Oracle AERS vs. Argus Safety

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Oracle AERS vs. Argus Safety

Hello everyone. Thank you for your patience and welcome to the webinar titled Migrating from Oracle AERS to Argus Safety: Reasons for the Move presented by Perficient’s Dr Rodney Lemery, Director of Safety and Pharmacovigilance I’m Eugene Sefanov, the marketing manager for Perficient’s Life Sciences practice and before I turn it over to Rodney, I’d like to go over some housekeeping items During the presentation, all participants will be in listen-only mode. However, you may submit questions to the speaker at any time today by typing them in the chat feature located on the left side of your screen Please state your questions clearly and keep in mind, other webinar participants will not see your questions or comments. Nonetheless, your questions to the speaker will be addressed as time allows towards the end of the presentation If you still have unanswered questions after the webinar, or would like to request information about our services, feel free to use the contact information on the various slides throughout the presentation. You can also fill out the contact form on the Life Sciences section of Perficient’s website. Please note that today’s webinar is being recorded and will be sent to within 24 hours. A link to the PDF version of the presentation will also be included This concludes our housekeeping items. I would now like to turn the call over to Dr. Rodney Lemery Good morning or afternoon or even the evening, depending on where you are joining us. Thank you for joining us on our webinar today I just wanted to take a few moments to explain who Perficient is. We are a large, now global, a consulting firm focusing on information technologies. And, as Eugene state earlier, this being sponsored the Life Science team here at Perficient. We’ve been in business for quite some time. We are a public company and have around 2100 colleagues worldwide We focus on business solutions as well as technology solutions around a very large, robust, diversified portfolio. And, again, as Eugene stated, we are the Life Science team at Perficient, focusing on clinical and pharmacovigilance applications and business expertise So, we have, within the Life Sciences, a Clinical Trial Management Space, a Clinical Data Management and an Electronic Data Capture space. The team that is part of my group which is the safety and pharmacovigilance team, and finally a Clinical Data Warehousing and Analytics team We have a wide portfolio of services that we offer within those 4 arms, within the Life Sciences and again, I head the safety and pharmacovigilance team here at Perficient So, I’m sure you all registered for this and know what you’re getting into, but I wanted to take a few minutes to discuss with you all some of the things that we’ve seen over the past many years working with both the Oracle AERS application and the Oracle Argus application I’ve taken the time to provide screen shots that show some very stark differences between the two applications and we will spend some time going into the reasons that people might want to contemplate migrating off the Oracle AERS platform and onto the Oracle Argus platform I’m going to focus the discussion basically on two aspects of this system: usability from a business user’s perspective and usability from the administrative perspective I recognize that this lecture is pretty focused just on the business view, leaving out the IT view altogether. In the end of the slides, I will attempt to remedy that bias and talk a little bit about the technology differences between the AERS and the Argus application, which also may be a reason for migrating off of the AERS application and onto the Argus system So, this outline here will show you all of the aspects of the application that are just a very large noticeable difference between the two systems. These are not comprehensive and I should also mention that many of these slides, while I tried to be factual as much as possible, do rely on some subjective analysis as well

So, I’m basing that off of my team’s experience between the two applications and also our clients’ perspective of those two applications over the past many years working with both of them So, I’d like to start by looking at just the business side usability of the system and there are a number of stark differences when we look at AERS and Argus applications The first, we’ll focus on being just general case management, graphical user interface differences. There are a number of contrasting of the AERS application and the Argus application There’s some very noticeable differences in the two systems’ ability to perform medical and drug coding. And, we will look at those as well Argus, and again, remember the objective this morning that I gave, arguably has an improved Document Management capability within the native application. It, for example, can out-of-the-box, integrate with documentation and many times I hear not only from my team members, but also those we service, that the attachments within Argus are far easier to maintain We’ll also look at the expedited report tracking capability. So, these are the individual case safety reports and how the two screens differ within the applications The medical review window, which is very special to Argus, and to be very honest, is the key selling feature of the application when we do demos or potential pre-sale calls with clients. So, we will, we will look at that aspect We’ll also look at the E2B support. The Argus application has a very nice tracking mechanism built into the application so that users may track their electronic submissions and