Future of Oracle Clinical, Oracle RDC, and Oracle TMS

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Future of Oracle Clinical, Oracle RDC, and Oracle TMS

Hello everyone and welcome to the webinar titled The Future of Oracle Clinical, Remote Data Capture (RDC), and Thesaurus Management System (TMS), presented by BioPharm Systems, Vicky Green, Director of Client Relations and the Director of Product Strategy, Chris Huang I am Eugene Sefanov, the marketing manager at BioPharm I am going to go over some short housekeeping items before we turn with Vicky and Chris During the presentation all participants will be in listen only mode but any listener may type in a question into the chat feature Other participants will not be seeing your questions or the comments and if we have time we will address any questions that have been provided Just as a reminder today’s call is being recorded and will be posted to the website in 24 hours We will also be emailing a link to the recording This concludes our housekeeping items and I would like to turn the call over to Vicky and Chris VG: For our session today, we are going to do welcomes, Chris and I will introduce ourselves then I will go through a brief set of intro slides and we are going to be discussing the ORACLE CLINICAL/RDC products that Oracle has released just to go over a bit what is out there Then we will be talking a little bit about the future plans for the releases and share a little bit about the strategic development program that Oracle has been working on with different companies to get the requirements for the next releases Naturally these releases will be the Amber release, go through a summary of information about that release and then the last section that we will go through is the roadmap for these products going forward Then at the end is the question and answer session where we will answer as many as we can For those of you who do not know me, I am Vicky Green, the director of client relations here at BioPharm I have been in the industry for over 20 years, with CROs for 15 years, and I have been with BioPharm for 3.5 years and here I work closely with the ORACLE CLINICAL/RDC customers and I also work very closely with BioPharm hosting and support customers and work very closely with them as they move forward with their journey with these products What I would like to do now is turn it over to Chris to introduce himself and I will come back and go through a couple of additional slides and then I will turn it over to Chris I want to say thank you for everyone attending the webinar today and Chris and I are excited about this program and have spoken to you about these products and tell you about the commitment Oracle has, and BioPharm has, to these products CH: Thanks Vicky and hello everyone My name is Chris Huang, and I am Director of Product Strategy at Oracle so I have been

in the industry for over twenty years, started in data management in the early nineties and went on to work at BBN and then on to Oracle I have been at Oracle for a little over eleven years, I have probably met quite a few of you over the years and ofr the past three plus years I have been in product strategy and acting as the lead strategist and product owner and defining the vision of the product VG: Thanks Chris As many of you know Oracle and BioPharm have a very strong partnership BioPharm is a gold partner of Oracle and that is very important to us as today we have worked closely with Chris to hold this session and with our customers and they want to know what is happening with this product It allows us to sell Oracle licenses, including perpetual licenses, under the BPS program that we have been doing for several years and also naturally we do a lot of implementations and upgrades and accelerators out there A lot of you that we work with, we do offer services around implementations and upgrades, have experts in data management and study set up and training so there is a wide variety of services that we offer around these products We also have added many products that will enhance ORACLE CLINICAL AND REMOTE DATA CPATURE products so as well work with customers and learn what their struggles are, with packages and validation, naturally that is a costly thing so we try to come up with things to help our customers, some of our new products like Accel, so we are trying to offer additional solutions to help our customers I will now turn it over to Chris to talk about the strategy and things that are coming up in the products and hope that you will get the information you need today CH: Thanks Vicky, I will be taking us through the remainder of the slides, just to talk a retrospective view on the past releases of the last few years, up to the current release and then what we are working on today for Amber 5.0 and how we interact with our strategic development plan and talk about a bit of the Amber release and show some preview slides on the upcoming features then talk about the technology stack of the upcoming release and upgrade map If we go back to 2009 the 4.6 release was very important, a lot of functionality was released in 4.6, right at the top there is the support for flexible studies, multiple arm trials, patients down to various paths, based on the study design so that required enhancements to our DCI book and DCI rules to dynamically enable and disable visits and pages based on answers to critical questions as patients went through the study

