Mastering streamlined, compliant research
Welcome, everyone, and thanks for tuning in to our Insights Boot Camp webinar today. If you want to learn more about how to streamline your market research and achieving a hundred percent compliance, you are joining the right session. My name is Tanja Kratz de Suarez. I’m a product marketing manager here at MarketLogic and your host for today’s session. I’m also joined by my colleague and expert in customer onboarding, Sabrina Bushman. She will be leading and guiding us through the demo part, later in the session. One quick note on housekeeping before we get started. We are recording the session, and we will be sharing a link with you, as a follow-up so you can access and stream at any time of your convenience. We also reserved some time at the end of this, session for addressing some questions. So please feel free to, share them here in the chat box on your on twenty four screen. Before we jump right into today’s topic, I do wanna say a few words on who we are. MarketLogic provides leading brands with insights management solutions to help them on their journey to becoming insights driven. Marketers and insights professional professionals really use our AI enabled platform to easily access their vast knowledge and state of insights, develop new insights, and also share and socialize insights to make sure they’re really being used to inform business decision making. We’ve been around for over fifteen years now, and in this time, we’ve helped more than a hundred global brands on their journey to becoming insights driven. And among them are leaders such as Unilever, Vodafone, and Tesco. Now in health care and pharma, we know that compliance is not a compromise. It’s an absolute must. And market research is a huge investment that needs to be managed well to minimize financial and reputational risks. Now pharmacovigilance and government regulations make market research very complex and lengthy. That’s why we build a solution that is specifically tailored to the needs of health care and pharma enterprise insights teams. So our goal is to really reduce complexity, you know, reduce the delays, to deliver your research and to take up some of this heavy administrative work of the insights managers. You see some of the brands, that we work with here on the screen. And, before we dive deeper into the solutions that help those brands in streamlining, their research and becoming compliant, we’ll first take a look at some of the challenges those organizations fail, face oftentimes before they move to market logic. So we oftentimes hear that the current processes are very frustrating because they, include a lot of manual task, a lot of manual setup, which increases the risks of inaccuracy, inconsistency, and also noncompliance. Fragmented processes really result in a lot of time wasted because insights managers chase their stakeholders, you know, they chase for deliverables. Another very common challenge is, with having multiple systems in place. This is really making the collection and gathering of information very cumbersome because information is just scattered across different systems. Now, what can organizations do to really overcome those challenges? So one of the solutions are flexible and automated work streams workflows because they really help to lower these manual work for insights managers while at the same time addressing compliance requirements of the businesses. Yeah. So steps within these, workflows, they really can be tailored to reflect the standard operating procedures and best practices. Another solution is a smart approval engine together with automatic reminders. Will these really help to align all stakeholders, online? Again, this is a way to speed up the process because it does remove these extra steps of chasing, stakeholders and really chasing deliverables. And probably one of the most important aspects is here also really having one unified system. Yeah. That makes it easier to access all the necessary documents, rules, and guidelines all in one place. It also makes, the compliance reporting much easier source of truth that really houses all the relevant information and documentation. And this is really where MarketLogic’s research management, toolbox can support. It does provide an end to end solution with configurable workflows, a smart approval engine, automatic automated, compliance reporting all in one tool. Now we’re gonna now use the next minutes to show you some of those smart features live in the system, and we will, yeah, walk you through a process and project that you can follow along. And the first key feature that we wanna zoom in on is adaptable workflows. Now these really, you know, take up some of those mental loads for the, for the insights managers because we can set up workflows that are tailored to the specific needs of a research process. It also helps with streamlining and standardizing those tasks and setups. So it really helps to, you know, increase productivity and speed up timelines. It’s it’s also fostering collaboration efforts because it ensures that everyone involved in the project is on the same page, has access to the information that they need, and has ex access to the right steps within the workflow. But let’s actually have a look how this looks live in the software. And, for that, I will hand it over to you, Sabrina. Thank you so much, Tanja. Yes. Let me go ahead and share my screen. And I’m, very excited that I get to show you around exactly what what Tanja was was mentioning earlier. Joe, essentially, what we’re trying to do here is we’re trying to to to work with your framework, set up adaptable workflows, and in the end, save you as much time as possible, take away complexity, simplify the workflow. And yeah, as Tanja mentioned, not only save you time, but more importantly, save your insights managers time. We not only do this when when they’re required maybe to to fill in actual content or give information. We do have a solution for that, but maybe