we, this becomes very important for global companies where non-FDA regulatory authorities have for many years now, required the electronic submission of individual case safety reports And, now, as we look at the final update rule from the FDA post-marketed surveillance cases as of June 10th, I believe, 2015, will be required for the FDA for anyone doing post-marketed safety. So, this, each of these mechanisms becomes quite important for a safety software to accommodate. And, again, arguably, Argus has a dedicated methodology to, to tracking and submitting these things unlike the AERS application We’ll also take a peek at some of the dashboards that come with the Argus application, which again, very different than the AERS application Arguably, Argus comes with an integration to the Oracle Discoverer Tool. We will see some ad hoc listing and tabulation capability with the Argus application in this discussion and how those compare and contrast with the Discoverer Tool We’ll also look to a very unique component of the Argus application that simply doesn’t exist in the AERS application without some heavy configuration called Worklists and worklists are a way that people can keep track of all of the case management workload that they have assigned to them throughout their work week, month, year And, also, Argus J. Argus-J is now integrated fully with the English version of Argus and there are some very interesting features and functionality of Argus J that simply are not available in the Japanese Kanji enabled view of AERS So, again, keeping in mind the subject warning that I gave prior, we have heard over time that the general interfacing between the AERS application and the Argus application are quite different. And, as a former AERS user, I can just give my opinion on that and I do agree with that It is a little easier to navigate through the Argus application, the fields are ordered in a more clinically intuitive manner. The tabs along the top of the case management screen in Argus are fewer in number than the tabs along the, the AERS application

Some information that you would expect to see in centralized screens in AERS are actually duplicated across two other tabs or more And, this sometimes causes confusion. This type of field duplication just does not occur in the Argus application So, again, in general and in opinion format, there are fewer tabs, the fields are a little more structured and well organized in the Argus application. And, again, remember, objective opinions here One of the key features of a safety system is to actually enable and empower the case managers to perform their required assessments between the events and the various products that are administered to the patient or to the participant I should say Here, we can see the screen from Oracle AERS This shows you all of the product names and the individual event that needs to be assessed against each of these suspect products. The screen is integral, it’s understandable, it’s just a little busy and probably could have been a little more intuitively built This, again, is all opinion, but if you look at the Argus application screen that, that performs the same functionality as AERS application screen, I believe you’ll note that the Argus application is far more intuitive. There’s color coding, as one of my technical team members pointed out, and this goes to the IT differences between the two, AERS is built on an older Oracle form technology platform and Argus is utilizing a wide variety of other software, but most ASP pages which give this additional look and feel that has some technical capabilities that the Oracle form technology simply lack So, there is some definite increased ease of use, if you will, between the two systems The other important point here is that many times users will need to go down to what we call local labeling within the events, product assessment screen to look at all of the places in the world this particular product is marketed and we’ll often times want to be able to control the listedness at that level The Oracle AERS application accommodates this, but with a drill down. So, there’s a drill down for local unexpectedness and a rather complex screen appears showing you all of the marketed licenses for this particular product and then allows you to place your anticipatedness or expectedness into the appropriate field In the Argus application, it is the exact same screen that we were looking at before, you simply click on the plus sign for the licenses and the individual licenses expand down below giving the user the ability to code the local labeling So, again, I would argue that this is easier to interface, no drill down, it’s right in front of you. Which can also have an effect on the speed in which cases are entered and managed Argus has some unique characteristics that AERS doesn’t even have. So, the first would be a type ahead feature. This will allow you to type a letter and if the field is linked to a drop down or a list of values, then the list of values will automatically display and show you the various values that meet criteria So, in this case, anything in that list of values that starts with the letter S. So, again, just a stark difference between the Argus application and AERS One of the really nice features of the Argus is that you can quickly go back to any of the cases that you last accessed. So there’s a menu selection and I can look back at any of the various cases that I have previously been working on Along that same line, is a very, very distinct feature that we hear all the time that people want in Oracle AERS and that is the ability to have multiple cases open simultaneously Now, Argus can accommodate this, though it is important to note that even in Argus, you will not be able to pull open the case entry form for both of these cases simultaneously