Also, in terms of productivity, a multi-page patient assignment feature, having access to controlled DCI level and then usability, within a CRF to have branching capabilities, hide questions and also hide them preventing updates to other discrepancies then with 4.6 we started with a theme of scalability enhancements that we have been focusing on for the past few years because as our customer base continues to grow and use the application there are always customers who are pushing the envelope on scalability so in the 4.6 release we started with some enhancements there so as studies became very global in nature the ability to enter data and perform batch data validation without failing because say a page is locked, well, starting there, there was an ability to perform the duties without batch data validation failing Also there were changes to scalability to set up multiple JDMs and then better handling of intermittent connections, so if there is a poor connection it will prompt users if they want to reconnect And always with a release we are looking at updating the technology stack Then I like to refer to 2010as a certification release after that major release we wanted to focus on key technologies that our customers have wanted us to certify Active data guard, to enable theft recovering, the Linux database and certification around the client One new feature in 2010 was the actual extended text feature driven by the need to capture SAE narratives so we have customers that are capturing information on their SAE page and then send that to their safety system In 2011 we released the 4.6.2 and with that we continued with key certifications, and then also updating the application server and incrementing the data versioning One enhancement was released in the 4.6.2 release which was the ability to filter a source DVG popup based on the study site After that release we made a transition to a patch set approach for releasing patches There are various benefits, By targeting quarterly patch sets when they are coming out is more predictable but for us it is more efficient in that we can put out more patches in a patch set versus one at a time or several at a time and we are up to 4.6.6 now and we have had more patches We have stopped some patches for the moment as we focus on the Amber release To talk about some of the key strategy trends for the next year and half to two years, continuing to work closely with our customers, our strategic development partners, in the program and work with them to prioritize and validate some of the key features in each release so we have worked closely for the upcoming Amber release and other releases afterwards I would also like to point out that key points in the release schedule is to open it up to

the broader community and the ORACLE CLINICAL/RDC foc sub group as well as the admin and config focus group to get a broader feedback and maintain that customer focus It is important to stay on top of the industry to make it more flexible and configurable and a good example of this is the partial STVs that we are going to be releasing in the Amber release and the release following that Scalability is very important to us for our very large customers which re looking to support over 2000 users in the system and looking at technical and functional enhancements to handle that extreme deployment Then lastly usability, something we want to enhance in the system for both site users as well as sponsor users and really providing a greater user experience to result in higher productivity and satisfaction, I will show some of that which we will be providing in the Amber release So now we are going to be talking about that release, the 5.0 release coming up and with every release of our products we always try to identify some of the key these and some of the key themes around our upcoming Amber release are availability and scalability In terms of availability it is multi browser support, Chrome and Firefox and Safari, all these things are slated for the Amber release and as we do have customers that are running some ORACLE CLINICAL AND REMOTE DATA CPATURE on very power exodatabase machines which can provide some extreme performance it is certified against that and can support RAC so I will talk about some of the enhancements we need to make to support that Also in terms of technology uptake we will also move to the FMW 11G and the database really allows us to think about time we move to 12C which is the latest version which is on availability Then on the second theme is on risk-based monitoring and regulatory compliance so the partial SDV is one of the things we are going to be having on the Amber release to support reduced risk based monitoring and also some enhancements around audit deletes and hard deletes of study data So in the Amber release, and the next few slides breaks up some of the key things we are targeting, so for RDC onsite, we are going to support partial SDV verification where you will be able to identify critical DCIs across the study and set an auto-select rate and count of initial patients and patients requiring 100 percent SDV in there Another feature we are adding and I will show you a preview is a single patient case look This is where we are working with our SDV patients, and this is an example of how we are working with our partners because they tell us that the single patient page look is the number one feature requested by the end users and this is exactly how it sounds, to see all the cases one patient at a time Then around the verified approval enhancements we will have the ability to have customizable inclusion/exclusion data, in the group verify dialogues and to focus on enhancements around retaining the verify approval status, an example of how maybe you are making a discrepancy update where today it causes the statuses to require re-verification approval in the future you have the ability to configure that where it will not change and provide additional productivity ON the TMS side we are going to provide enhanced drug coding with Who Drug format C and the enhancement in that area is the ability to pull in auxiliary information from ORACLE CLINICAL/RDC questions and present that in the customized VTL admissions screen and I will have a screenshot of that coming up Also for TMS we are looking to support the additional products mission, and although that is still a ways away we are in discussions with various regulatory agencies interested in potentially using the TMS as a maintenance for IDMP, so we want to be able to make any types of necessary changes or tests to support IDMP Then on the OC side I mentioned earlier that we are looking to support RACS, and to support RACS we need to have enhancements for PSUB and looking to store the .out and .log files in the database So also by being able to do that there is a particular failover it is not dependent on those files being in a specific node and enable support for failover and also we eliminate the requirement for having the OS level user accounts on the server Then another thing we found out when working with our SOPs is that the actual delete study information feature is used quite a bit in the system and so they wanted to have the ability to audit that information to augment those hard deletes so we will have new backup tables for that In terms of new technologies we will have multi browser support to make it more flexible if they can use Firefox, Chrome, or Safari for iOS, obviously that will be supporting on the ipad for data entry and monitoring activities I mentioned earlier about middleware and also in terms of the database level to upgrade from the 9i to the 11a optimizer The target technology slide here is a little bit out of date, I should have made some additional

