Driving Speed with Digital Clinical Transformation

Driving Speed with Digital Clinical Transformation

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all right hello and welcome to another mathematic webinar my name is Nicole Owens I'm the director of marketing Communications for mathematic today we have an awesome webinar brought To Us by Viva Medtech driving speed with digital clinical transformation before we jump into the conversation today I do just have a couple housekeeping notes to share uh this webinar is being recorded So anyone who registered for it will receive it after the fact along with any slides that are referenced today and we are going to have ample time for Q a so please make sure to feed in your questions in the Q a function at the bottom of the screen and we will make sure to take those all right without further Ado I am pleased to turn over the conversation to John acampado he is the director of clinical strategy at Viva med tech and he's going to be leading the conversation today John thanks Nicole uh hi everyone and thank you for joining the webinar and thank you to uh mathematic I look forward to a very engaging discussion today with Jason and Nikki while introduce in a second as well as with your audience in the form of q a towards the end of the session as Nicole just mentioned uh before we jump right into it I just wanted to have a few slides to help set the stage as soon as I can find the slides share screen you'd think after a few years of using Zoom this would be automatic but still we go uh before I jump into it I want to invite everyone on the call to participate in the First Med Tech Medical Benchmark survey uh we want to gather the perspectives of the med tech industry on current challenges that you're facing and on how you're conducting clinical trials and how we can assess your future needs and opportunities to enable digital transformation to run those digital trials there's a QR code still right here on the screen and then after this webinar uh we'll also send out a link out to everyone that has attended or registered for the webinar So speaking about digital transformation decentralized clinical models electronic informed consent electronic clinical outcomes estimates and other clinical Technologies are becoming much more accepted and encouraged by the FDA more med tech companies are making the shift to digital approaches and for this webinar we're going to have a really robust discussion without turumo is making that ship as well as the approaches and best practices that they've implemented along the way as Nicole mentioned I'm John acumpado the moderator for this webinar and I'm the director of clinical strategy for Viva med tech I've spent more than 17 years in the Life Sciences industry working in clinical data management programming clinical operations and software development as a former Viva customer myself I've always been amazed that viva's dedication to the product that its customers use as well as the community that it brings together joining me today from turumo is Jason Parcell he leads clinical data management strategic and operational activities at Truman Medical Corporation one of the world's leading manufacturers in medical devices and supplies tirumo and Viva recently partnered to complete a global implementation of vivid me TMF and ctms Jason also brings 17 years of experience working in clinical data management both in pharmaceutical and medical devices with a background in industrial psychology he is quality driven and leverages his experience and passion utilizing diverse strategic approaches processes and Technologies to identify and Implement Business Solutions supporting the quality and integrity of clinical data and data management activities also joining us is Nikki Feist Nikki is a principal business consultant for Aviva Medtech business Consulting and she brings over 20 years of experience leading cross-functional strategies in the medical device industry as both an industry leader and consultant her Focus has been on clinical research strategy and operations with demonstrated success leading complex initiatives she specializes currently in process harmonization and Improvement change management operating model design and go to market strategies more specifically she has expertise in clinical trial strategy and clinical operations digital transformation and optimization I'm going to go ahead and stop sharing my screen and then I will ask Jason and Nikki to go off you and join me okay thank you John thank you how you guys doing today pretty good A little chilly a little chilly yeah I am coming from uh Oakland uh or Alameda right now and it is a lot colder than San Diego so uh I I can't imagine it can be well I can't imagine it could be colder but hopefully not too much colder so all right uh let's go ahead and kick it off uh maybe the first question uh to you uh Jason to help set the stage uh can you give the audience an overview of termo's previous platforms highlighting any inefficiencies with those uh various systems and they keep uh feel free to feel free to chime in based on your experience as well yeah so tarimo came from a very heavily outsourced model so I was brought into trumo medical a year ago actually to start that internalization process with data Management Services a little bit earlier we had started the same with our operational model so we were really working with various cro partners and leveraging the various systems that those Partners used so we really didn't have a lot of internal systems for ctms etmf um and and those critical operational systems that that you need to run clinical trials um so with that came a lot of manual tracking so I think a lot of us have been through the situation where you know you Outsource and you start getting pieces of information and and you start manually tracking that information typically in Excel which everyone knows and and loves um but that also lends itself to a high potential for error right so you're taking something from one source and manually entering it