AACI CRI: IgniteData Information Session

0:00 well good good morning good afternoon good evening depending on where in the world you are we have colleagues from Over the pond joining us today along long as well as our West Coast and East Coast Cancer Centers so my name is Angela frie I have the honor of serving on the aaci clinical research Innovation steering committee and I'm very grateful for aaci who brings all of our Cancer Centers together throughout the year through our list ser through our seminars and

0:31 through our meetings but also excited that they are hosting this round table today so we can all learn more about one of the EHR electronic health record to electronic data capture systems that's out there so with me today we have the ignite team that will share their about ignite and their road map along with some of our Cancer Center colleagues who are at various stages of implementing ignite and for all of us that are operational leaders

1:03 wondering how you do this in our Cancer Centers because we all know one Cancer Center is one Cancer Center they can share that information with you as well and then we'll open up for just any questions and answers you have for the team so with that I will hand it over to Rich who is with Ignite data Andie thanks first challenge is to try and share the deck on the screen right so let's go there has that worked that's perfect and I

1:35 will try and make it big does that does that work or do you not see it anymore it works but we need to swap because we see your your notes let's how do we do that or if you don't mind us reading your notes that's okay too yeah not AR to important I I'll sh in the interest of time I will share this and then you'll be able to see it and we can go from there let's do that

2:04 perfect I can minimize the size and I'll make it bigger so I only have six slides to go through here and I will try and do this as quickly as possible because I think we're probably the least interesting people on this call today I really want to hear from the sites that are on the I'm getting a little bit of feed there but we want to hear from the fabulous sites that are on the call today so if I just drill in what what is

2:31 Archer what is the EHR to EDC product that Angie mentioned at the start so it is a cloud-based solution which is agnostic of both the ehrs that it can connect to and the EC's so at the moment it's sa for example inside the Epic and cner marketplaces meaning it can be downloaded and put onto these electronic health record systems with relative ease and deployed in roughly four to 6 weeks although I think there might be people

3:01 on here today that will be able to show and present that it could be done an awful lot faster so that's very exciting indeed it can then also connect to these multiple different edc's as you see on the right hand side of the screen here as well so the likes of via and metadata where we have Partnerships to be able to push that data through a multiple different commercial sponsors currently operating on top of the platform it can

3:23 work with all sorts of different data but predominantly lab data Vital sign data is the kind of area that we're mainly working in with Adverse Events coming hot on the heels of that as well very very soon as well as the future of AI as well I won't dwell on this anymore let's jump to the next slide so a key point to know is the Archer is fully covered for the sites so what we mean by

3:50 that is sites are not paying for Archer to be used there is a no cost platform to the hospitals themselves it is the benefit it's the benefit of the sponsors to have this in place at the site driving that commercial research forward and the benefit to both sides is quite large as we're now seeing from the ri on different studies that we're running for the site it's that reduction

4:20 lab and pressure on the site to free up that time but also for the sponsor we see a rapid reduction in the queries that are beinged EDC just G to ask if they could go mute we see a rapid reduction of queries inside the EDC and we also see sdv reducing and hopefully over time we'll see that whole monitoring piece become more efficient as well and of course the labor on both sides all the way through

4:49 that is significant so we have a strong commitment to data privacy the key Point here is that we do not retain any data from the sites so and I think this is what a pure EHR 2 EDC tool should do the idea is that we are piping data from one place to the other we're a temporary custodian of that data so in the US we would have the baa under the hpact in place with the site we are a

5:18 subprocessor on your behalf to move data for a clinical study it's not our place to keep that data on our servers and do anything with it we call that persisting data so we remove it from our system as soon as processing is complete and our sole focus is on EHR 2C so we are not a company that's working on ctms platforms or patient recruitment tools we're not trying to do anything unusual with the data behind the scenes we have

5:45 sole purpose which is the purpose of eSource data transmission and how to do that as well as possible and that includes the Advent of bringing in things like AI as we move forward with this journey so 20 24 was an absolutely massive transformational year for ignite data we expanded across six countries so in the US Canada UK multiple spots in Europe and Australia as well we secured

6:15 seed 2 funding into the business which was nearly $10 million of funding to accelerate the growth expansion and development of the product as well we were able to launch version two of Archer which was a sign ific upgrade and complete Redevelopment of the original platform and it is running well and it is running on multiple life studies now across the world we saw significant Revenue growth and bookings growth and I think the key takeaway message here is

6:43 that this isn't something we're just talking about anymore it's something that we are doing and it's something that is happening on real studies around the world with real sponsors actively pursuing it and putting a lot of studies onto the platform and in 2025 we are going to see a huge number of studies running around the world on top of Archer which is exciting so but the bit that really matters is the data does it does it