more importantly and and Tanja has said said this. This is about, yeah, reducing maybe the mental load, of the insights managers, especially when it comes to compliance requirements, when it comes to what to document, where, when, who to pull in, at what point in time, and all of this, I just wanted to show you in the next minutes. Now I have a project prepare pre prepared here for you, but I did want to mention that, yeah, before we even rolling this out, we’re launching it to your insights managers. We’re gonna sit down with you, and we’re gonna define those workflows. We’re going to make sure that your frameworks ways of working are reflected in the system and we can set up templates. Those templates can differ, of course, from project type to region to methodology, and they’re meant not only to give the insights managers the right fields at the right time, but they also allow you to automatically pre populate content. Let me open my example project here and you can see we can pre populate, for example, the project team. Who needs to be informed? Who needs to be invited? We have milestones and tasks that we can set up. And those can be automatically assigned to the right person. They can have a deadline in here. When it comes to those milestones, it might also be important to know that, of course, we can we can set up action based notifications. I was speaking about this earlier. Compliance requirements also always mean that you need to, yeah, really comply with all of the interdependencies. And if you have, for example, looking at this list here, you have everything ready. Your project would be already completed. You can publish it but you’re still waiting for let’s say the AE reconciliation form that the supplier would upload. What happens is the system automatically informs, notifies the supplier that that is still outstanding when the deadline is. And then once the point is completed over here, it will also automatically send a notification to you Joe that or to your insights manager so that you now know, okay, everything can progress as planned. All of this, again, really designed to to, yeah, make sure that people responsible for conducting the research, for making sure the right information reaches the organization at the right time do not have to spend too much, yeah, thinking capacity on deadlines and on little steps so that everything is set up in a, yeah, quite bulletproof way, always complying with your compliance requirements. Now we talked a little bit the about the the templates that we can set up, the milestones, the action based notifications. I also wanna point out here at the top of the project, we essentially have the different stages, the phases of the project that give you a little bit of a visual guidance as well Joe that, yeah, insights managers can easily follow along what is next. And, of course, even within those phases or steps, you would see that the the the the way that we set up how the project is is designed, what it looks like, and when to input what information is very much based on a question based guidance. So it does not require the insights manager to always have every little step at top of mind. Instead, we are going to ask them here little questions and then based on their answer, based on where will the research be conducted. For example, there might be an additional field that shows up. So we have here a lot of the questions set up to trigger new fields or to even remove steps really just by simply following the questions that are available. I just wanted to show you an example of this. If here in our case, it is not always clear based on the project type methodology if I’m working with an external research agency or vendor. Sometimes it might be an internal research, I can just include a question asking the insights manager exactly that. And then based on the answer, let me say that this is an external research, actually. I will see that either an additional field pops up or in this case, even an entire new, yeah, step or a phase of the project, the supplier collaboration where I can ask for the proposal. I can commission them and, yeah, just really follow along the workflow by answering the simple questions. This is guiding me through the process, of course, in a compliant way, documenting every little piece of information that we need to have saved and readily available at one, click essentially whenever needed. Yes. And this is what I wanted to show you here about our adaptable workflows. I will hand it back over to Tania, but of course I will be back in a few moments when we talk about the next topic. Thanks, Sabrina. So the next key feature that we wanna highlight are approvals and alignments. Now approvals are really helpful because, it allows to define mandatory steps of the market research flow. So really defining who needs to approve what content when in the project to allow for a timely and smooth project continuation. So it really helps to remove any frictions. And, we also offer alignments that is basically an optional way of gathering inputs from other business stakeholders. So let’s say, you know, in the brief, there are some parts that really need some alignment with somebody else from the business that’s not particularly part of that research, project, but that person can be invited to comment or to review, and that is optional. So this is again a very nice way to ensure that all the activities that are pertaining that projects are being done in the tool and they’re being tracked, and they’re being made visible for transparency. We also have the automatic reminders, here, as well as being able to to forward any requests in case any of your stakeholders or approvers are absent. But let’s actually take a look how this works in the platform. Over to you, Sabrina. Yeah. Thank you, Tanja. Exactly. And I’m gonna go ahead and share my screen again Joe we can have a look at the same project that we looked at earlier. And something that you have seen maybe in the very beginning of the