into another source uh and really increasing um the opportunity for error there uh so the other aspect that we had you know we just we have a lot of insight or visibility to the day-to-day activities when you're Outsourcing a number of of clinical trials especially when you're leveraging different vendors for those trials um you know just not having the insight into the day-to-day activities and the systems and the functionalities of how everything was running um kind of led us to a lack of audit Trail on documents too so when you're getting into etmf and other documentation you're trying to track things manually in documents like Excel they don't have an audit Trail associated with it so and kind of lose that audit history of who edited what who had done what in the document especially if you know an error occurs or something like that it's hard to figure out when that happened and how to you know course correct um so as you can imagine with all of that and our different partners different vendors manual tracking all of our systems were disconnected right so so we didn't have that etmf to ctms connection or EDC to ctms connection either um so really kind of disconnected systems coming into you know from a vendor to the sponsor into manual tracking um you know no set filing structure outside of our sponsor files at Terumo so really just a whole number of um of issues in my mind and inefficiencies that that you see when when you look at that model compared to where we're trying to go now yeah absolutely and you know you and I have been in very similar shoes uh I I can empathize with you a lot of different disconnected systems uh in my previous life before I joined Viva definitely so yeah I can I can definitely align with what you're saying right now uh Nikki anything to add on your end no I I think it's um just kind of echoing that the manual process I remember you know being on the the industry side and the sponsor side of having maybe 10 different worksheets or spreadsheets that we were working from and tracking various aspects of a clinical study um and just how manual that process was how time consuming it was and then also the lack of visibility as the leader in the organization as well when you have all these manual spreadsheets which are not harmonized between the different clinical studies as well um just how difficult that is to have this ability to the overall clinical operations yeah yeah uh Jason if you could go into a little bit about what's what's the current vision for Terumo now like what what is driving that clinical digital transformation I'm sure a lot of us in the industry are are extremely familiar by this at this point now with umdr where there's other specific regulatory aspects that you were hoping to address with this change to really help drive your organization forward yeah great question so really that that driver um was driven by um a concept from our our corporate division of of one Terumo um so really kind of pushing this one turumo uh Vision so to take a a step back from that um you know we had a number of entities or divisions running our clinical operations and operating kind of separately so really kind of looking to you know how are we going to digitalize and bring all of that together um so the process started back in 2018 where it was a nice to have a digital platform and it really became a must to have with kovid right the whole landscape changed of how we operate um you know you couldn't walk across the the office and have somebody hand sign or wedding sign something anymore uh you know we're all working remotely now so really kind of push the digitalization there um and and with that we really wanted to improve our clinical trial operations and efficiencies giving us that increased level of visibility oversight better control over you know operations and documents and really John to your point the ease of meeting Global regulatory requirements so we're a large Global med tech organization and you know we get into different regulatory authorities like eumdr FDA pmda you know Health Canada you have a number of different bodies that you're dealing with and really wanting to find a centralized digitalized solution that was able to support all of those different regulatory requirements along with making our operational processes and the way that we're functioning a lot more efficient yeah really really great points could you go into a little bit of details I'm going to just hold on one friend that you mentioned that with terminal being a global organization and a large entity how many current business units do you guys are divisions that you guys currently have within within that larger group yeah so there's a large number of business users or entities within that but there's really six that that run the clinical operations or clinical trials um so so those six entities are all you know kind of being brought together by by having a centralized system like Viva um come in and and really kind of push everything to leverage a platform rather than functioning you know disparately and and kind of decentralized we've brought that model back in to centralize you know where where are uh etmf and ctmf are functioning out of um and that we're using that system consistently yeah yeah anything to add about you know some of the similar similarities that you've seen across the industry about the approach that trumo is planning to take yeah I think you know we are seeing the same themes you know Drive med tech companies to launch into the you know clinical um and digital transformation to really meet the demands of the market right and I think traditionally Medtech is uh you know very far behind um Pharma right in several years and really embracing and adopting new technology um and I feel like as the regulatory environment evolves there's such a need for companies to transform the way they work to become you know more agile more compliant um and like Terumo I think several global companies are recognizing the value of a centralized clinical operations team you know very