7:12 really have impact on clinical studies and again it's easy for me to sit here and say this hopefully you'll hear it from the SS on the call but where it's been used in active studies we are seeing significant gains in the data that comes through so we see a 99.99 9% data accuracy for the data that's transferred versus manual transcription we see a 4.6 out of five rating when we've done nuser assessments of section scores with crc's to understand

7:44 whether or not they like the platform using a licket scale so again we hear from sites they want this it's a benefit to them and they want more we see a dramatic reduction in queries you can see here the number 87.15 especially with laboratory data this is huge and if each one of these has essentially what we could think of as an IT support ticket behind it which is causing both the site and the sponsor to

8:11 burn more time to go backwards and forwards this really is the Revolutionary statistic here than 6.8 times faster data access what that means as a use case example on one study typically 20 to 30 days post the patient coming in for the visit we were seeing that in the EDC within 3 days which is staggering when we think about risk-based monitoring and other practices that are coming to the industry now getting that data faster more efficient giving the sit what they

8:41 need is key and last slide before I pass the mic on why is ignite data the Strategic partner so we're running across multiple life studies around the world in different territories at the moment and these are regulatory grade studies this isn't a sandbox sand pit anymore more these are real regulatory grade studies where the data is flowing into the EDC on real patients for real submissions into Regulatory Agencies it's compatible with multiple EHR and EDC systems as

9:12 we've seen on the first slide we're working across Viva metadata epic CNA Etc and bespoke Integrations as well so Archer is designed to minimize that manual data entry seamlessly for the site which hopefully has come across in my talk and will come across from others on this call and installation is seamless with a fabulous team behind the scenes supporting it Angie that's all I've got I'm happy to pass the mic back across thank you so much Rich so I'm

9:42 excited to turn it over to our Cancer Center leaders who have are at various stages of implementing ignite at their centers and so as you can imagine we've all had different experiences so we want to to share and see what questions you have but I also want to take a second to recognize all of our corporate Roundtable sponsors who have also joined us today AA is very grateful to all of our corporate Round Table sponsors and

10:11 we look forward to finding new ways in 2025 to bring our sites in our corporate Round Table members together and this is just the first of many so kudos to all of our pharmaceutical sponsors that are attending today and want to thank you again for supporting AA everything you do to help support us making all of our contributions possible really very grateful so as I mentioned we have a couple cancer centers that will be sharing their experiences and we are

10:40 going to go in order of where we're at in the process so starting with someone that's very new in the process to one that's fully implemented for a couple years now so I would like to introduce you to Lee Andrews from MD andreon who will share his experience so far great thank you Angie and I'll start off by saying I know it looks like I'm I'm staring up at the sky here I'm in a conference room and there was no camera

11:06 so I projected and I'm looking at all of you but I know it looks weird so bear with me but good to be with everyone this morning as Angie mentioned Le Andrews I am one of the executive directors in our technology data and Innovation group here at MD Anderson so the perspective I'll provide this morning is very much from the technology out of the house also as Angie mentioned we are very early in the process we are had our actual kickoff

11:37 call for our first study yesterday I will also mention that I have Chen from ignite data in the room with me I don't know if anybody there's Chen all right we had actually happened to have an onsite discussion today so it just worked out that he was able to join me in the room but I I'll provide a little bit of perspective on our journey so far so backing up really four or five years ago we started working with

12:10 a couple of different companies on the same type of concept the same type of EHR to EDC concept and it was less than successful I think really the challenge was at the time their ability to scale we didn't end up standing up a couple of small poc's it was a little clunky things could have gone better and at the end of the day we decided just to

12:41 kind of back out of all of that and wait for a better solution we had actually talked internally about whether we wanted to develop our own solution but ended up not going down that path so about I guess a year ago we were introduced to the concept of ignite data had some early discussions we spent as many of you can probably relate some time in Contracting we are a state

13:13 organization as you may know so there are unique challenges that come with Contracting there although I will say even though we could not use ignite data's standard contractual form they were very willing to work with us very minor changes and we were able to get that once we had the S so and things all kind of packaged up able to get that through pretty quickly and I I want to go back to Something Rich mentioned as well which was the fact

13:44 that ignite does not store the data which for us was a big thing there's all kinds of additional contractual discussions that happen based on that particular statement about whether or not the data will be shared outside of the institution or outside of the institution sponsor relationship so that was another win for us in the Contracting side of the house as as I mentioned we're we're

14:16 early had our kickoff meeting yesterday but I will say the process in order to get to that I Heard four to six weeks to stand things up once we finished with Contracting we were done in 10 days have been super impressed with the organization the process the speed at which we've been able to move ignite's been very helpful in kind of guiding us through the steps to take