presentation when when Tanja was introducing MarketLogic is that we do have quite a bit of experience when it comes to pharma and health care organizations and, of course, their respective business realities. So when it comes to those approval flows, we are really able to, yeah, to customize them and also to reflect quite complex realities. If for example, you think about multi country studies or maybe multiple phases that a project is rolled out and all of this can be easily reflected within the approval flow. And one thing that Tanja has mentioned is that based on, a few, yeah, project parameters that might include something like the region or the methodology. You can have a specific approval flow, but and that is important also based on input. So if someone answers again the the the the the question based guidance. If someone answers a certain field with a certain input, then the approval flow will change accordingly. And it’s not only the approval flow. I’m pulling it up here. We call this our approval pane on the left hand side. This is just an overview of all the approvals that are needed for the entire project. And what what I was going to say is the, the approval flow that you see is not the only thing that depends on the the answers given by insights managers, but also who the approvers are. So if someone is in a certain country, there’s very likely a certain person with authority to grant approvals and all of this is reflected within the approval flow. In our example project, I have already requested some approvals and I have received the approval here. We’re good to progress essentially. The one thing that I wanted to point out, of course, depending on the approval step itself, the section that you want someone to review and approve best case scenario, of course, will be locked from the moment of requesting, but it will remain locked. We can, of course, not allow for any changes to be made after the approval has been given. And that’s just something that I wanted to point out here. So where previously we were able to edit to change information once the approval process kicks in for compliance reasons that is no longer possible. And maybe just one more note before I actually show you how to request an approval. It is, of course, possible for everyone who’s part of a project. And they can be a team member, but they can also be an approver for them to communicate. As Tanja has said, we wanna make sure that every and all communication stays within the same container. Nothing’s lost in email chains. So I just wanted to point out here I’ve given some input, the background of the project. And as you can see, Tanja has made a comment earlier. Now based on this comment, I have then decided to put the input, to change the input of the field and this can always be tracked with our history icon. So this is for full transparency, full visibility, documenting really every step. So this was the initial input. I saw Tanja’s comment. I know she’s an approver for my project and I’m adapting my input based on her feedback essentially. So once this is done and I’m ready to, yeah, move on within my approval flow, I’m gonna move maybe to the ethics and compliance approval. When I click on request and we set this earlier, it depends really on the project setup and the the the input that I have provided as the insights manager. What selection I see here? Who has to approve? Are those approvals dependent on each other? Is there a sequence? Is first, maybe the approver going to to give their approval and then the the MR project initiator and then the research lead, or can everyone answer at the same time? All of this can be set up so that the insights manager does not need to think about it at all. In fact, if there’s only one person with the authority to approve, they will be preselected. And even if there are multiple people, they will only see the list of those who can grant approvals without having to, yeah, without having to to guess or go through entire teams. So this is, yeah, already giving them a preselection, making it as easy as possible for everyone to be able to, yeah, request the approvals from the right person at the right time. I have an email here. Of course, I’m able to edit this email. It’s not needed. You can, however, and then whenever you are ready, click on confirm. This now does two things, of course. It notifies the approvers either in sequential order if this is a dependent approval or everyone at once. And secondly, as we have said before, it locks the sections that they are supposed to review and approve. And I’ve selected Tanja here as an approver. As you can see, she has already granted her approval. Now the next person can can, review the project, grant the approval. And as Tanja said, if I would like to, I can remind them, of course, to make sure that everything here has been reviewed by the right people at the right time. I have time stamps. I have it documented properly. And, of course, this information can also be pulled if needed for any internal or external review. Yes. And this is the part about our, flexible approval flows. Tanja, I will hand it back over to you. Thanks, Sabrina. It’s, really great to see how this works, and I bet, this is taking off a lot of, you know, some mental work that needs to be done by insights managers who have to memorize, you know, whom to pull in at what stage of the project. So let’s move on actually to the next key feature we wanna highlight today. Another one that I know our pharma and health care clients love and that is, automized regulatory reporting. So we know there are very, high reporting requirements given the nature of pharma and health care, that you have to adhere to. So, we’ve made it possible to basically, customize these, regulatory reporting, yeah, so that we really sit together with you in the setup phase to say, okay. Whom are the, target audiences? What information do they need from the product from the project? And we can set up, you know, several of those reports