much to drive the harmonized processes to create kind of as Jason was saying more streamlined efficient um and transparent ways of working both internally but also with your external you know clinical stakeholders right yeah and so I think you know Terumo you know in working with them in in TMC I think really understood um that in order to be more proactive and future forward they needed to find a way to re-engineer their study activities and the way they work so I think while this offered I mean Jason has been very time consuming for you guys um like you said you started in 2018 um but really allowing you guys to move from an outdated manual process to to really capturing study management data that can be predictive in nature um and I think by automating some of these processes you guys were very successful in removing some of the Redundant efforts you're reducing your failure points your enabling organizational transparency into how you're conducting your trials um your site and study data your subject management right um and I just feel that you know as um as you continue to grow and utilize the system you know become even more powerful as you learn kind of from the past studies and then plan your future ones yeah Jason I wanna I wanna uh pull out something that Nikki just mentioned uh with the Medtech industry being a few years behind it seems like with with the from the larger Life Sciences industry as a whole do you have any any thoughts there about why that could be is it perhaps the due to the lack of specific regulations about formatting a data I know you know coming from Pharma as well we had very specific rules about C disk sdtm any thoughts there which I I just picked up on what Nikki mentioned I thought that's incredibly incredibly poignant about where we are within the Medtech industry yeah absolutely um I I think it's interesting right we keep hearing about some of these regulations coming into to Med device um especially C disc is a big one right I've been hearing about it for years you know cdisk is coming um but it's not required to your point so I I think when you look at it you know that the med device industry maybe not being as as large or as focused um as Pharma was focused on previously it's kind of held it back a little bit um but I think what's nice now is there's a big boom in you know companies like Viva pushing for med tech right pushing for Med device um and you know us being able to maybe if we're not required to do something like CJ square or Dia right now we can come into alignment with those and actually leverage the benefits of it like getting our regulatory submissions in and reviewed quicker because you know we're now following formats that that the regulatory um bodies are familiar with by dealing with Pharma you know it's it's been interesting right with the industry but I really feel like it's starting to push now so there's a huge change in the med device industry coming that that's really been I think coming on slowly over the past couple years but now I think is almost in Full Throttle at this point yeah yeah absolutely I mean just just the idea that you know standardization is always fantastic right and I think a lot of us on the call will hopefully agree with that but with med tech medical device Diagnostics specifically uh it's at least for me coming over from Pharma a few years ago it's become abundantly clear that med tech it's not that everything is different things are specialized right and we have to be able to adjust as an industry to that make sure that we're you know the proverbial agile we want to be that we want to reach that mythical inspection Readiness Milestone at any given time but at the same time it's it's going to be uh our responsibilities in Industry as a whole to be able to try to get that together hopefully yeah and I I think John touching on that you know the specialized word right it really is very specialized uh when you think about the products and what these Med devices are and the different things that they do um it really is specialized treatment um you know that that kind of separates us and I think has kind of driven that lag in behind two you know of technology and digitalization because it's how do you stay on top of that you know how do you meet the requirements of that in a digitalized way um but it's nice to see that you know that industry is is changing so rapidly I mean if you think about our phones right how rapidly our phones change if I look at these systems now you know amen you know Viva right we update you guys update consistently right and those updates are made based on feedback and efficiencies and things that you're seeing uh you know previous Technologies just didn't didn't update like that uh it took years so now we're seeing this rapid change and development and it's a really great time to be a part of it yeah right um another question for you Jason if you could go into some of the the critical things that Terumo was looking for specifically as part of your decision process when you're going through and that one Terumo Vision what what was aside from the regulatory aspect that we're driving it what were you looking for uh in that digital platform yeah I mean I think again the biggest one is that the regulatory requirements but outside of that you know we we really needed a global digitalized system that could support multiple business units multiple divisions that that work in you know slightly different capacities and have different business needs but but be able to kind of Leverage that centralized global system um and you know Vivo was able to offer that with us and work with us and customize things a little bit here and there so that that we can function in that way um you know I think another big piece of that decision-making process was the level of support the partnership right so it's it's not just you know here's the system and and go and you're on your own there's really a lot of partnership and consistent meetings and communication that um you know kind of set things apart for us in our