changes here We will likely be targeting windows 8 as well for the Amber release as well as the new browsers listed there On the web server there will be windows 8 service pack 2, 11g for the forms, on the database side we will be supporting Solaris 10 and 11, oracle enterprise linux, windows SV8 2 and RAC At the minimum it will be 11.2.3 but we will also look at the 12c database as well In terms of the upgrade paths, because it is an AS11g middle tier it would be a new installation required and on the database we are looking to support direct upgrades from 4.0 to 4.66 up to Amber In the next few slides what I would like to do is give a preview, so for some of you folks who attended the sessions in Monte Carlo, but we did show some of these particular previews of new user interface components that we will take advantage of and I also want to show the single patient casebook and give a sense of the partial STV plan and then just show a quick screenshot of the auxiliary information and what the coding will look like In this first screenshot you will see that first of all some of the new fusion I you will have the ability to do things like one click icons for comment actions, and use the drop downs for the actions, also there will be link panels that can be collapsed or opened on the left hand side and the ability to shift and control click to select multiple rows to do activities on multiple rows of information What is really nice is instead of having to page through we have continuous scrolling and these are all things that will be really nice enhancements that will improve the overall experience A different view, this is the single patient casebook page which is a very highly sought after feature and I am very excited when I had a chance to see this One of the things I mentioned up front is that there is drill down links to go right to that patient and similar types of things like one click icons, scrollbars, what you are seeing is one patient, based upon whatever casebook is selected there are different visits going along the left hand side column for that visit to allow people to work on and review things This strategy is for improving productivity at the site This slide shows some new UI components that are going to be available, combo boxes, the interface will have in line messages, a pop up that was an error to guide the user, and also confirming information or messages in a popup as well Next when we move on to the next screenshot, which is a verification, so what we are also going to have is whoever is responsible for defining the SVT plans can come in and set it up here and specify who should be 100 percent SVT and manually select patients or import a list, or identify the critical CRFs that must be for all patients, so there are going to be two types, the patient and the CRF and you can use either or both and this screen here is intended to be both for reporting and defining Another quick shot within OC you will have the ability to maintain at the global library level and at the study level, to be able to set the default selections of what forms are targeted for partial STV and have a new column for STV there in the global library Then lastly, is related to TMS In the Amber release for TMS this is showing for classified emissions we see the auxiliary information which can be set up and passed over from the actual CR form to provide additional information and encoding to get very accurate coding of your drugs in TMS One of the things that I did mention earlier is we have the concept of also the ability to do VTI, whereas historically TMS has been able to code things consistently in a domain,