containing those key information that’s needed from the project. And we also optimize them so that, you know, the insights team in the project cannot just pull them ad hoc, but actually, we schedule them and we define, to which location should they be sent to. All of this to really reduce the time spent gathering those inputs for those very complex pharmacovigilance reporting. And, over to you again, Sabrina, to see how this actually looks in the platform. Perfect. Thank you, Tanja. Once again, you’re sharing my screen. Please bear with us, everyone. And this time, I’m actually landing here, not in the project that I’ve shown you before, but in what we call the project inbox. So this is essentially where the insights managers can access all of the ongoing projects. This is also great, of course, for monitoring, for tracking purposes, have a look at what’s going on, what’s already completed even for for maybe the, the managers. And within this project inbox, you can find all of the the reports that are available. I wanted to briefly walk you through them so that you understand that, of course, we have different options available including the regulatory reports that can be absolutely customized to your needs or to the to the specific team’s needs that need to review them, that need to maybe document them and, make sure that they’re always available the speed of light whenever needed. So in the very top right corner here, there’s a three dot menu. And when I click on it, you will find the different export or report options that I have available. The very first option, the simple export, essentially would give me a downloaded Excel version of, the the information here of the the project or the research inbox. So I have the metadata that I can see in one Excel file. This is great if you just want to go to a status update meeting and you are really only talking very high level about what has been done, what has been completed, what’s still in progress, for example. The next export here, the extended export, this will download every single field of a project. This is not something that that is customizable, but of course it’s great if you maybe want to slice and dice the data a little bit on your own, you want to analyze it So you always have the option of having the entire enchilada if you will. And then we come to what Tania was also mentioning. The customizable regulatory reports. We have two different options here set up, the safety export, the PV audit export. And as you can almost guess from the names, these are, of course, for specific teams. So the target audience in here is very clear, and we have previously defined what information do they need. I just wanna show you an example here. I’m gonna I’m gonna pull the safety export. Let me go ahead and open that. And what you will find in here is essentially, yeah, exactly the information that I have previously decided on, probably with the team that needs to review this information, that needs to keep it safe. This includes really everything, including the the approval steps. So which approval has been requested and given by whom? This is really something that, the safety team needs in our case, in our example. And as Tanja has said, instead of me as the insights manager going in and downloading it, attaching it to an email, sending it to someone, those customizable reports actually can be set up on a recurring basis to either be automatically added to an external location. Think about maybe the team’s SharePoint folder or a Microsoft Azure folder, or they can be set up with an automatic email that then every month, every quarter, whatever is needed is sent to the right team to the right email distribution list, and everyone has the, yeah, the correct information in the correct place. If, any of this information is ever needed, the respective teams will be able to produce it with one click, the speed of light, and have everything readily available essentially. Exactly. And when it comes to reports, and this is just something that I have briefly wanted to mention here, There is another option that that we can make available from the the MarketLogic site and we call this essentially the audit trail. Now the audit trail export is essentially a chronological record of all of the activities and actions and changes that were made by the by the different team members within one project container. And it serves as, yeah, let’s say, a detailed history of events and and make sure that the information here is really kept captured, with time stamps, with who was performing the action, when was it taken, and and those, yeah, full downloads with every single, action tracked can also be provided if needed. That is not a problem. It’s it’s not something that usually comes up every every month as our regulatory reports that we can customize, but definitely something that we make sure you, the insights managers, can access whenever that is needed. Thanks, Sabrina, for walking us through. And, now we’re already at the last part of our key features that we wanna highlight today. And, now that you’ve developed your fresh new insights, you wanna make sure that, they reach your, business decision makers to help inform the decision making. So here we wanna now introduce two features, and that is storytelling with our knowledge zones to help telling powerful stories to engage with the business. And, they basically make it very easy to frame and package your stories in a visual, appealing, magazine like way using easy to use templates where you can, pull in different types of media to really bring your story to life. And then second, we also wanna introduce you to the first AI assistant for insights, DeepSights. This makes it makes it very easy to, yeah, access insights upon self-service, to extract insights from your vast knowledge base, and let you create insights reports on demand. So really summarizing and synthesizing key insights from your existing knowledge using generative AI. But, without further ado, let’s