needs uh thinking about you know I know Terumo is not the only company that functions the way that we do but you know how do we make that work right with a centralized system uh and and Vivo was really there every step of the way from you know implementation support um business Consulting so the the amount of work that we did with Nikki and her team on the the Consulting side uh to really kind of help drive that that partnership and support um you know and I know Nikki we can probably dive into that that level of support as well but really just always coming and being able to discuss a question and find a solution that fits our business need was was one of the biggest drivers even in those early conversations when we were evaluating systems it really kind of Set uh Viva apart from you know other other areas that we were looking at thanks Jason great uh Nikki would you want to add anything to that last Exchange yeah I think um you know it was the the process that we went through and really trying to to understand exactly where your organization was at TMC right um and how we could come in and Consulting and provide a value beyond the technology right we have our internal Viva colleagues that support that level but how could we help you um be business ready how could we stand up your your team um for user adoption to embrace that change and so you know I think that the change management aspect of of staining your team up was very critical um and you know understanding kind of exactly where your needs were and as we got into the engagement right we recognized too that hey we you know we thought this would be something that you guys would need we quickly moved and pivoted around in the engagement to make sure we met the needs of where your team was at that point um to really adopt and Implement uh clinical at TMC in the division okay watching when when any organization and this is maybe not purposefully a loaded question but when when any organization undergoes a really big potentially multi-year change implementing systems is is really one thing but you're also going to have to transition your respective teams uh if you can give some insight what are your recommendations for change management and training for example because you know software that for some folks that's the easy part right someone will come and implement it the change ultimately is going to be a bigger challenge if you can give some insight there uh please yeah I completely agree with you whereas software is that the easy part right you have your software you you know you make that installation the implementation part yes can be a challenge um you know in the configuration but but really to your point that the change in the culture the change in the people the process that's really the the challenge um that that comes with you know taking on something like this and Nikki you had touched on it a little bit too kind of partnering with the business Consulting Group for us was a really big help and drive um to really look at our processes because coming from Outsourcing the majority of our process was focused on how do we work with it with an outsourced partner now we're insourcing and we need to kind of turn that process around and think about you know how do we write this to fit what we're going to be doing in the system um and the approach that that we had taken was to bring in business Consulting prior to TMC implementing the system so the the system was implemented in waves at turumo so we had three waves starting in Europe uh the second wave came into uh United States uh and the third wave focused on Japan so being part of that second wave we kind of took the opportunity to leverage a partnership and really think about how we want to use this system before we're actually in there you know functioning in a daily basis and I really think that helped set the Cornerstone of how we were going to operate and move forward we were lucky enough to kind of have a group of individuals at TMC that was really excited about bringing these systems in which is a unique situation when you think about change right because usually change everybody hears that word and it's oh what are we what are we doing now I need to relearn everything we've done um you know we kind of had that unique instance where things were being outsourced for the majority and and you know we have this team that's excited about this change excited about these systems coming in and we kind of got to build it from from scratch um so what we were able to do by by working early on in the process is create you know network of of change um and really leverage the knowledge and expertise from Nikki and you know hey what what is the industry doing compared to what we're thinking about and how is that gonna you know come together so we can figure out how things can can work but to your point I think that change is the hardest part um you know we we've implemented the system we're actively using the system and change is still a big part of what's going on in a daily basis when we stop and look at hey you know we're doing things this way let's look at it again and now that that we're actively using it and and make sure so really I think to your point it really is that the biggest challenge and hurdle to work through but I think realizing that you know you you have to come together and work together through it and push through that change was something our team was able to come together and focus on yeah great Nikki anything to add on your end about again some of the best practices obviously you and your group may have done with with Jason and team but you know what else are you seeing within the industry as far as like that change management approach training you know sometimes these implementations could go you'd be very quick but as quickly as four weeks could be a few months and then obviously the organizational change is something that's going to happen on a daily basis for you know a few months to come after everything's implemented yeah I think um a big thing is let's not underestimate