Hi, everyone. Good morning, good afternoon. My name is Matt Moyer, I'm a Director with Merck in the Clinical Supply Technology Group and I'm here with Naru who's with a Tata Consultancy Services ADD platform. And he and I are going to be talking to you today about enabling the next generation patient centric trials via an open digital platform. I'm going to provide an overview of a case study from Merck or. MSD. And will then give you details on the ADD platform itself. Next slide. So what do we mean by digitally enabled trials platform? It's really important to recognize that the number of devices that are needed nowadays in trials is growing exponentially. And each of those devices represents A disparate source of data that needs to be harmonized, aggregated and reconciled both between themselves as well as all of the places that data needs to go, whether it's into a data lake in order to run advanced. Politics, whether it's into our clinical study repository for reporting purposes, whether it's ensuring that site staff can have visibility via real time dashboard that highlights key pieces of information that they need to know. And in addition to that, we also need a mechanism to engage with the patients in our trials, whether it's via reminders, delivery of E pro or other survey style information. We need that capability as well, all told. We need a central hub to act as that in data integration layer with mobile app capability and we see that digitally enabled trust platform is providing that capability. It allows us to support both during the study activity as well as after study reporting. Next slide. So to bring you through a specific case study where we used the DETP approach from Tata Consultancy Services, they're connected clinical trials platform. We had an adherence device that was Bluetooth based. It was a homegrown device. It had the capability to perform active and passive data transfer we needed and it would time date stamp, the patient interaction with that device. When they removed the cap, it recorded a time date stamp and either stored that data locally or would transmit that data. To a resting place. We needed to be able to collect that data, make it visible, and we needed to do it in real time. We needed the ability to be able to send patients reminders of their upcoming doses and reminders if they missed the dose. We needed to be able to store that data in the interim, And we needed an API available for data download. We needed the data to be transferred passively. We didn't want this to be any more burdensome for the patient. Than using a normal device and so we wanted everything to happen in the background and we wanted the data to be available. We also wanted it to be BYOD or bring your own device. Meaning that it all the patients who wanted to participate in the trials simply had to download an app from the Apple or Google App Store that would allow them to then configure their device and participate in the trials. And so you can see on the left the flow of information data coming from the Bluetooth based center on our device. Active and active or passive data transfer into the platform and then an API for data download into our internal systems where the data needed to go. I wanted to speak just briefly to the roadblocks or challenges that we ran into, both while deploying this as a technology solution as well as just generally speaking. The culture of change is a very challenging one and ultimately affects the ability to drive adoption of these innovative solutions. And so as an example, we would hear comments from clinical teams saying that if the solution that you have. It doesn't work in all sites, all geographies, all regions, 100% of the time, then we don't want to use it. And while we recognize that a global adoption of a solution, you know, may be challenging for folks, we really recognize that there's a there's value in being an early adopter and even a targeted application of the challenges that we see here. We can solve these challenges even if it's not in one harmonized. Approach because of the regulatory adoption is not quite there or we've not got the kind of the technology in the environment or in the geography that we're in for the trial. So the willingness to be open and flexible to that is very important. I'll also say too that the collection of this data needs to be done under GXP's. So we need the trackability, traceability of data and the ability to recall that data at any time. And that it meets all expected regulatory standards. You know that while there are many things you can do in the consumer space with apps and data that are pretty neat, we recognize that we work in a regulated clinical environment. And the structure around data and the metadata and the ultimately the usability, that data, the traceability, the compliance and handling of that data, including any concerns that there might be around privacy, personally identifiable information, things of that nature. Are super critical and we need to make sure that we're thinking fully through those considerations in order to ultimately be able to drive the trial forward. These are just a few of the examples of the challenges that we face and had to overcome in order to move forward with the study as you see here and our continued digital application efforts here in MMSD. So with that, I'm going to turn it over to Nauru. We'll walk you through specifics of the ADD platform and what it offers. Thank you, Matt. And moving forward with the whole platform approach. So the TCS approach for a patient centric clinical trials platform is about looking at 2 layers of serving patient centric to our values. At the very top are the core requirements such as ability to various kinds of engagements in a plugin play model, whether it is to do consent, connect with the various smart technologies, the guide patients and sites in a step by step. Collect the data and track it. In this particular use case, we did the activity of collecting the data, connecting to the devices, guided patients in a step by step manner, tracked their medication compliance and adherence the next layer is all about leveraging the richness of the data, leveraging the richness of the ecosystem to prevent potential safety issues. Is there