugs i definitely with what you're saying christina may also add that then from from sierra's perspective clinical research organization this system is extremely important because that way we can have confidence in everything that we have that we are using the most current documentation because basically when you're participating in a clinical trial there are sometimes most of the times actually changes that happen for the actual study so you need to always make sure that everybody is updated with the latest version for example of the consent document for the participant and the blockchain could really leverage this because we could make sure that we're using the most current documentation in all these associated places and at the same time we will be able to manage this process because sometimes different clinical sides the clinical sites are the places where the study takes place like where giuseppe is at so we make sure that they are using the most current version for those specific places as well and everything is dealt real time so there are not many protocol deviations which we are trying to avoid avoid at the same time from a serial perspective which i am it's also adding the advantage that we have reduced time to verify the data because it will be easier to make sure that nobody would actually try to um alter in a fraudulent way the system which is extremely important as well and this increases the patient's safety and at the same time in times like this with covet 19 ongoing we can this can assist the remote work which is can which cannot happen in sometimes uh when there are situations like this and you cannot go to the site when to verify the information so you have to wait which obviously it's causing some further protocol deviations and issues i think actually the pandemic that is happening right now brings um maybe a need of digitalizing the processes that were um that were not before so i think it's uh you know they're pushing the whole industry reconsidering how uh then you know that not only the data can be managed but the whole processes could be improved yeah yeah i know we also have talked about putting at least the device management into blockchain as well so at least when you're assigning a device you're putting that information out there when that device is let's say retired or another device is assigned to that same patient all that information can be tracked in our blockchain same thing is as if there's any particular version maybe that's on the device we don't want to have the device version changing throughout the clinical study or if it does then we want to make sure that we know when that actually changed so having that information in blockchain easily accessible and non-modifiable is something that we actually are looking forward to as well i agree i may also extend to the fact that this whole blockchain system can also assist in other areas of the clinical trial for example the clinical supply where you have the product where it's get manufactured to the point that it actually gets to the participant it is really important because you there are many different people usually involved in those processes so it is very difficult for different systems to unite or when they unite or they try to collaborate at least this is causing again solid information so some things are actually not transferred the same way as it should which is making things unnecessarily complicated and it's removing some really important credentials and obviously trust and audit is more difficult to achieve this way yes if i can add something a blockchain can improve clinical trial process both from patient point of view and researcher and cro and the sponsor but we have not mentioned the regulatory agency so we have seen in uh 10 months developing a new effective vaccine for kovi 19 the process were the same we have had phase one two and three uh studies but in these contexts uh the fda and the european medicine agency have reached to verify all the data in such a short time using this technology using blockchain and allowing the regulatory agency to access to the data in a regular matter and in a trustable matter will help to have a short time in a shorter time effective medicine not only for kobe 19 but for any other disease so this is really important we have uh understood he is in in a global emergency but we need to take home the lesson and try to have effective and safe vaccine and medicine using uh tools provided by technology in a shorter time if i may uh jump in i think that right now we are talking um all of us would agree on a lot of different use cases that could be um found in the you know you know in the applicability to the clinical trials to the processes around the clinical trial and of course we talk about the blockchain plus iot right so i think that it's um actually posing and a hybrid solution which is of course different to just you know play an application of either blockchain uh or iot and i think that um so we would align of course on lots of hopes that we have towards this hybrid solution but i think it's also very important to understand the challenges that uh it brings so for example as um jose gabriel mentioned before uh the iit is a field that no one is questioning what it is everyone knows iot that's internet of things and what is the you know application basically we cannot imagine our life right now without ig it's it's uh i think it will stay with us forever right the blockchain is um uh of course it's a new technology and um which means of course it brings a lot of value already a lot of hope of course um it promises many things around the trust and security and privacy there are many uh terminology data transparency that are actually uh related or associated with a blockchain but um when and actually to mention that both steal even those processes i mean the iot is more let's say established compared to blockchain both of their fields they poses their challenges um but we are dealing not only with their blockchain or ideas was mentioned but combination and that combination actually um discovers the new uh directions of the challenges or issues or problems to be solved i can i think name a few of them just to give let's say an example so when we talk about adopting blockchain in the iot um there is a processing issue that might come when i say processing it's you know the blockchain is a resource-hungry uh technology yeah so for example the mining process