one of the things that a lot of people have been wanting to be able to do is to have the one off coding and be able to individualize coding for a particular term in TMS and this will be a VTI and as you expect a VTI would not be a synonym for auto-coding Moving onto the product roadmap here, obviously 4.6.2 was the last major release that we had back in 2011 and now walking through the key targets for the Amber release, the technology and the regulatory enhancements and some of the additional enhancements that we juts took a look at In the future we are looking to continue to start with the form level and then post Amber we are going to continue that at the field level so it is very similar in the approach that inform has taken, where they start at the form level and then go up to the field level In terms of other candidates that we are looking at, things like being able to have document attachments at the former field level in RDC and those could be things like images or any type of document or supportive information that you want to attach to a DCI We are always looking at the technology stack and ways we can stay current on it and also other areas of Linux on the middle tier, one of the other projects we have is around Siebel Sign On so that will filter through all the products shortly Then in productivity is single click copy study Companies have created template studies and they want to use single click copy study to copy everything from a study template and set up a new study very quickly The next two around study import/export and archiving, these are enhancements that are driven from the fact that a consulting organization has created an import/export functionality in the past which was available through 4.5.3 and is no longer available and there is a desire to support those features in the base product to import export between instances or a sponsor working with a CRO and with the more outsourcing to have more support for sending the library or the study start up or metadata, and various types of cases that have been identified in that area In terms of archival, getting information out and possibly get it back in, it is not entirely known how often that is done We always have requests for supporting industry standards like C-disk or Bridge, this has been on the backlog and not at the top of the priority list but are always looking at In terms of integrations we are always looking to be able to integrate ORACLE CLINICAL AND REMOTE DATA CPATURE with Argus or safety lists, and so this was just the key information that I wanted to share, with the Amber release and beyond that ES: Thanks Chris Before we move on to the Q&A I want to remind everyone that you can ask questions in the chat feature We will try to answer as many questions as we can So we will begin with the first question What is Oracle’s long term plan to enhance RDC versus inform? CH: Okay, I will take that one That question gets asked a lot in terms are we looking to enhance RDC and Inform in lock step and the answer is no because both products have development teams and customer bases and the histories are different, RDC started as a paper based system and became an EDC and Inform started as an EDC and we work closely and can leverage things when we can so when we had the desire to put in a partial STV we were able to shortcut a lot of those activities and we can add some things of what was being done in Inform if that makes sense for them ES: What is the release date for Amber and any timeline for the updates that follow? CH: Right now the target release date for Amber is 2/4/2014 ES: An Oracle employee said that phase forward is a strategic product for Oracle now Can you please comment? CH: Phase forward? ES: Some employees are saying it is more important than RDC, can you please address that? CH: The reality is that inform RDC, they are both products used in RD clinical suite and Inform is predominately SAS based and hosted by Oracle SAS based solution and it is our lead SAS data collection solution but ORACLE CLINICAL AND REMOTE DATA CPATURE is our lead on premise solution for data capture and paper hybrid studies The key thing is both products are very strategic products within our suite ES: Do you know if Oracle has a plan to provide e-source solutions?