14:46 in order to get things functioning appropriately so very optimistic on expanding this in the future I I won't take up all the time here we've got other people there are other comments I can make but I will hand it off to the next one and then we can come back around to me if we have time thank you so much Lee so next we have Annie from Mayo

15:17 Clinic right thank you so I just wanted to talk about the experience from Mayo Clinic so I'm Annie Alazar I'm a senior program coordinator here at Mayo Clinic and I'd just like to take a few minutes to share our experience with the initial implementation of Archer technology overall the integration has been an overwhelmingly positive experience our study teams are excited to utilize archer in upcoming studies

15:48 and we're looking forward to the ongoing benefits it will bring as it was mentioned the initial deployment of Archer takes about four to six weeks here at Mayo it took just a little bit longer than that it took about eight weeks and during the initial deployment of Archer during there's a pre-project phase and during that phase we evaluated the clinical trial data needs to and

16:18 identified specific data points that would need to be mapped in a test environment ignite data was great they helped us to set up the appropriate Archer configuration for the trial we work closely with them to ensure that the study and with the study team to ensure there was accurate data mapping during our kickoff meeting we discussed and aligned on the project objectives roles responsibilities timelines as well as technical requirements needed to ensure

16:50 a successful Archer implementation from our standpoint the technical deployment took slightly longer than anticipated and that was due to internal committee approvals required before we could bring it up to the test environment however this was not a major setback while waiting for the internal approvals it wasn't a hard step so we were able to kind of forward on with our our

17:24 testing we also found that if we created a test patient by the name of Tracy Archer we could use her to develop test scripts and then this using this dummy patient in the EHR ignite data set the fire mappings to retrieve the data from Tracy archers EMR based on link mappings we received internal committee approvals and once we had that all wrapped up we were able to complete the testing of the technical

17:57 deployment we select SED the Archer app in the Epic showroom we ensured connectivity was successful and then we work to identify the training date to work to Ure all data points were accurately transferred from the EMR to the EDC upon completion of the nonproduction testing we transitioned to this test study into production and it it went seamless

18:27 you know I can't speak loud enough as to how easy it was we had some internal committee approvals that needed to be done so we had a clinical practice committee which oversees the implementation of projects utilizing Mayo clinics EHR system to support the practice Education and Research technology within Mayo the committee I can say was impressed with archer capabilities we even had one

18:58 member remarking Archer where have you been all of my life so the committee formally endorsed the implementation plan recognizing archers potential to enhance the clinical trial data management following this we engaged with our Comprehensive Cancer Center which also expressed strong support for Archer they highlighted the capability with various EHR and EDC systems as well as the robust data

19:29 security measures to ensure no patient data is compromised I know during we recently had our first sponsor initiated kickoff meeting and we're be excited to begin our inaugural investigator initiated study in the coming weeks we've also identified a second sponsor initiated study with the same sponsor as our first and we're actively collaborating with another

19:59 sponsor to explore potential studies I believe my fellow panelists will be discussing updates to master agreements with the sponsor and so with that I think Matt was gonna highlight thanks Amy Matt Bush I'm one of the executive directors from City of Hope within our clinical trials office and my team has been serving as the main lisons with the ignite data team as we start to implement this tool

20:30 so just for some quick background how we ended up with Ignite data a few years ago we had done a pilot with a sponsor about a homegrown EHR DDC system and we found some very promising results from that we saw some very significant Time Savings and some really good experiences from our coordinators that were involved but I think the biggest challenge we had with that was looking at scalability across multiple studies and then moving on to additional sponsors so we engage

20:58 with the night team I want to say close to a year and a half ago and for us I think there was a lot of kind of initial discussions kind of exploring going through the Contracting process I think was probably the biggest barrier but that was more of a organizational specific challenge than anything else but we did just go live with our very first study about three weeks ago at our main site in DTE and this week we

21:20 just went live with our with on that same study at our site down in Irvine so we are actually up and live and very excited to be testing this with real studies with real data and real patients from an implementation standpoint I would say we were probably in that more of a six to 8 we time timeline for implementation that was more I would say due to kind of internal like Annie was speaking to some internal

21:44 approvals making sure we're going through the right Change Control process and getting the right projects sign off from the various teams that we're working with specifically with an epic since C def hope is an epic client I would say something that is different for us I think compared to what we heard from some of the other speakers is we are actively now working with two to three other sponsors to start bringing up additional studies with new sponsors apart from