jump into the demo to see how this actually looks like in the system. Yes. Thanks again, Tanja. And for the last time today, let me go ahead and share my screen here. I would like to start with what we call the knowledge zones as Tanja has just mentioned. You can think of them almost like a mini website or an online magazine. It is really quite easy to pull them together. It’s a lot of drag and drop, but it creates visually appealing, engaging content, which most importantly can really make a difference when it comes to decision making within your organization. Because as Tanja has mentioned, what what we can do here is we have a unique opportunity to maybe take the newly generated insights from the project that that we’ve just managed in the in the previous demos. Once this is published, we can essentially take information from within that project, even from other projects or external syndicated sources from from any different content that you think might be relevant. And we put them together in one concise knowledge zone creating a, yeah, a single source of truth and being able to to contextualize the information to maybe provide a little bit of a framework to go with it. You can utilize knowledge zones to make recommendations and to impact decision making just to make sure that everyone in the organization understands the topic and and and the new data points in the right way, looks in the same direction, and interprets everything accordingly Joe that there’s a shared understanding of the the different themes and topics that are important to the business. Now this is a knowledge Joe. And if I just show you an example page over here, maybe the key insights, You can see immediately that we have different types of media that are that are combined here. We have a little bit of text. I have actually a dynamic news feed in here. So this is something that updates automatically. It puts in information from different, in our case, here RSS feeds. This is just to, yeah, to complement what what you are maybe putting out here into the business. The the story that you are telling can always be complemented by the latest and greatest information that is available out there on the Internet essentially. And as I was saying earlier, to put something together that looks like this really takes you minutes. We have templates. You can decide if you like images or if you want to include videos. If you want the full projects to be featured within the knowledge zones, you can include agile dashboards as well. Once again, just to ensure that your audience, the the viewers of this knowledge zone do have access to the the the most recent information without you or anyone else having to manually update this. Here, I have one agile dashboard. If I click on it, what you will see is once the data loads, this always takes a moment. But once this is loaded, it gives you information in real time. It allows your stakeholders to interact with the information. They can slice and dice the data. And you make sure that everyone, yeah, really stays on top of the topic absolutely informed with the most recent info, without having to to go in and manually upload anything. You can allow people to ask questions here. You can respond to questions. So knowledge zones are really a fantastic way to use, as we said, a little bit of storytelling to make sure that that US stakeholders, the people who who need to care about the information that you’ve maybe just generated with a new piece of research, that they understand it correctly and make the best decision possible for the business based on what they’re seeing in your knowledge zone over here. And now last but very much not least, we’re switching platforms because I wanna show you a new feature innovation. Completely hot off the press, very exciting, and that is part of our DeepSights product. Now most of you are probably familiar with DeepSights, the first AI assistant that is specifically trained to understand insights. And this is really what Tanja was talking about earlier. This is all about your organization being able to self serve insights on demand with GenAI and and finding, yeah, clear summaries of trusted sources. I’m just gonna go ahead and ask DeepSights a question, generate some answers, and then in the next step, I can show you our new product innovation. So here we now have, as I said earlier, the clear summaries that cite our trusted sources essentially. And if I go ahead, I can now also create full reports. Now those, yeah, insights reports can actually be even downloaded. You can share them with colleagues. You can include them maybe in presentations that you’re currently working on. And I just wanted to show you what this looks like. So let me go ahead and actually open such a, an an insights report for you. And again, what we’re looking at here, of course, is, our our key insights under the summary. So the the the little, insight pieces, you will always find that we have linked sources directly behind each individual statement. So you can verify and and cite exactly where the statement is coming from. And then you also have the the option to just navigate to the sources tab directly here to understand, yeah, which reports, which content pieces were part of generating this insights report in the first place. Just to understand the overview here, what was, yeah, taken into consideration to produce your new insights report. I’m actually gonna stay in the first step here, the summary, because what I did wanna point out is how you can export this report now for yourself. You can download it either in a PowerPoint format if you like. You can also go ahead and download it in a Word document. Whatever you choose, it will include, of course, the summary, the sources, the file details. Let me just go ahead here and click so we can generate our report exactly, and I’m gonna go ahead and open it up. So this is now the file that, yeah, you can send to a colleague. You can use to maybe produce, a new report, a presentation. You