and the complex crypto cryptography that come in on the background it takes a lot of you know energy and you know that's i think that's obviously for all the people um involved in the research and development and um on the other hand when we talk about um iont internet of medical devices you know the trend goes towards a small devices wearables uh you know uh smart bands some small devices that will not affect our life right so and that you can see it's kind of that combination of them um of these two technologies poses the the challenge towards uh the battery actually and the energy limitation and the storage yeah because again when they you know any phone any device go smaller they cut their battery they're trying to actually um invent some new um processes or technologies but still it's kind of the storage and the energy uh that the batteries uh they're demanding yeah and then we link this to the storage which actually for the iot devices that are happening in the that are used in the clinical trials they uh process a huge amount of data so we talk about a really large large large flow of data and these data of course should be um treated and stored either in blockchain or other solutions and so we have that the story challenge but i think that um to the audience to give a little bit of the background as we are from the pharma ledger project we're working on this project um we are working on the off-chain solution so we opened the issue that senior our coordinator mentioned earlier and i think that it's kind of you know um also linking the challenges of um lack of technical details around the world so when i started just turn the project and i started to study you know what's what's around this area i found that the resolutions but you know so little technical details and of course i understand that the market and the competition and people try to you know to do their own work in their way but on the other hand you know that lacks of the faster growth and development of the technology and i think that it's um you know from the perspective of pharma ledger we are doing some significant work because the project will uh disseminate the result and that will be um able to be reduced uh to you know to uh in the other uh either products or research and development products or solutions so that's to be mentioned i can go one with the challenges it's just like uh guys stepping and we can continue on the challenges if you're interested yeah at least from the pharmaceutical perspective you know uh coming up with the the api to pull information from those devices you know it's great to be part of pharma ledger where we actually can can cover that through through multiple pharmaceutical companies you know multiple sites um and cros as well trying to figure out what device companies um let's say let's say allow us to go ahead and create an api to pull that information directly from let's say their secure cloud or their secure database into our secure area to be able to go ahead and like you were saying christina is either put that in blockchain if that's where it's required or put it into our dsus and and have that in a secure location so i i think in this type of an environment we'll be able to go ahead and make that list of devices that we have apis a much larger list than we would if we were actually working independently on the same task yes indeed and i think that that's just not um it's just not possible to put all the data on the on the you know on the ledger because that's an enormous amount of data and you know the ledger um is i think generals tend to be used for um and let's say stealing the particular deals yes originally yes it's let's say coming from the finance direction yes it's the ledger it's uh from the accounting so yeah and then when we i think that we need to kind of balance on you know use of the blockchain and balance it with the other solutions um available for example iot then we're coming to the cloud computing and so on and of course there is a huge need for the off-chain solutions because this is the only way absolutely all right thank you uh well just just to jump in uh we have received just some some questions already for for the audience so i think it will be interesting the because complement part of the discussion that we have so far so uh one of them is related to directly to to energy consumption for instance one that i see that's quite interesting um and the question is uh energy well it's more than uncommon but i think will be interesting for for you to to complement this says that energy consumption of dlt can be optimized up in the use case and should not be a problem uh that that's a proportion of proposals for this but i think it's quite important to understand also that we are dealing with a lot of data that is being processed full time and in some of the cases depending on the scenario we we have to deal with real-time processing and and sending data so that that process of energy consumption is something that has to be addressed quite well and and another thing that is i think is interesting to to to comment i mean i if i am not wrong it's one of the things that especially todd is is dealing with is related to to the data silos uh one of the things that and it was commented before already is that we are dealing with a lot of data that needs to be analyzed and processed and and different components related to the clinical trial have access to that but then part of that data that can be quite important to to use is is um is lost and we cannot and we cannot use it in a better shape so i think i can i can open the here to talk in order to give us more context related to that of the data silos and how your ambition to using blockchain and the advantage that iot also give us to the process because it's now more data that we have to manage now using these technologies yeah thank you um yeah i i guess looking at a larger vision you know you know e-consent is one of the first things that we work through and then once we have that then that maybe opens up the the data sharing units that we actually have collected all that data so we're breaking down those silos because in the past or let's say currently we are still collecting device information maybe lab information and that information is then added into the clinical study later on in the process so if we can actually break down that silo and have the data coming in at the same time we're actually collecting