But, you can toggle between the various cases you have open at any given time. And, that, again, is also from the active cases menu path, but now your active cases show as numbers above the last accessed case So, this is a large improvement from the AERS application, and, honestly, it is a, a feature that we hear that people want in Oracle AERS frequently There are some VERY big differences between the coding systems used between the AERS application and the Argus application and this might get into a little bit of technical discussion, but first I just want to show you the usability So, the top screen shows you the AERS application for an included verbatim term So, in the AERS application as it is integrated tightly with the TMS system out-of-the-box, it will pull open the TMS interface and ask the user to locate the medical term in the MedDRA dictionary and gives them the ability to classify or code the medical term Argus has an arguably has a far simpler integration to the dictionaries and as a result, is a little more intuitive to locate and find the appropriate LOT that you’re trying to code your medical term to Similarly, when integrated into the WHO Drug dictionary for drug coding, again, the drugs are coded in the AERS application against the TMS systems. So, the same TMS coding window appears and the users are asked to query the TMS repository for drug terms that are present in the WHO Drug dictionary. There are some mechanisms in loading the WHO Drug data into TMS that have been accommodated through WHO, et cetera, and it causes some awkward data to appear in the WHO Drug dictionary values Things like what you’re seeing on the screen, the Tylenol PM with let’s say a drug record number after it This does not happen in the Argus application as it will split out, especially if you load the feed (?) format, it will split out the medical drug codes into separate lines, each one representing, for example, a different ATC code and it facilitates the picking of the appropriate, in this case, aspirin term based on the clinical information that the case manager has in-house So, there are some definite improvements in the visibility of the data between the two systems and also, jut again, the usability Additionally, in Argus, we have a really nice feature where at any point we can locate a case and access that case’s coding review screen, which will give us a single screen that shows us all of the medical terms that have been coded or needing to be coded and we can perform all of that coding right from the central screen just as though we has opened up the case and gone to the events tab So, this is a very interesting way to accommodate a central coding group who may be responsible for coding multiple cases at the same time And, it’s also just a nicer way to view the case data when you have your coding hat on I should mention that Argus out-of-the-box is not integrated with a complex dictionary management system such as TMS or DS navigator and this result really in the far less complexity of the dictionary management side of things So, this slide is a little technical, but the recoding efforts and the dictionary reversing efforts that are involved in TMS are far more complex than the default capabilities of Argus And, just to kind of emphasize that, in, within our team at Perficient, we have certain people that can do TMS dictionary versioning and no one else can really do that. And then,

for Argus dictionary versioning, anyone on the safety team, the safety or Pharmacovigilance team has been trained and can perform that type of work as it is far, far less complex This may translate into a bit of cost savings for a particular company in terms of personnel being hired or the involvement of third party vendors to perform the work on your paths So, you simply don’t need those things when you are using the dictionary management tools that are inherent in the Argus application Just to note, the Argus application can naturally integrate to DS Navigator out-of-the-box and there are install instructions to show how doing that. It’s important to also note that it can integrate to ANY external dictionary management tool using web services, TMS is one of those options So, now let’s take a brief second and look at the ability to attach records to the case This is an important aspect of case management work processes. Usually, we would be attaching the source documents here, be it a discharge summary report, a hospitalization record of some kind, patient laboratory records, it could be anything, it depends on the type of case The originating literature article, for example In this example, I’m showing how very easy it is to attach files in the Argus application So, there is a button on the additional information’s main tab. It’s attached file. When you click it, it opens up a window, an inherent window, it looks like a Windows browsing application So, it’s very intuitive to anyone who’s been using a Windows machine. You click the browse button and then you can locate your source file, in this case, an MRI result on your desktop or file share, et cetera, and then you click open And, this now, once we go back and click okay, will natively be stored right with the case data and you can see that here in this record I’m able to give a description of the attachment, keywords so that I can search on this latest one and I can even classify this as a particular source document or a, in the case of E2B transmissions, sometimes the files will need to be routed, submitted with the E2B and we can classify this as a