22:11 the original we were starting with and I think something that we've been very encouraged by is the lack of duplicative work we've had to do as we start looking to partner with new sponsors and on the new studies a lot of that initial mapping work that we did up front really has paid dividends because the setup as we're looking to bring on a new study is much much less than that initial workload of getting everything set up installed so that's been a very

22:38 positive experience for us and we've been really encouraged to start seeing how from a scalability standpoint ignite data and Archer really seems to be checking a lot of the boxes with us so far as Annie mentioned from a Contracting standpoint with the individual sponsors we've just been managing at IND individual CTA level but I do know we are to see can we get something more robust in place at a potentially a master agreement so that we're not having to negotiate use of our

23:05 trip for each study as it comes in but overall the initial feedback from the first couple weeks from our coordinators using the tool has been very positive and the initial feedback is really pushing us to start seeing if we can get more and more sponsors engaged with using the tool moving forward so overall a lot of the similar experiences that Andy and Lee Shar just from my implementation and U kind of setup standpoint so I won't repeat all of that

23:32 but we're very encouraged and I think it's we're really going to continue to push U more adoption with this we are also really excited to start exploring the possibility I think Joe will speak to this some about leveraging Archer for some of our iits as well since we're a metadata client for our iits that is something we do want to start exploring and seeing can we get start using this internally because there's defin a definite time Sav for City of Hope run

23:59 studies as well so that's one of the next big things we'll be looking at hopefully in the next few months thank you so much Matt before we switch to Jo I just want to highlight that Archer ignite data has a wonderful onboarding packet like a whole workbook template that really helps the sites so that your hand is being held by the ignite Team every step the way through it's been really helpful and they also come on site as Lee highlighted chin

24:31 is chin from ignite data is currently at MD Anderson they come on site before we go live to help with change management they'll meet with anybody any stakeholders you want to really make sure that the staff are excited about ignite data that this is not going to replace their jobs because we all know part 11 compliance requires a human validation so our teams will still continue to sign off and validate and approve it's really getting our staff to

24:59 work at the top of their license and as soon as the staff hear the amount of Auto queries that decrease everybody gets excited we're not we're really overcoming the whole Auto query sponsor versus data coordinator versus monitor all of that is really starting to go away so I just wanted to highlight that as we transition to Joe from msk who I believe has been on this journey for about two years and excited to share what he's

25:27 learned in his journey thanks Angie great great to see everyone great to see such a a large group on the the call today I was I was able to to talk to this aaci group about maybe nine months ago about what we were doing at at Ms in terms of bhr Toc and working with Ignite and and so it's great to see the the progress we've had not only at msk in those nine months but in the larger

25:54 industry and I I thought that's what I could kind of spend my time talking about and actually prepared a few slides to share as well which I'll pull up to talk about some of the data some of the results we're we're seeing at msk pull this up let me know if you can't see it let me introduce myself first for for those of you I haven't had the pleasure of meeting I'm Joe Len felner I lead the clinical research

26:20 informatics team at mskk so it's it's my team's responsibility to to manage all the the systems we use use in our clinical trials program and that that includes our data management processes our EDC systems for both internally investigator initiated studies and also our our sponsor studies and so as Angie mentioned we we've have been working with Ignite for for a couple of years now and it it's it's been a great experience so far and I think

26:50 you'll you'll you'll see why we're happy when I start to to show some of the the the data we we also and I'll I'll pull up a slide that kind of talks a little bit about our journey like the previous speakers we we have looked at at other Solutions in the past this direct data exchange or eSource or you know whatever you want to call it idea has been something that msk has really been prioritizing for for several

27:16 years and we've we've shown the the ability to do this on a a small scale for you know a couple of studies here and there and really have shown the the value of this but never and I think it was maybe Matt that mentioned you know haven't seen that scalability our our strategy is really to implement a tool across our entire portfolio of studies we want our entire research cordinator Workforce working in the

27:47 same way whether they're working on an msk investigator initiated study or on a on a sponsored study and so when we are looking at at vendors and and looking at some the reasons why previous vendors didn't didn't pan out what we really wanted was a an agnostic solution that could connect to different data sources at the site level where I can go into details if anyone's interested but we're not actually connecting directly to our EHR we're connecting to a

28:14 research data warehouse so flexibility on the the the site side was important but also flexibility on the the sponsor side so we wanted a a solution that would that would connect to multiple EDC systems so that we could be using one solution across all of our portfolio so ignite did check check those boxes for us we also wanted to partner with a a technology provider that had sponsor relationships so we

28:44 really wanted to you know we're going to spend the the time to implement a solution we wanted to make sure that there were going to be studies on the other end sponsors that were ready to go and and ignite has done a tremendous job in building those those sponsor relationships and we also wanted a collaborative partner we understand that this you know technology is still evolving that you know this is going to continue to to grow and there's going