the case report form information and that can be joined together so it's uh it gives you a more holistic view you don't have those data silos where you have those data transfers late in the process and then you have to do all the reconciliation and the cleaning part of it and then in addition you're you're trying to make sure that everything is is uh resolved before you're actually wrapping up the the clinical study and closing out the sites the other view that i would would say that we have is is what we can do is is prepare for us to be ready for personalized medicine as well so outside of the clinical studies if we actually have patients let's say consenting to open up their electronic health record and and then let patients be discovered that way we can go ahead and recruit patients faster for clinical studies getting those clinical studies run a bit faster that way and completed and then if they're still consenting in that process then bring in real world evidence or real-world data to go ahead and allow them to let's say or their physicians to offer suggestions on maybe a alternate treatments or other methods that may improve their health and whether they're you know eating a certain way or or if there's a particular new uh treatment that's available that would match up to that patient then that would be another way that the the data silos being broken down would actually allow them to uh to have that personalized medicine approach i think what actually just highlighted is the complexity and the need of all the potential use cases to be in the synergy right so when we talk about uh just uh let's say clinical supply or just uh supply chain in the in the pharma industry it's it will be always linked to the patients somehow right and then we talk about how it is linked and then it links to another use case so i think yeah when we work also on the solutions that um let's say um there is a manufacturing process of drugs there is a process of a clinical trial and you know for the data management personalized health which is kind of service that is running after the clinical trial finished yeah let's assume there is clinical trial about actually um um discovering either the service should be you know somehow established in the hospital like telemedicine service or not so we talk about the whole complex picture of the health care which involves uh probably most of the stakeholders in the field of pharma and healthcare that's true and it's also adding another advantage as well to this whole system because um with the clinical trial recruitment as well where we have a big problem with the meeting the recruitment timeline so basically slowing down potential things that could be advantageous to people for their treatments we can have the advantage now to empower patients to search themselves for something that they would like to participate during a clinical trial and at the same time choose which one they would like to participate as well which is going to be an advantage instead of basically at them trying themselves to find a clinical trial or everything being slowed down because we don't have them we haven't managed to meet the timelines for the recruitment yeah guys you know the more we talk the more i believe that it's very truly combined you know the all the benefits that the potential solutions can bring and all the challenges that of course will have to be addressed by technical people otherwise even liking one of the aspects and um there are quite many uh vulnerable aspects when we uh talk about a medical field about drugs about health data mainly so yeah i think that you know then my message would be that people working in this field should of course focus on how to uh to solve those problems in a most efficient way of course and i think that i want to emphasize them uh collaboration of efforts as i mentioned previously there is lack of you know technical details and i think yeah that would be beneficial for the research results and you know anything that is um becoming a product before was research and development so i think that it's crucial you know to share these lessons learned through the the whole industry otherwise you know the people will kind of run the same circles maybe that would be slightly different but still and another point that i think i want to bring is that actually uh lack of standards so we already agreed that we are dealing not only with the iot or blockchain but a combo and i think earlier it was mentioned by our coordinator xenia that you know we are looking for um agnostic solution in the pharma ledger and i think that you know the uh the main benefit of this agnostic solution uh would be um actually it will kind of um govern them interaction between iomt medical uh internet medical things uh blockchain their you know um artificial intelligence processing or cloud computing that's all because you know we are talking about so many other technologies that need to be uh involved to support the processes but the technology that the core technology should be then agnostic the plot the platform or infrastructure otherwise you know i think that people who are working in their health care uh they would or work for the industry you know and they know the problems of uh actually uh interpretability of the data and integration integration of different systems i think that it's it's a a pain of all the people regardless you know um regardless country regardless anything uh platforms that will be always a problem and i think that um you know the standardization bodies should get also kind of on speed and to have a multi-disciplinary uh team on board to kind of support the processes yeah to ensure that that's yeah that's a very important issue and i i was going to highlight just to comment and thank you for for starting the that that comment uh at the end one of the things with the with iot technologies at the end the providers works uh traditionally by themselves let's say they have her they're close solution and it's quite complex to access to their their technology and and they are trying in a way to not share their their solutions that's the traditional way let's say of iot technology and and this is a quite important challenge that uh that has to be addressed in order to improve even more the uh the the scenarios that are trying to to deal with and and i opened the floor here also to um to to ucb as uh and especially as a technologist in in the pharma for pharmaceutical