E2B attachment file Here you can see if I just click on the JPEG image here, it opens up a separate window and it actually shows me the MRI window right here on this screen. It should also be noted that it does natively integrate with document desk so if you wanted a more robust or advanced document management system, Argus can comply with that as well If we contrast this to the AERS application, the Portal technology is what is used to house all of these folders and images and while we can create these things from the AERS interface, it’s still very, and this is still an argument, it’s still very complex and takes a little bit of technical knowledge and a lot of user training in order to, to get the attachments where they need to be There’s also a wonderful key selling piece of the Argus application called the Medical Review screen. And, much like the coding screen, this Medical review screen will display the case in a central window and allow a medical reviewer to see all of the key data points that he or she would use when assessing the case from a medical perspective So, here you can see on the medical review tab within this window, I see the narrative in this case, I see any case comments or specific company comments, I see all of the case level comments, I see the individual event level assessments And, it’s important to note that this is not just a review window, I am able to make modifications to the information here as the medical reviewer One of the beautiful things about this on the temporal view tab, I am able to clearly see the all of the concomitant therapies, past medical history, laboratory dates, suspect

medications and event dates and now I can clearly see a small histogram showing me the date and duration of the, between the event and the suspect product and I can actually confirm whether the event was indeed treatment emergent So, this temporal view, if you checked with a number of your medical reviewers, I suspect that you would find that they are doing something similar to this on pieces of paper when you give them the Med Launch to review, because answering the question was the event treatment emergent is kind of vague, a very big clue into looking a relationships between product and event So, some type of drawing or, or visual record of treatment emergent information is probably being used by your medical reviewers. So this temporal view actually accommodates that right within the application And, again, we don’t have anything like this in the AERS application Additionally, from the medical review screen, I can catch and view source files and I can also run any of the individual case safety reports that come with the Argus application and there are many, many of them So, I can run all of these right here in draft mode. This facilitates the ability for some of your medical reviewers who prefer paper to still open up a med watch and perform the medical review right from the med watch report And, this is, again, a very key feature and difference the AERS and Argus application So, let’s look at a minute at the regulatory report tracking for individual case safety reports between the two systems. So, then, what you will see is that the two screens are very similar in nature. And, again, this becomes a subjective opinion. But, one of the things that I hear when talking to people who’ve used both applications, is that the Argus application is far more simplistic in its view So, in the Argus application you’ll see folder structures in the upper part of this block This will allow you to fill tips, so you can out down to the country, click on the country and the lower screen will automatically update and show you only those reports from that regulatory authority This is opposite in the AERS application, but similar in nature. Now, again, we’re seeing technology stack difference here because we are using a far more flexible and up-to-date technology in the AERS application, sorry, in the Argus application called ASP, we’re able to get graphical, visualized objects that are a little more intuitive to navigate than the old Oracle forms technology that you’re seeing in the AERS application So, again, here’s the filter in the AERS application and here’s the filter settings in the Argus application. I think it is very much an appropriate argument to say that it is a lot more intuitive in Argus than in AERS Even just the simple running of reports is very different between the AERS and the Argus application. So, you can see here in the AERS application, we have a quick report screen that is showing us all of the parameters that needs to be entered in order to run the report Many of the clients that we have that utilized Oracle AERS Siebel with the construct of case version status and back, and back report options So, the back report version and the case status report are, are two very complicated concepts for people running AERS standard report. In Argus, the parameters are far more intuitive and they match all of the list of values that you’re users are already familiar with from the case management files So, again, the argument is that it is easier to run basic reports in the Argus application as well Now, from the usability side, the last thing I would like to show you is actually the E2B