29:09 to be new data sources and and and and ways we have to work together to push this this forward and so we really wanted a a partner that was going to be collaborative and and work closely with us on this journey and I think you've heard that from from other speakers as well today that that night is is you know really good at at partnering closely with with us as we as we roll out new studies so to to share some some data we

29:42 are really seeing we're kind of reaching that point of scalability now this is a few charts that show the amount of data that we've push through Archer ignite data on a quarterly basis this is organized the the top left is for all studies the the chart on the right is for our IIT studies and then the bottom is our sponsored studies and you can see across the board last quarter we just knocked it out of the park just you

30:11 know huge expansion on both this the sponsor side and the investigator initiated side as well the the data from from q1 maybe I should remove that from this slide just because it it you know looks like it's going down but of course that was just a few days into 2025 three days into 2025 and already well on our way to probably you know doubling the the bar from last quarter so really nice nice growth and that that makes us must happy we're

30:41 also and this is a sneak peak of a a presentation that we'll be giving later this this spring there also be a publication where we were looking at a randomized set of of studies and really working to prove out the the efficiency gains the quality gains the the user satisfaction numbers that that we're all seeing but really kind of try to do it in a very methodical

31:11 scientific Manner and so this is some of the results of of that study and I can share the the larger publication when this with this group when it's ready this is looking at the the increase in in data entry speed across those five randomized studies studies and you know across the board really significant gains differences based on the the years of experience with the coordinator the complexity of the study Etc but it's all all very very

31:42 positive and so just wanted to end the prepared slides on saying that you know for us at msk and I think for others on this call it's it's really about scalability we've shown that this is is possible that there isn't the need to do pilot after pilot to prove out that this is a this is possible that we're really at a scalable a time to scale this this technology and so there are several industry groups that that we partner

32:10 with at msk and I know others on the call do as well that are are helping to to push this this Vision forward one of those groups is Vulcan hl7 fire so one of the the technical capabilities that ignite leverages is the the Fire end points that are coming out of vhr systems the US and and starting in in other countries as well so Vulcan is is really active and in pushing that forward and another group I get to work

32:37 very closely with is ihd more focused on the European side but they're they're now starting to collaborate with with sites and sponsors in the US as well the the work we're doing here and I I call this out because others on the call might be interested in looking at some of the deliverables from from this group that are creating really playbooks and and kpis and and other documentation that can be used to roll out EHC at at your site so if

33:08 you if you search for for IHG you will you'll come up with with this site that can give you some some good resources to to help you roll out of your site as well and I will stop sharing there and pass it back to Angie thank you so much everyone so we do have some questions in the chat that we can address first and then we'll open it up to Q&A or if you would prefer to put questions in the chat our

33:34 speakers can address if you're shy you can message me privately Angela frie and I'm happy to read your questions as well so our first question is are you seeing Archer can be used eventually for all studies in the portfolio or or is it too early to tell whose perspective would you like

34:04 first Rich let go with you and then maybe Joe cool so that's the that's the core aim of of why why we started the company why we why we wanted to build the software the the approach of creating something that was was cloud and we had the right kind of political environmental infrastructures to be able to do that post the 21st Century Kid Act is is really all about Market timing and I think you know that market

34:32 timing presented itself to be able to build something that could actually finally solve that problem at scale and now we're in that position where we're getting that site Network in place and we've got those large sponsors coming up behind it many of which have now signed Enterprise agreements with us so you know it's not something I can talk about publicly in a lot of detail but we know we've got this tale of a large volume licenses and commitments to drive these

35:00 studies from a commercial perspective so we see it as how do we how do we work together to now address this with the rest of the farmer industry how do we get those people that aren't as adventurous as say the Astro zenas who are in the public domain for using this to come on board and move quickly and I think Joe hit the nail on the head when he was talking about you know H it's ba

35:24 now it's it's time to go this is generally available ball we need to get that mindset shift in the industry cuz for a long time I can remember when we started the company people were telling us we were wrong every single time you went you approached a cro you approached a sponsor you approached an investor and they said no no you can't solve this people have been trying to solve this for years and we must have a certain

35:49 amount of stupid because we kept going we kept doing it and then eventually you prove it can be done I can remember one of the founders of medad dat telling us that you're wrong and this can't be done and you know now we're doing it and we're putting data into metadata and you sure Joe statistics there a lot of that data is flying into rave on a daily basis so I think we've broken that idea that it can't be done and we've moved to

36:18 the point where there are live regulatory grade studies running on the platform and we're seeing the numbers of patients scale up every single month so it's the start of a journey now how how do we work together as quickly as possible to get the industry to move I think is is the short answer to the question rather than can we yeah agree with everything rich rich says I I'll add on the the the strategy behind the you how we'll apply