anybody could put a patient safety at risk. Embed these capabilities as a part of a. Slide to doing things in a way which is not very intrusive. Doing it in a way as a part of the normal day-to-day life. Looking at the augment capabilities in terms of enriching the experiences and using the rich data that we're coming from various sources to personalize how you want to engage with them. So these are serviced through the add connected clinical trials platform through the patient inside engagement supply management and the device and connections capability and. Bringing much more richer data through specific capabilities such as behavioral insights, personalization, communities and so on. So All in all in order to meet that particular objective of larger vision of MSD what TCS vision is for patient centric platform and that supports them in these data collection to the enriched data analytics capabilities. And the whole concept is good because we see a lot of experiments happening. In pockets, people do one of trials with specific instruments such as the smartwatch, such as mobile device such as a particular variable or any other smart medication package. But the challenge that you see on the left is that many of these are. Huge burden on the patients and the sites, especially when it comes to ability to deal with the change, the training, the support, the hardware management, the logistics etcetera, which restricts the usage of some of these technologies today to a few one of pilots and these are not really mainstream today. What the platform approach however does is it removes that barrier of eruption, helps us move from one of pilots to a more scalable mainstream adoption approach which means that in future every single trial would be able to use these technologies at optimum change to a patient. Not a huge change to the sites and not increasing their burden but making their life easier. And the core of this is an integrated and flexible platform and the core philosophy of this that we would like to support and it's open ecosystem where you can plug and play various technologies, various mobile apps, various hardware devices. Mass technologies and so on. And thereby bring rich datasets all integrated at one point and providing useful insights, actionable insights for the study teams, for the sponsors, for the Cras and for the physicians. So the core 3 value adds that we see from an approach like this is we can reduce the hardware burden, we can enable it on any device, we can simplify the user experience. And while doing so, we have also got quite a few learnings along the way. And these learnings are based on the direct feedback that we connect from stakeholders and also indirect feedback that we see in terms of what gets adopted. Needless to say, there are several barriers when it comes to the learning challenges, the adoption challenges, the continuity challenges and some of the ones that I want to talk through with some examples of how we try to remove those obstacles start from example from patient's point of view a direct feedback. If the patient doesn't see something valuable, they don't use their technology. And many of the technologies we have done in the past often have heard in the sense that they've been trying to push something to the patient without really understanding what is in it for them. And answering this question actually has helped us in adopting in better adoption of these technologies by the patients and the sites likewise. Bring your own device or ability to give the flexible options. If you want to do it on your own device, use it. If you don't want your personal device to carry your clinical trial data, give them the option of a provision device. I think this kind of flexibility for extremely important because there is no one rule that applies across the various demographics of patients that we see in clinical trials. Providing a paper process backup is extremely important. So it can't be like you would expect every technology to be fully failed to. There are networks matches, There are parts when a patient is doesn't have a charging unit, doesn't have a battery. There are a lot of practical reasons why the technology might not work perfectly, and one of the key learnings is to think through each and every failure point, Look at what is a good alternative process at the backup so that nothing is lost, so that at the end of the day it's a smooth experience for everybody. Likewise, on the site side, one of the core thing is the time is critical, so you can't use too much of that. Time in answering patient queries, too much of their time in duplicating effort in clinical trial systems and what they do in the healthcare world, you can't put a lot of slowness around how they deal with multiple systems and multiple hardware. And so these are some of the key things that you need to take care of from a site point of view and that's where the platform approach helps, how it helps us, you can bring it all in one user interface on one device. Everything connected seamlessly, so thereby avoiding the whole hardware integration. Of course it's easier said than done, but this is something that will help the adoption for the sites like this. From study teams point of view, there's a learning curve because quite often when these technologies are introduced, you need advocates. You need strong advocacies in the study team so that these tide opted well and in order to do so, we should remove the initial barriers to adoption, such as how do I take care of a lot of different countries. specific regulations, how do I take care of translations, languages, IRP packages, these are the things which are quite often the operational challenges that study teams face and therefore they resist adopting these technologies. So these are some of the key learnings we've had along the way and something that we are working collectively with our customers to solve and make it a much more easier experience of introduction of technologies. Finally, from a future point of view, we do think this is still a beginning. The future is out there. And as we see people adopt many different kinds of novel technologies in their day-to-day interactions and we see that this is just the start and this is just the beginning.