companies how how how do you see to to address these challenges uh in a way that we can uh integrate different type of of iot technology for different different type of brands that they're trying to to stick to to their know-how let's say how we can challenge that yeah that's a good question i'm glad we do actually have our uh technical experts in the uh the pharma ledger as well because uh you know in the pharma industry we do try to have everything you know standardized but again every company is going to have something different and if you actually acquire another company they're going to have their own standards so you have to adopt either one standard the other or convert so we have to figure that out but you know at least when we were talking about the iot providers we were talking about bringing that information into our dsu's and we've been discussing at least the da dsu's that are let's say schema-less so you can bring in that data just by telling it what columns you're bringing in and then you don't have to have all the columns when you're designing that dsu so and my point of view not super technical about it it looks like we'll be able to handle those differences between the the providers when the data is actually allowed to flow through those apis into our dsus and maybe christina maybe you actually can talk a little bit more about the technical aspect of it because i know that we've at least come up with the ideas on how we're going to be able to store that i started to speak on mute sorry about that it's a common problem and i think that generally speaking we highlighted already the need for the open um or the need for the off-chain solution which for us it will be open asu and opendsu is um a development but which is growing of course we are contributing to this and i think there are many uh applications to that so i think that the most um crucial to understand and i hope that actually i mean um i don't want to bring any drama but i would like to express that you know sometimes people say that we can use like smart contracts and that's kind of everywhere considered being a saver yeah a smart contract something um automates the process that that is needed but from the perspective of patient actually it gives a lot of uh vulnerability and i think that um the point i'm not sure if i'm answering or not but the point i wanted to bring um not to forget that when we talk about um um solutions and how the data will be stored and how the data will be passed i think all of us agree that the terms that are used it's um a privacy security confidentiality um anonymization but then you know they are interchangeably used which um sometimes it's um it's um might not be actually the you know the right the same meaning of all the words i think it's important to understand when we talk about any technical solution what exactly we want to give to the patient for example um actually um the confidentiality is the one that gives uh the you know them power to decide or to control now what data you know to be used um and by who so you know in i think that that's one of the use cases we say that we want to empower patients you know to participate in general you know to to give this feeling not only the trust but control over the you know the data and then we say that it's it's private private but then it's about confidentiality not the privacy you know the privacy is about actually um the the right to give the data to keep the data for themselves but as we already identified the data will go somewhere yeah and of course it depends and i think that it's still in the discovery for the pharma ledger by each of this use case uh exactly who is the owner yes who is creating those issues and so they see you to the to give some uh details to the audience it's a data sharing units so it's off-chain solution that gives a flexibility of the management actually of this uh i would say sharing the access to particular pieces of data and as i i'm also participating in the design in these types and working on one of the use cases i can say that it's very flexible which of course any technical people will like yeah do you see there are there any any other major technical challenges in the development of those solutions that we want to achieve and uh to be honest i i think that there are actually as i mentioned before uh my personal opinion you know the more as you know aristotle said one time and i i it's one of my favorite phrases the more you uh you know the more you don't know yeah so the more you discover issues to be sold the more you uh the more you discover the things that actually untouched at the moment and needs to you know the attention to be brought to those things i think that um destiny depends on the exam on the use case and i mean not use case that the clinical trial we're talking about but even inside of the clinical trial the iot could be used differently right so i think that it depends i listed already some of you know the uh the processing the storage um i would say um more about the mobility i mean that's all actually linked so the challenge would be the mobility so what i mean here is that you know the blockchain as it is um designed let's say for a fixed network topology but when the person has a variable or i don't know some device monitoring uh some vitals uh that is actually you know uh kind of an event of continuous uh change of the topology which is a challenge to to my to my belief and also when we talk about imt we talk about them real time data so it's um you know sometimes even a second and i think that all of us agree who especially have experience in the clinical trials and um not only clinical trials but you know um uh worked with the services that are provided to patients where even one second even less than that could cause you know or could cost a life of a person or you know some abilities not to be lost let's say so in that way i think there will be challenge of actually you know uh processing them or the time that will be needed for them for the processing for example for blocks creation it takes some time yeah i'm not sure um about the synchronization of things so that would be that would be also um the key to discover but i think that you know also even in the formal lecture we work on something that we uh of course give a promise to to become a final product i believe also for us um and we have 29 partners on board for us it also gives a great um experience a great