36:44 this to our portfolio yeah we are we are using it for both IAT studies and sponsored studies and and that is the the strategy from msk is want to put this on on on all of our studies as I mentioned really want our our coordinators working in one way across the studies I was I was talking to my team earlier today and our our goal is to starting March 1st to every new IIT study atsk will will use we use

37:13 ignite data and then of course there many sponsors that that come as well thank you Joe that oh go ahead I was just gonna add Angie I I think same story here obviously were very early in the process but we are very much looking forward to moving this into support our iits as well we're in Adara shop here from a EDC perspective so I'm looking forward to I think some of the conversations that ignite data is having

37:45 with them on how to improve those Integrations so same story here thank you Lee and for Mayo we also use metadata for our I and we are going live actually with using one data coordinator who is going to support all of our Mayo sites so we picked a trial that's going to be up in Arizona Florida Rochester and our health system sites with just one person supporting that trial because we have one integrated EHR so we really want to

38:17 test and show how we can also support our community- based sites using this as well so we're really excited and happy to share those updates as we join as Annie mentioned we have one interest sponsor that we are going live with study looking for a second and hoping more sponsors come because the staff are just so excited kind of what other people loaded to it's easier for our staff if there's only one solution so we're hoping that more sponsors will

38:48 will use this especially if other cancer centers are coming on board as well but that's all to be determined so that leads us into the next question I Know Rich you're kind of bound by what you can share only what can be what's publicly available Lily did mention that they are just starting but are there any Pharma partners that you're able to share legally that is using ignite so because Lily have shared it and not me that's that's one yeah we are we're

39:20 working we're working with Lily and they're obviously a viva viva shop as well over there so that's been a very interesting project to get them up and running astrazenica is the other one that's very public and astrazenica have been fabulous Partners they in the early days they really were a true co-development partner W with us and I I can see Joe nodding on the camera because they worked they worked very closely with with msk it was a real

39:46 partnership through those early months and and years to make sure the tool did both more importantly what the sites need but also delivered the value that the sponsors needed as well there are then a tale of a lot of the big names behind them one is due to go to a press release in I think about the next two weeks so I have to not say anything until that point in time so I'll be quiet and also I don't know who's on

40:15 this call so I might I might put my foot in it if I'm not care I'm not familiar with our legal agreements but as a site can we share who we going live with our first study or no I don't need I don't know our legal agreements very well I'll just not I'm not sure okay next question could you give some examples of what data can be pulled from the EHR into the EDC versus what data

40:45 will still need to be entered manually by the site staff and for those that you're not currently pulling I'm going to add lib what is the road map for being able to do those yeah I could answer this but it might it might be better for one of the sites to chime in first with their with their experience of the coace then I can I can back fill I can start because we pushed the the most data through so we're doing

41:11 that highly structured data to start and that that was by by Design so Labs vitals medications been working very closely with Ignite to get our adverse event we we're lucky to have our adverse event data in very structured format Within msk as well so working closely with Ignite on on Adverse Events and hopefully tumor response coming coming soon rich I know you I I I think I saw publicly that you announced a partnership with a a company

41:40 that's doing structured tumor response measurements and now you're going to be able to push that data through through ignite that's correct so we we partnered with a company called unu who specialize in imaging for research specifically and we built feeds into the back of you new system so if those images are flowing through their system we can query their database much like an EHR but it's centralized in the cloud so if by chance you're using that solution at any of

42:10 your sites it really expands the amount of sort of metadata around the images that we're able to push through but then just to expand on Joe's context that he's given there a lot of lab data a lot of idol sign data a lot of demographic data concominant medications is a key area we're looking at there are a lot of nuances there because a lot of medications Keds go into the medical record in FreeX so we need to look

42:37 around Ai and duplication as well so if anybody tells you that easy it's it's not it's it's quite a complex Beast to overcome so that's something we're working on at the moment and we're currently testing two different NLP models at the moment we've been actually working with msk on that on a large data set of around 7,000 patients to push that through look at that named entity recognition tagging and doing a lot of wireframing around how that could

43:07 integrate with the platform now that opens a lot of new problems like where does that data reside how do we work on deidentification how do we keep it gcp compliant all these kind of things but it's it's certainly a work in progress and it's very exciting the kind of data that we're getting through that at the moment so I think you know to at the point at the start of the presentation we we want to be a we're trying to be a

43:32 dedicated eSource provider that's that's what we want to be we don't want to do other things we don't do patient recruitment our focus is on how do we help sites analyze and gain access to their data and as much of their data in a way that's efficient for running clinical research and that that's a big big problem domain in its own right so there's a there's a long way to go but I hope does that I hope that answers