CH: Well, we are always looking at ways to, if the question is around capturing information directly and we are looking at that, and there are challenges in that there are so many systems out there, and we envision that down the road there may be desire to have information go from the HR system to the data collection system ES: The next question is for Vicky You mentioned that there are accelerators available Can you explain what this is? VG: Yes, we have a number of accelerators, some would be our validation suite so that if somebody is implementing or upgrading their system it will include data requirements, traceability metrics executed to validate the system along with that some of those are the products we have developed for example Accel Account Manager which we have developed to help our customers have an easier way to set up and manage their clinical accounts That is for ORACLE CLINICAL AND REMOTE DATA CPATURE TMS and lots of time IT because backing accounts are required and required specific system access naturally all those requests have to go through Accel Account Manager and through the web front end, a support expert, something like that business group or in IT Along with that we have tools like Accel Copy This is a tool that will allow you to copy study from a production database to a test database, it brings in the global library so yu can troubleshoot an environment about that, so if that person has other questions I would be glad to follow up afterwards ES: Is it possible to upload a file in ORACLE CLINICAL AND REMOTE DATA CPATURE? CH: In regards to the document attachment feature, that is something we are looking at At the same time I know we have other partners that have actually built a document attachment feature so if they are interested in getting more details about that contact me ES: IS it possible to import an ODM file? CH: That is also something that is a candidate for the future, something that has been on our backlog for awhile but while it is not supported today it is something we are considering, if in the release cycle it gets prioritized high enough it could There has been a lot of interest from companies in importing or exporting the protocol design tool or sharing information between various instances using an ODM format The answer is not today but I am aware of partners that have done it, that work very closely with us and have done it as a customized solution ES: What is partial data source verification feature? CH: I guess if I wasn’t clear, it is a feature to be able to support these user risk based monitoring guidance from regulators who that within RDC you will be able to define what the STV plan is so you can specific for example a sampling rate up front where 20 patients will get 100 percent STV and you want to decrease that, and you can also say I want 100 percent of particular forms to be done It is to support the trend away from 100 percent SVT and now in the system they can define the rules and monitor going in which ones or forms have been identified to perform STV on ES: Is there an upgrade path for various prior versions such as 4.5.3 to Amber? CH: There are currently upgrade paths from 4.3 to 4.6 so the recommendation would be to first 4.5.3 to an intermediate level to 5.0 ES: Great, the next question is we are just now upgrading to 4.6.x and are considering retaining 4.5.3 can you tell me what support will be available for 4.5.3 in the future? CH: I will say that 4.5.3 or really 4.5.x since it is 4.5.1/2/3 they went into sustaining support as of September of last year so we gave actual notifications and alerts to customers giving them a heads up that 4.5.x is entering sustaining support and once it is off of sustaining support there will not be any new patches or fixes, you can call and get help but it

is entitled to existing fixes but there will not be any new ones ES: Will you make standard sustaining summary reports available on default like demographics and compliance and AEs CH: That is not something that we have slated for the Amber release, we have received enhancement requests so it is something we can consider for post-Amber ES: With Amber, does it have a functionality to ease the migration of data whenever we have amendments? CH: Can you repeat that? ES: With Amber, does it have a functionality to ease the migration of data whenever we have amendments? CH: to ease the migration of data? I guess I would need to have a better understanding of the current problems they are having in performing a protocol amendment ES: Are there any plans to enhance branching functionality? For example, branching does not work on RQG CH: At the moment we do not have it planned in the Amber release This is something we can look at possibly for Post Amber ES: What are your plans for Cdisk bridge integration? CH: So one of the things is there are some companies that want to import, let’s say, protocol definitions from a protocol design tool into OC and then other companies have had requests to export to OCM to feed into their reporting and dashboards and analytics tools and those are some of the key use cases Something that I have mentioned is that one of the things is that ORACLE CLINICAL AND REMOTE DATA CPATURE, the data model does not match up directly to C disk model, the fact that we have the DCI DCM question group layer there, it does not perfectly match up so if you were to take an approach of supporting it we would have to come up with a particular import or export that would be able to match up what is coming in or being exported out So those are some of the key use cases still on our backlog as something to consider ES: I will ask another two more questions How can I make an informed decision on the purchase of RDC or Inform? Is there more information comparing the systems on the Oracle website? CH: I don’t think that there is a comparison between the two systems but our solutions consulting team and the account managing team have gone into various accounts to present both so they will bring an Informed sales consultant and an RDC sales consultant and they are on the same team and can talk about both, the capabilities of both and ask what are the needs of your company to know what makes most sense for you You can reach out through BioPharm or me and I will provide the account manager responsible

for your region to help you make that decision ES: The final question is how do informed customers compare to RDC customers number wise? CH: I do not have information on the number of Inform customers there are I know that on the OC side, how many we have but I do not know how that compares to be honest ES: It looks like we have used up our allotted time We did not get through all the questions but we will reach out to you and answer any questions that you have If you have any mor please feel free to contact us Currently we have Vicky Green in charge of our North America and Rudolf Coetzee in Europe so you can contact us at [email protected] You can also email Chris if you have any questions

Thank you for your participation and we hope that the information was helpful Have a great rest of the day and evening