the the value of change management right and change strategy um and I really think and as turmo um did in TMC and Jason's team you you think about change very holistically right um so again introducing the technology is just a piece of that puzzle a piece of that full equation and so um you know we take an approach of saying okay change management change strategy is about addressing the people right your team your end users your clinical Ops team as well as other stakeholders your process um your technology and the tools that you provide the team and your end users with and so you know TMC really recognized this early on as as Jason said as they considered their division um their division unit and their business Readiness Plan for implementing Vault clinical um at TMC and Jason is and his team really purposefully built a business strategy to introduce the technology as well as all the new ways of working going from an outsourced model to you know internal is a very different way of working and so really looking at kind of that re-engineering process you take a holistic approach to change management and to kind of Hit Upon what the Consulting team supported in how we supported TMC really our focus of the Consulting engagement was to establish the right framework for the team right from the very beginning um 13 had the foundation to manage they have have the foundation just you know to sustain and to continually improve on their own um so really we partnered with the team to set very clear Direction expectations um Drive accountability right there's that accountability piece that needs to be taken into account when you're embracing a new model of working return old ways right so setting that accountability um and then we really set that end-to-end support model um and really address the end user needs at every part of the journey so great great I I picked up on something both of you said so and you can keep me honest here uh today's systems it sounds like we're not designing them to actually try to tackle the same issues that we face you know in the late 90s early 2000s you know when we were moving away from paper into EDC for the first time actually starting to use these more electronic systems it sounds like the digitization that as folks are starting to understand is a bit more of a paradigm shift in terms of how folks are working less so you know that shift from paper to EDC or electronic systems uh is that something you'd agree with do you have any commentary about that because I I I find it very fascinating that you know you guys are talking about when you're talking about change management it's not just again not just the systems but definitely you're you're changing potentially people's behaviors that have been set for probably the past 20 years it's a big shift when you think it's it's a lot to take on I I think we touched on it before too with the systems consistently updating right you know that Target's always moving a little bit uh and sometimes you're ready for that and other times you're not so you're kind of chasing that that Target or you know you're pushing hey in the next change you know we really need this um so so you're kind of on both both ends of it uh but it's actually really nice um you know having that push and that consistent update and changing it it just keeps you on top of what's going on in the industry on top of the technology uh you know I can't can't walk around you know with the system that we had 20 years ago because it just it just doesn't meet the needs of the landscape anymore and that landscape is constantly changing so the technology is is changing you know right with it and a lot faster you know compared to what we've seen you know John to your point in the 90s and and 2000s that you know all of that time I think a lot of us were probably still working in paper and and web facts and all these different things like think how much change has occurred you know in the 2000s in 20 years you know that change has been phenomenal oh man step back to three years ago the changes is insane right how much it is coming and how much the industry is moving so it's it's really good so you really have to keep your focus on moving forward um you know what can I do today what do I need to do tomorrow and where are our business needs going and how do we meet those with where the industry is going um you know so it's been really interesting to say the least yeah Nikki anything to add on your end about that yeah I mean I think we all have to remember when you take this leap into you know digital transformation it's it's about the journey right it's about the ongoing process of optimizing how you're using the system um and and you know doing it periodic health checks or maturity modeling assessing assessments right and at certain business Milestones were you able to really okay are we using the system the way it is designed to be used are we using the system the way it is intended to be used where you're getting the most value out of your investment in the digital platform right and so I think that is key and and Jason part of what we did with your with the TMC team is really set that Foundation through a governance structure where you have roles and responsibilities too of saying okay you know you're you're continually lessons learn you're optimized and you're doing best practices you're continually improving as you're in the system and you're using you become mature then you do another assessment okay where else can we go with this how can we invest optimize what we're doing and I think having that Foundation that structure from the beginning of embracing digital you know technology as you guys as you go through um and just making sure that you are continually optimizing your processes within the application but also outside foreign Jason let's start the pivot now thinking about the future like what's next for promo what what else is your group not maybe not just criminal Medical but Juma as a whole what else are you guys looking for to complete that that transformation