43:57 question I think that does Christy Johnson kind of piggybacked on that though transmission product they're currently looking at has limitations on what data can be transferred to the EDC as we know structured data is easier to pull than unstructured data but you kind of highlighted The Journey your ignite is now on for going after the unstructured data but do you know how many data points are embedded within physician notes have proven difficult to extract you kind of alluded that I

44:31 think your future vision is to overcome but that's the spe specific question will ignite hopefully be able to eventually overcome that challenge we all face yep yep and I would I would say the data that's coming out the research projects at the moment suggests that we're definitely on the way whether AI is the entire solution to that or not I I don't know at this stage I think it's about making sure we've got human in the

44:55 loop and at the end of the day we we still need the crc's to be able to review that it needs to be kind of lift lift the hood of the car and have a look underneath and confirm that you're happy with it and and push it through but it's a journey we're on and I think if we can get to a point where we're reliably getting 80 to 90% of the data that's in the free text notes Imaging things like

45:16 EOG scores that will be a big step up from where we are now the question is can can we do that reliably and can we build that into a workflow that works for the sites and the site staff in a in you know a user experience that works for them as well and that's the great challenge is you can build a point-to-point AI model and present something on the stage that looks great but turning that into a scalable

45:39 solution is the challenge and that that requires a lot of thought a lot of thought especially around where the data resides and how you manage it and as we all know we all have our data in different places so absolutely hence the conundrum of one the cancer center one Cancer Center I believe Courtney's question that I'm going to read is for our sites at UCLA we have an API manager called axway which has historically presented a

46:06 hurdle for scalability on EHR to EDC platforms do any of you have something like this in your Enterprise we don't we use corepoint kind of as our integration engine when working with epic our experience is that did not cause any challenges and just working as I think Angie had alluded to earlier the ignite guide book for pulling down the app getting installed in Epic and going through the process was actually very straightforward and really didn't

46:38 encounter any issues in in that regard same here we use iguana as our interface engine here no no significant challenges as we started walking through the first piece of this Rich do you know if your team has experience with axway specifically we do not okay we do not but where we've worked on bespoke Integrations you know msk was an example

47:10 of a bespoke integration we're currently going through two other bisoke Integrations one in Germany with the hospital around there and another major Cancer Center in the in the UK you know and they all come with their own challenges but for the most part with the fire servers and you know we using the smart and fire launch I'm throwing some technical terms out here you know it it it tends to be straightforward over the old style integration engines

47:37 where you're kind of pumping data around to different places so yeah I can't comment directly but it's certainly something we'll be happy to look at I think we've all had different experiences with vended products as Cancer Centers and so I hope that you've heard today that ignite dat is very sight friendly they really hold your hand to the whole process and So Courtney you know if you want to explore this with the UCLA I Know Rich chin and

48:06 team would be happy to explore that with you further and give you a better answer so next Leslie has a question avara EDC is the system we use for iits have you been in discussion with them could you repeat the question for me Angie yeah advara electronic data capture is the system that another Cancer Center uses for their

48:38 iits where are you at in the process with adedara yeah we're talking to them at the moment they don't have public apis so there is ongoing discussion with our technical product team around this so yeah working on it working on it and I think Lee you mentioned you're using advara so I'm sure you're advocating for that that that's right yeah there are about a million other reasons we'd like to improve on that

49:09 integration but yes that's correct thank you any other comments from Annie and Matt I don't want to leave you all out okay a couple of questions one I think I heard initial implementations across the different sites took from 10 days to eight weeks if you did not have the internal delays such as our committee approvals how long would it take and approximately how many person hours were

49:40 required so one Cancer Center one Cancer Center answer so I think we'll round robin across the four speakers to share their answer to that question so I I'll start I guess we had I think think one one and a half people who had worked on setting things up to do the initial piece of it like I said they spent 10 days but

50:11 probably maybe 10 15 hours total between those folks over the two week period for the second part of the question I don't know yet I would assume it will go down as we onboard additional studies but TBD yes and I can speak to Mayo it took us in total about 8 to 10 weeks but that is because we had the internal committee approval if we did not have

50:43 the internal committee approval it probably would have taken us probably six weeks overall we had different people working on different parts of the project but in total it probably took maybe 20 hours hours to get everything up and running kind of the longest time point we had with hours was ensuring that we had all the Lo codes properly and correctly identified because that is where all the data is mapped so we took extra time to