transmission screen in Argus, which is a, what we’ll call a worklist. And, when you go here, you’ll see that very clearly we can see where the E2B report is along the transmission process We can see any problems that come up, they are colored coded red or yellow, and we can see the error messages or warning messages that are associated with those color coded differences This is a very key and important distinction between the AERS and the Argus applications The E2B transmission is only going to become more and more important as regulations shift and change in the world around us. So, having an intuitive E2B screen is a pretty big requirement in most of our implementation projects Finally, I’d like to show you some of the dashboards that are available in the Argus application that we don’t really have in the AERS application at all. You could arguably build these in Oracle Discoverer, but that would take a trained Discoverer person and would likely require an additional Discoverer administration license because the end user layer that comes with the AERS Discoverer tool application often doesn’t have the, all of the required fields that would be needed to perform some of these complex reports So, here you can see it, these are all built into the Argus application. This is an expedited report status screen. You can see color coding in this and the screens are interactive So, for example, if I wanted to drill down into these cases to see exactly why they were late reports, I could double click on them It would take me to a worklist, and then I could clearly see what happened with the individual cases So, again, these type of intuitive dashboard type reports do not come with the AERS application out-of-the-box You can also create ad hoc line listing and tabulation and graphical reports from AERS, um, Argus, directly using the aggregate report area. Now, I will just mention that the graphical reports are, are a little cumbersome in Argus because the key often overlay the actual graphics itself So, just in the spirit of full disclosure, I wanted to, to give you that information However, consider that this is not an additional reporting tool, it does not require additional licensing and the interfaces are fairly intuitive, it is a very, in my opinion, very large benefit of the Argus application when compared to AERS Anyone who has used the Discoverer tool can tell you that it does take some training, it takes some understanding, especially if you want to do complex reports. But, here, the ad hoc line listing reports and tabulations are very useful within the, the Argue app Let’s talk a bit about worklists. I’m only going to focus on two of them right now, for the purpose of our talk. That’s worklist new and worklist open. The worklist new is an interface within the Argus application that will allow you to visualize all the cases that have not yet been assigned to an individual or a workflow group for which the user that has logged in has access And, this is an important note because we don’t really have anything like this in the AERS application. In a moment, I will show you the closest thing we have which are what AERS calls inbox queries But, unlike those queries, which have to be programmed and built sometimes by advanced users in AERS, the Argus application natively integrates with the underlying workflow. So, each time a case is passed along a workflow desk, it returns to the worklist new area and waits for the next person in the workflow to pick it up and use it The worklist open is very similar to worklist new, except that it shows me all of the cases that have already been assigned to either a user or group. And, this empowers a company to deal with sickness, if someone is out sick for the day and I need to take over their cases, if we are both part of the same workflow group, I’m capable of, of seeing their work and picking it up and working with it so, that regulatory timelines are not damaged

Again, the closest thing we have in AERS are the inbox queries. It is theoretically possible for us to create inbox queries that would integrate themselves to a user’s permissions, studies and workflow group in AERS. But, I would argue that that query would be extremely complex and certainly not something that a standard case management safety person would be comfortable doing So, again, just a stark difference between the two applications So, lastly, we’re just going to look in terms of usability, at the Argus-J interface and one of the main key differences between the Kanji version of AERS and the Japanese version of Argus and that is this split screen data entry capability So, in Argus-J, unlike the Japanese version of AERS, we’re able to pull open the case Japanese and then with a click of the button, we can display the corresponding English information on a split screen and this very helpful especially if you have people who are non-native speakers or you just want to simply understand more about the Japanese interface and you don’t read Kanji Another key difference in the Japanese version of Argus-J is the accommodation of what Japan calls the Japan Pharmaceutical Information Center or JAPIC. JAPIC is an organization that scours the research articles in Japan for any potential cases of adverse reactions and stores those articles and potential cases in a dataset and that dataset is available for purchase And, in Argus Japan version only, there is a functionality to actually upload JAPIC files into Argus Japan, and then it will allow a Japanese user to scour through those articles visually and locate potential findings that should be cases So, for example, they can load the JAPIC information into the initial screen and then with click the button, decide which of those articles should or should not create corresponding cases in Argus-J This is very helpful due to the PMDA regulations around literature searching that are very different in Japan when compared to the rest of the world So, that’s pretty much the information around usability. And, again, I just want to make sure that you understand that that is subjective And, now I would like to look at just a few