and to Nikki's Point how to maximize value uh uh you know to the most I think part of it is really pushing on that one to remove Vision right that Global Network we talked about um and how do we do that so we need to expand and build Upon Our etmf and ctmf Foundation that that we have now so we we set that foundation and now we need to build out from that you know what what is our house going to look like essentially um so looking at you know other areas that that the platform actually allows um getting into I know there's been a lot of talk about payments um e-consent uh training these are all things that you know we look at now that we were operating and it kind of Sparks you know you talk about it in a meeting and it Sparks the interest of the team globally you know hey hey that's an issue for us in you know this location well hey it's an issue for us here too so how do we you know leverage um these systems and how do we digitalize and get on top of that to increase our quality you know decrease the error rate and really kind of stay on top of that and drive um you know where we're going um you know I think being uncomfortable right so being comfortable with being uncomfortable is is a big part of where we want to go in the future right because we you know we can't can't sit where we're at today and and live there forever like we did 20 years ago right we we need to think about that vision and drive towards it and creating that one Terumo Global Network around centralized systems to really drive those efficiencies yeah maybe and just to pick up on what you said it definitely starts with having a foundation right knowing where your all your regulatory documents are knowing what you're where you know how you're going to monitor making sure everything is is in one system you know the the very uh the very elusive single source of truth that we've been hunting for for the past 20 plus years uh if we can get to that it sounds like then you can start to stack more components onto that that Foundation like you said training how to handle safe payments better how to handle um you know engaging your patients better e consent ipro that type of stuff yeah okay um all right so we're at uh about uh 1 38 eastern time as we start to get ready for some q a uh one last question for me for for the both of you um Nikki if you can go first and then we'll hopefully close it with Jason with the industry changing and being more open to epro ecoa Etc how do you see that industry uh uh shift uh progressing especially within uh clinical trials in in med tech sure I mean I think it's it's really I'm [Music] driving it towards value realization value optimization it's bringing it always goes back to how can we better um bring products to the market faster to our physicians to our patients and so as you think about how the industry is evolving that's really the end goal for everyone right and so embracing these new technologies and and ways of working within clinical Ops if we set the foundation to do that as an industry I think it'll you know we will be able to achieve that end goal of bringing product um to the market quicker um and just thinking out of the box right of of different ways we have some of the technology available to us now let's Embrace that and see how we could you know evolve the way that we think about doing clinical trials in med tech and I think that's that's really the the trend of the industry that we see moving forward also with that is using you know data-driven decisions on how you're executing your trials and how you're managing your patients or doing clinical study design how you're going about site selection um things like that where you're you're using the data through the technology to drive those decisions in clinical trial execution great yeah great points Nick Jason yeah I completely agree about you know using that data right to to drive decision making and and drive the way that you're you're pushing and growing um I think you know we we need to trust the technology right and I think that's the the biggest one of the biggest hurdles that we have um is kind of trusting the technology but if you look at it you know think about all the data to Nikki to your point that we're getting right everything is coming in it's all at the you know it's all at our fingertips we just need to figure out how to look at it and use it to make those important decisions and find those efficiencies um and I think the more that we do that the technology is is really just going to springboard and the industry is going to springboard off of that and continue to grow and develop um you know for us getting getting data how do we get better high quality data faster right how do we get our trials completed quicker with you know less less queries less you know um filing issues less uh you know manually tracking like getting away from all of that and how do we drive that you know technology in the digital platform to leverage it and keep us honest but allow us to run lean and efficient and get those submissions in to get those devices to Market to help patients yeah and and to your point before Jason how you opened it uh you know the idea the previous question being comfortable with being uncomfortable right change for a lot of folks is is definitely not the easiest aspect of anything right a lot of folks going from rotary phone to uh a cell phone right my personal key I was like oh wow this is fantastic and then now we have iPhones I feel like we're at that you know where we're going from the Nokia to the iPhone stage in the med tech industry and making sure that we can make that shift together and and we're able to help each other out and learn from you know what people have done and start to leverage that understanding it's going to be incredibly beneficial for everyone especially with what happened over the past couple years with covid the Paradigm Shift was Aaron and covet was really an accelerator for a large portion of the industry so well thank you guys for for your time um if there are any questions in