51:15 ensure that those Lo codes were correct and kind of went back and forth because they could differ a little bit so we took that was most of our time internal effort required to on board each study is now since we are getting our first study up and running I've noticed it's taking probably about 1/4 of that time we put together some forms that kind of identify that we can send off to the internal teams that we

51:44 need to set it up you know we already have our test patient established so for every study that we have to utilize Archer it will always come under the test patient Tracy Archer and we'll just enter in her data but I can say you know we're looking forward to it being less and less effort with each and every study we on board yeah I agree with Annie I think that 20 hour estimate is probably a pretty good one for us and I would also

52:13 Echo I think the loin code mapping up front is probably what took us the longest but I think that is what we're seeing the benefit from taking that time up front because as we're bringing on more studies it's only a couple hour exercise it seems for the next set of studies we'd have coming in so spending that time up front doing your due diligence and really working through that loan code mapping really was a big benefit and we're definitely seeing

52:38 the benefits and for us the the test patient I would definitely want to call out as being something critical to get up get set up and get set up properly we had some back and forth with the Epic directly to get that done correctly there were some questions from our security team in particular but once we got through those now also have that test patient that we can use going forward and that's been beneficial Joe yeah for msk I'd say we're on the

53:07 you know the eight-week side of of the the range but but simply because we were doing something very bespoke at at msk we were launching from a a homegrown research system we were using a a homegrown fire server to connect to Archer so it's very very custom and you know thanks to to chin and for for working closely with us through that process but if we were just launching from directly from thehr it would have clearly gone much much

53:35 quicker what are you seeing now that you've been on it for two years and you've had a lot more studies the internal effort compared to that first study which is a little bit unique for the compared to the rest of us to what you're seeing now about how long does it take you to your team to get a study up and going a a week probably and that's of course not you know fulltime time it's you know going back and forth

53:58 between U I have one one person on my team that's responsible Anna who who onboards every new study she's working with the the study team to do a very light uat on the the mapping since we're reusing that mapping over and over again it's it's a very low lift for each new study so a quick uat there a training for the study team if they're they're new and then we're up and running so yeah definitely economies of scale in

54:22 terms of onboarding new studies we have several more questions and only five minutes left so for iits Rich are you able to share it's a discounted rate for academics versus sponsors I don't know what else you can share but it is by study correct it it is by study yes and and yeah there's a there's a significant discount on on academic IIT studies versus commercial studies and Joe try keep me correct here

54:55 the the cost far out ways or is further reduced by the benefit and the return on investment we get from cost Savings of time yeah not a not a hard sell to to our leadership no it it it does far outweigh the the investment thank you what are the EDC you are working with in addition to metadata yeah sure so we we work a lot with metadata Viva is another key one

55:27 where we've got a strategic partnership with them and we'll be speaking at their conference later this year we're also starting to work quite closely with open Clinica early conversations with Adara have be mentioned on here as as well and historically in the past we've got a cter connector as well but it's not it's not commonly used so it's driven by the people who are using the platform that warrants us building out those connectors which individually is a job because those edc's all speak

55:58 very different languages the way their apis work is different and the form even the form structures the theory behind how they design the data capture is is different so the metadata connector for example is a very very big beast when you look at the code behind the scenes to be able to manage all the different form types that they use and every sponsor is different so even though much like on the ehl side right you've seen

56:24 one Epic install you've seen one Epic inst same thing applies for the edcs they might use Rave but my word they they they build it I see a lot of people Notting on the co they build it very very differently so building those Dynamics into Archer has really been front and center of the research that's happened over the last few years to get to a point where there's a very stable system so a breadth of them

56:48 especially on the commercial side you know all the major players in the market we're we're integrating with the edcs that they use thank you so we have three more questions but we're going to take those offline and respond to the whole group you can all hear the answers I want to be mindful of everyone's time today I want to thank ignite and our Cancer Center colleagues who joined and shared their experience also want to thank gench Gilead Johnson and Johnson

57:17 Lily and Mark who are corporate Round Table members supporting aaci and CRI you do so much for us all year long so thank you and thank you for joining today also this will be recorded and so we will share the link with you all and you can forward it all to whoever you want and after we send out the email with the link and the answers to these questions we will also ask of one question survey do you want to have

57:47 a followup on this topic at this aeci CRI meeting at the end of June so I'm seeing Dan NS we'll probably have this conversation at our corporate Round Table member but as Cancer Centers if you would like to have a breakout session or more discussion on this we're happy to bring that to that meeting in June in Chicago as well so for those who have never attended it's all about how we do things in our Cancer

58:16 Centers sharing best practices sharing best operations this is just a sneak peek of kind of that that June meeting so please if if you haven't attended consider attending so with that thank you all so much I hope you have a great day and we will be in touch thank you thanks Angie thanks everyone