differences in terms of administration between the two systems We’re going to look at user defined fields How the two systems accommodate this and why, arguably, Argus is a little simpler. We’ll look at basic code lists and some of the differences between the two systems and how complex and non-complex Argus is compared to AERS We’ll look at the expedited reporting role and periodic report maintenance and execution differences. And, we’ll also look at Argus’ ability to natively integrate to your LDAP server with really no additional software So, let’s first look at how to create a user defined field in Oracle AERS. Well, any of you who have done it, know that you first have to first access the flat configuration, you have to locate the custom field that’s Oracle. And then, this is the part that always frustrated most people we work with, you have to look at previous fields, find the x, y coordinates and then adjust your custom fields x, y coordinates accordingly, keeping in mind the hyphen with unique view So, this is definitely not intuitive. I, I would not argue that this is an intuitive chain. I think it takes training. It takes practice. And, certainly, that all comes with an internal cost to your organization If we juxtapose this with the actual methodology used in Argus, we will see that it is far, far simpler. And, would likely result in a huge cost savings. We can activate user defined

fields in a second, this is simply not true in AERS So, in Argus, for example, you access the field label are from Argus console, which is the main configuration area. It’s essentially the global configuration area of ARES. And, when you look at the field, the tab that you want to activate and additional field on, you would see that there are already pre-populated and they come in dates, number and text mode values or types, and you just click the appropriate value or type that want to activate, whether it’s a date, a number or text as they also have character to object fields So, you can activate these. Now, of course, like everything in life, things that are a little less complicated mean that you have to deal with some limitations. So, while it is far less to activate these user defined fields, one of the downsides is that you have absolutely no control where that field appears Be it, the field appears in the same place always and you cannot modify that without customization So, this is one of the drawbacks that I would still argue that the amount of time you’re saving in enabling these user defined fields is still a very large benefit between the two applications The code list maintenance is also a key piece of difference here. We have the AERS application which has the complicated language values that have to be adhered to and these, and this is the toggle code list in AERS and here you can see the exact same toggle code list in Argus it’s far easier to maintain these code lists in the Argus application The underlying complexity of E2B transmission, for example, is all held in the interchange system of Argus The regulatory reporting rules in AERS are limited in the configuration. You have specific conditions syntax that you have used and specific operators. Now, you can get very clever with these, but they are not intuitive and they are a bit convoluted to remember and learn This is very different from the Argus application where all of the parameters if you will for configuring the global regulatory reporting rules are very clearly identified on the screen, you can see those here, and then in addition, we have this really fascinating capability which is used quite frequently, especially by large companies, the advanced conditions, which allows us to really to focus these expedited reporting roles on very clear, specific attributes within the case data. So, this is a definite benefit between the AERS and the Argus Application For periodic reporting, and for anyone who has done in Oracle AERS can tell you the concepts to the end’s convoluted nature in the printing and tracking periodic reports within AERS With Argus, it is far easier. We have a central screen that we go to actually create and generate periodic reports within the application itself We can generate those periodic reports and track their specific mission all within a particular screen. One of the benefits in louder versions of Argus is that the submission and generation of these periodic reports, which can be very large and could slow down your database and you may take a performance hit, have now been offloaded onto the application server or report server so that now you will now not see a drag on the performance of the application And, so this is a very nice additional feature of the Argus application compared to AERS We also see that the Argus application, unlike AERs, can integrate to your LDAP server very, very easily. We’ve, for example, had recent clients come to us and ask how do I change, I have a new LDAP server, I need to reconfigure Argus, but I’m not sure how and we’re, we’re concerned that it’s going to be very complicated But, realistically, it actually is not. You have a single screen and you just have to make sure you set the parameters appropriately