have everything here available, can save it, can make sure that everyone who needs access to this has it. And, of course, it’s a great way for your entire organization to be able to to find the exact information they need fast and, yeah, have DeepSights help them create essentially new insights and find what is available on the system, including all of the research projects that maybe were published on your platform. And with this exciting teaser about the the new insights reports here from our DeepSights product, I’m gonna hand it back over once again to Tania. Let me maybe say, thank you from my side already, but, of course, Tania has a few more key takeaways for us, and we have time for your questions. Yeah. Thanks, Sabrina, so much for helping me running, the demos here. So I quickly wanna wrap up with some of the key takeaways. So let me start with the first one here. MarketLogic’s research management toolkit really offers a unified solution to support, your research process end to end. Yeah. It eliminates the risk of accidental, uncompliant behavior by setting up workflows that match the compliance requirements, that reduce complexity as much as possible while at the same time adhering to, your compliance requirements. And they really help to take the insights managers almost by the hand and, you know, guide them through the projects, making it as easy and less less frustrating as possible, really mastering their research. Create one single source of truth. So bring everyone who works on the project into one space. All the information and documents available are basically easily accessible to everyone who should access who should have access to them, you know, supported by, automatic reminders and notification emails. Again, all of those nice little supporting tools that make it as easy as possible for the managers to navigate those naturally complex product projects. Make compliance reporting easy. Reduce the time spent, gathering inputs for your pharmacovigilance reporting, by making use of those customized reports, being able to schedule them, and really being able to, yeah, set them up in a way that they are addressing the needs of your different target audiences, be it internal auditors or external auditors, and having the ability to create an audit trail. Yeah. So every activity in the project is basically being logged, and we give you the possibility to have access to that. And then last but not least, for insights sharing, storytelling is a very impactful tool as it allows you as experts to frame key insights in engaging and memorable stories. And if you do wanna learn more about inside storytelling, I highly recommend you to watch our insights boot camp episode, around storytelling. You should be able to see the link here at the bottom of the screen, so go and check it out. Now, looking at the time, I think we do have one or two minutes to address some questions. So let me go ahead here and Rini our q and a chat box. What data can the AI read? So I guess this is, on, the deep side’s assistant that Sabrina has shown. And, so currently, our deep side assistant can read, primary research documents. It, it can also, interrogate RS news feeds and also secondary, sources. So if you have, you know, any syndicated sources, licensees, we can onboard or integrate this data so that the assistant is actually able to also read that information. Let me take another question here. Is the AI feature connected to the research feature? So, in the end, it’s basically all connected to one platform to really ensure this end to end connection, which means that if in the research management, you know, tool you’re producing and developing fresh insights, these are indeed, feeding the knowledge base which DeepSights is taking as a foundation to draw answers from. So the short answer is yes. It’s all connected. Good. So I think we’re running a little bit out of time. Before closing the sessions, I do wanna, again, just emphasize on our AI for insights innovation. So, our DeepSights assistant that is really answering business questions in seconds, using GenAI and also creating those insights reports on demand. So really making sure that all your, insights are interrogated and synthesized, and the summary is created based on that and packaged in a nice report that you can easily take into meetings or, you know, build into your, your corporate or strategy decks. If you wanna learn more about our DeepSights assistant, go ahead here and, just scan that barcode, to learn more about it and get in contact. This brings us to the to the end of our, yeah, boot camp session today. Thank you so much for joining Rini and myself. We hope you’ve taken something away from the session. If you, have further questions or you’re even ready to, get your personal demonstration, go ahead and reach out to us. You’ll find us here on the web page, or you can get in touch with us via our, email. We are very much looking forward to seeing you on our upcoming events. So please look out for invitations. Thanks so much again, and bye bye. Thanks, everyone.
We know compliance is not a compromise for Pharmaceuticals and Healthcare companies. Pharmacovigilance and government regulations make market research complex (due to elaborate workflows), lengthy (given the high demand for reviews, approvals, and reporting), and pose great financial risk when non-compliant.
Through this webinar, we would like to share the best practices for intelligent research management in the healthcare and pharmaceutical industries. Also, you can learn how to support flexible workflows, process and reporting automation, and end-to-end knowledge management in one place.
This webinar is for you if you wish to learn about the following:
- Adaptable workflows crafted to align with your business and regulatory needs.
- Ensuring 100% compliance with the support of a comprehensive approval engine.
- Mastering automated regulatory reporting to reduce the time spent gathering inputs for Pharmacovigilance audits.