opportunity to kind of join see different perspectives and maybe come up to something that it's more of a value you know because as we say sometimes two hats is better than one well 29 is probably better than two well it's sometimes probably not so easy to find this uh you know consensus but i think that generally it works and i think that those challenges with the solution that we're working on we might not solve all of them and and that's absolutely fine that's that's normal thing the most important that we are actually doing that uh and i think uh once again i want to highlight that there are not so many um activities you know especially um open activities towards this direction the hybrid of a blockchain class iot so i think yeah thank you for the question has been thank you as well for the answer christina i i may also add that one i think one small challenge well not small challenge but one challenge that is not technical it's the fact that we might have people like regulators or sponsors or some other actors that might not want to take this new technology they consider it as a risk because they don't know about this i think that is also one challenge that might we might have to face at some point especially when it is a quite a rather new technology for the clinical trials and health sector mainly not bitcoin for example and uh we also have people that are quite resistant to change but i think once we surpass this issue it will show the value that we can add i think it's a brilliant point actually desperately brought its adoption of the technology it's indeed that's another challenge that you know that will be faced for sure but yeah brilliant thank you yes i agree with espionage sure regulatory agency are more keen to have a conservative approach so to be accepted the new technology we have to well communicate and what we are doing in this eu funded project is just this test is technology and offered the advantage to the stakeholders i think that also i agree with christine about the challenge of address well the privacy and confidentiality not only for a legal point of view but also and and this is a complex scenario since in eu we have recently have the gdpr that was not enough uh well understand understood in uh by uh both uh investigators and uh participants uh we have uh the challenge ahead to show this technology as an help for the patient to take control of their own data and this is not an easy task since this is a new technology it's not easy to show it by um in common to common people without competence uh and so we we will have this challenge ahead that's that's totally right uh todd do you want to comment something else sure well at least from the sponsors perspective we actually don't want to burden the sites with you know these new technologies that maybe don't add value but that's what we were looking for is you know like giuseppe said you know we they're more conservative conservative we're probably even more conservative being a sponsor that we want to go ahead and make sure that what we're going to suggest or what we're going to roll out and put in our protocol is something that the the sites are really going to want to to work with and make their lives easier so that's what we actually consider from our side excellent uh well we only have uh three minutes before closing closing the session so um first of all thank you all for for joining and and give give us your your vision of all this process and i would like just in 30 seconds if you want to please give a final statement from your point different point of view more more than welcome so so we can have uh close the session so i think i i will start with the same flow as the beginning i will open the floor to giuseppe to give us a final uh final comment we have only three minutes left so 30 seconds each and we close the session okay just um say that this project has joined a different point of view from a clinician from sponsor for cro from engineer a physician and also patient so i think that this way to put all together uh speaking uh providing their different point of view is the right one i hope that uh companies will take over their and they are showing it their interest in not collaborating and we are seeing a good collaboration between companies and i think that it is the right way to go on thank you despina so i agree basically this is going to be this whole system and there are some challenges that we'll have to face as we are developing this but there is a lot of potential and since our aim is to put the patient first and this is going to provide a really enormous advantageous aspect to this whole system so that we can ensure their safety up to the nearest detail as much as we can so i'm looking forward to how this whole project develops to go thank you you see now thank you very much first of all i would like to thank all the panelists because i think it was a really great discussion with a lot of different opinions and i think that my message would be you know the competition maybe is a force for driving the progress but i think that at this stage we need synergy and when i say we it's all people involved in somehow you know not only in pharma ledger of course but then i'm talking right now to the audience right who are doing research research development of products either for the from the side of the pharma business or you know the technical companies so i believe in synergy synergy of you know the technologies use cases the stakeholders and uh the most importantly i believe here in the balance between uh the business industry people and the technology people i think we reached the moment where you know um combining the efforts you know being equal and combining the efforts here we would achieve much more uh than um either alone or in this balance you know the uh level of the communication and um collaboration thank you thank you todd please yep i'm definitely excited we're getting closer and closer to that proof of concept that we're gonna bring all this together and be able to go ahead and display that so i'm looking forward to that that's right around the corner so uh hopefully we'll be able to announce something soon awesome well thank you very much to all thank you victoria for for sending up all the session to all of us and thank you for to the audience i hope you enjoy the the rest of of of the day with the very interesting sessions that we are going to have have a good evening thank you