So, again, to kind of summarize, in general, and again, subjectively, the user interface between the Argus and the AERS application are far more simplified in Argus. This likely translates to usability improvements which then would give you, potentially, a higher compliance rate within terms of regulatory reporting and case management in general Again, subjective and opinion, but this is our practical and empirical evidence that we’ve observed over time We have ad hoc reporting built in the Argus tools. It does not require additional licenses nor know how to execute these report and there is a level of configuration, administration is that potentially could allow the safety team to operate, maintain their own safety system compared to Oracle AERS, where an IT or a business IT savvy user really has to be involved in every aspect of configuration I also wanted to note that there are some additional considerations that we didn’t cover in this slide deck that you would also want to look at when deciding to migrate from AERS to Argus. And, this may be a good idea for you and it may not be a good idea for you So, you really need to take a look at all of the benefits that you seek from the usability side and weigh those against some of the drawbacks, such as licensing costs. There are differences between the AERS license costs and the Argus license costs You will also want to look at total cost of ownership. So, this would mean looking at the two systems and their server costs. Any supplemental software that is required to run the two, for example, Adobe. Most of them can run with just Adobe reader But, Microsoft products are required for the Argus application, so what do those licenses like. You know all of these things need to be factored indecision. You also need to look at data migration costs and complexity with the method that you’re using for the data migration And, also, an important point is the software license fee. So, for example, we know from our presentations that Oracle has made, that future enhancement of the AERS application is going to be very focused on the regulatory authority use of the application and might not include the necessarily functionality from the perspective as a bio-pharmaceutical or medical device company. This may have an effect on your decision. You need to take that into your decision making capability And, for technology support limitations, you have to think about that. There are certain operating systems that are required between the two applications and those are definitely things that need to be considered when deciding whether to migrate off of AERS and onto Argus So, I think at this point, we will open it up for any questions that people may have Thank you Rodney. Feel free to ask your questions via the chat feature. And, we’ll give it about a minute or so for, or to see if we have any questions And, in the mean time, I’ll show our contact slide if you’d like more information, you can always reach out to Rodney or you can email our general [email protected] You can also reach us at one of the phone numbers depending on where you are in the Okay, Rodney, do you want to take this question? Sure. So, I see, I see a question: Where does Oracle Argus stand in terms of features, feature comparison with its closest competitor? And, then, a follow up question which is: Who is the probable closest competitor? So, I will just generally answer that. Other than comparing Oracle AERS to Oracle Argus here, the closest competitor per se, is probably would be Argus applicable. It’s obviously

Aris Global, ArisG. That is a whole talk for another webinar, so I can’t get into that there in terms of how does it compare to its closest competitor And, again, lots of subjectivity in that, in that particular question So, sorry if that was a cop-out answer, but it’s really difficult to answer that without going into some greater detail If there is an interest in another question: Is there another system that you are aware of that will be the next system? I say, e.g after Argus or is Argus the now the gold standard for the next foreseeable future? So, that’s a very good question. One that was asked considerably, at least last year’s Oracle health sciences user group and I would say that, from my perspective, the answers that we got from Oracle were very clear. That Argus is the premiere individual case safety management software for Oracle in terms of bio-pharmaceutical and medical device firms From a regulatory perspective, that individual safety case reporting tool is AERS Rodney, do you want to take the next question? Yes, I see the next question, it’s” in AERS, we can submit multiple reports, but in Argus, we cannot submit other reports unless your first report completes. Is parallel reporting processing going to be added to Argus in later versions? So, I must admit, I’m a little confused by the question, but that’s probably just me So, let me take a minute to reread it Yeah, I’m not sure if this is in regards to individual case safety reporting or in terms of periodic reporting. I will say I don’t know what version of Argus you’re working on either, but in later versions of Argus, then, for periodic reports that you are off-loading those onto the report server and so it is possible to submit multiple reports simultaneously that will queue out and then they will run in order of execution If you were talking about individual case safety reporting, why don’t we take that offline and I can give you more information and respond to you then Okay, we’ll give it another minute, or thirty seconds for additional questions Okay, looks like we don’t have any more questions, so that will end our Q&A session. So, if you do have additional questions after the webinar takes, please feel free to contact us Please note that today’s recording of the webinar will be sent to you within 24 hours for you to review and share with your colleagues We’d like to thank you for your participation and hope that the information we provided you with today was helpful. Feel free to join us for our upcoming webinars, which can be found on Perficient’s website Thank you so much for joining. Have a great rest of the day and evening Thank you everyone