Q a I'm going to take a look now and then obviously feel free to drop some in the chat as well um but I do have one here it looks like um Jason over to you first so in terms of q a you mentioned earlier that surumo is moving uh from a heavily outsourced model to one where the various clinical systems are going to be managed internally uh in your opinion uh I'm trying to paraphrase this a bit when would it be ideal for an outsourced model for clinical Ops or data management and how do you think that affects the speed of a clinical trial yeah great great question tough one um but a great question so I I think you know you need to look at your capabilities and know what you can handle internally versus what you you need to Outsource um when I think of Industry right now uh you know we may insource as much as possible but there's always going to be some need for outsourcing uh so so you need to know what your capabilities are um and figure out you know where that expertise is and where you may need to to Outsource or maybe you need to Outsource a whole study because you don't have the resourcing capabilities well how do you know that right so now when you look at these systems and the technology that we have I can find that information out a lot quicker and make quicker decisions so you know you gotta kind of check your gut feeling against the data right when I look at you know timelines and things come in and you know that's going to be a tough one now I can look at the data and say hey you know maybe in my mind I thought it was going to be tough but we can do this one but we can't do the next one so we need to start looking at Partners now um so really kind of creating that total picture of your capabilities um where does it kind of increase efficiency again maybe in areas that you know terumo's in sourcing a lot right now right we're trying to bring things in-house but we don't have every function within the organization so there's certain functions that that you know we know we need to leverage vendors and let or Outsource to a cro and that actually increases the efficiency for us because we're not trying to build infrastructure around a whole new Department to run a certain clinical trial we can leverage a partner to say Hey you know we have this piece and I need to Outsource this aspect of it so that we can keep things moving um I think the other part is trying to you know find preferred vendors right vendors that you're comfortable with that you work with consistently where you know you know hey I can hand this this one off I know it's in good hands um and I can turn around and focus on this you know this aspect or these other projects that that are inside for us absolutely yeah um I do see one of the attendees raising their hand I don't think that we have the ability to take live questions like verbally but uh Richard Michael John if you're able to put your question into the Q a or into the chat uh I'd be happy to to read it out and then hopefully we can answer it it did see one hand raised if you're still on the call uh Richard oh thank you Nicole for saying we can't great um so we'll wait for that question Richard uh I do have one here um so we spoke a little bit about Consulting uh I guess Nikki this is going to be over to you uh because it's related to Consulting um what role do you think Consulting can play to make sure the industry is moving together in that collaborative fashion uh more often than not you know it definitely sounds like uh and again paraphrasing here um uh competitors are in the industry what do you think Consulting can do so that we all can conduct trials a little bit more efficient efficiently and effectively yeah I think um really what we can do is partner with the med tech customers to promote kind of again we keep drilling this in but a little bit more of that future Forward Thinking right and transforming how we think about um trials and um it's you know it's about bringing value you know and driving and supporting um our customers and organizations in the industry as a whole to to Really embrace you know the digital transformation using um the technology as it is designed to do but also creating innovative ways of working inside applications but also outside right um and I think you know just creating this community is a big thing we have so much knowledge in this in the industry but how can we bring that together to really Drive um Innovative um different processes and processes and working with um you know organizations and Lessons Learned sharing best practices um so I think we can really what we're trying to do here is really help the industry resolve kind of the recurring pain points in trial execution and guiding you know using the guiding principles and making data-driven decisions mm-hmm great um I don't see any other uh questions in the chat uh or in Q a uh Richard I'm not sure if you did want to put a question in not um thanks everyone for attending this webinar um I will turn it back over to you Nicole um uh for some closing remarks for us and and thank you very much to the Jason and Nikki for for coming along and telling your respective stories about business Consulting and then obviously what the Terumo is doing uh to help drive your change management strategy and overall digitization effort uh inside serum or medical uh over to Nickel think and thanks to mathematic of course for for having us as part of this webinar thank you thanks so much John and I would just like to reiterate thank you to all of you Nikki and Jason John for joining today sharing your expertise thank you to Viva Medtech for sponsoring this webinar um we are only able to put on great educational content like this because of support from our members so just keep that in mind moving forward if it's something you would like to do as well you can always go to mathematic.com under events and find out what we have coming up next um thank you everybody for attending hope you have a wonderful day take care foreign

2022-11-22 12:10

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