Hello everyone. My name is Lata Putar Laka, and I'm currently working as a senior, a and developer at the US Food and Drug Administration. I bring 18 years of experience in the financial and healthcare industries. Having worked extensively as a QA automation architect, I have a strong background in automation. Quality assurance and process optimization. Today I focus on leveraging low-code platforms to accelerate application development, streamline workflows, and deliver scalable solutions that meet complex business needs. My deep industry knowledge, combined with low-code expertise, allows me to build efficient, compliant and user-friendly applications that drive innovation and operational experience. I am passionate about creating scalable applications using visual development tools, enabling me to rapidly deliver powerful solutions that bridge the gap between business needs and technology. By minimizing traditional coding, I help accelerate project delivery, improve collaboration, and drive digital transformation. I enjoy turning complex problems into simple automated workflows that empower teams and enhance productivity. I am excited to take you through a journey of transformation from the fragmented manual process. That have long slowed down clinical research to a future where automation and low-code platform drive agility, precision, and innovation. We are going to explore how modern clinical research operations can evolve through smart platform engineering, leveraging low-code technologies and automation to remove inefficiencies, reduce human error, and ultimately accelerate the delivery of medical breakthrough. Our goal is not only improve research outcomes, but to positively impact patient care, faster, smarter, and with greater reliability. Let's dive in. To understand why automation and low-code platforms are so critical, we first need to acknowledge the challenges that currently plague clinical research. Despite being the engine of medical innovation, clinical research operations are still bogged down by three major issues. First, there's paperwork overload. Many teams still rely on paper forms, manual data entry, and physical documentation. This creates bottlenecks, increase the risk of human error, and add significant time and cost to every phase of research. Second, regulatory complexity. Navigating complaints, requirements across ethics boards, government agencies, and institutional review boards is not only time consuming, but resource intensive. It creates a massive administration burden that distracts from actual research. And finally, fragmented data systems. Researchers are constantly switching between siloed systems, EHRs, lab systems, trial management platforms just to reconcile data. Instead of analyzing results, they are stuck performing tedious data integration task at the, and the image here tells a story. Brilliant minds are stuck under piles of administrative work when they should be innovating. This is the reality we aim to transform. Even though research teams are highly skilled and deeply committed to advancing science, the reality is they are spending far too much time on administrative work instead of research. Let me share some numbers that illustrate the challenges. 60% of research coordinators time is consumed by documentation and manual data entry. That time they could be spending engaging with patients or focusing on trial execution, but instead they are managing forms, spreadsheets, and disconnected systems. On average, a researcher has to log into three to five different systems each day just to complete core task that adds unnecessary complexity, drains time, and increases the chance of data inconsistencies, and the impact is significant. 25% of clinical trials are delayed not because of scientific barriers, but due to the administrative bottlenecks. That's one. In our four trials, potentially life-saving treatments slowed down by outdated workflows. These inefficiencies are more than frustrating. They directly delay patient's access to new therapies. Clearly, it's time to reimagine the way research workflows are designed and executed, and that's where automation and low-code platforms come in. Now that we have seen the challenges, let's talk about our vision. We believe clinical research platforms should no longer be a source of frustration, but instead a source of empowerment. Our goal is to build platforms that are modular, automated, and integrated modular so that they can evolve with research needs, adapting without requiring full results. Automated to remove repetitive to manual task, freeing up researchers to focus on the science. And integrated so that data flow seamlessly across systems, reducing friction and improving accuracy. Ultimately, we want researchers to spend less time wrestling with tools and more time doing what they do best, innovating, experimenting, and pushing the boundaries of science. Technology should handle complexity behind the scenes. That's the heart of our approach, using smart automation and low-code platforms to make the heart vision a reality. We are not just solving human efficiencies, we are accelerating medical progress. Now let's talk about how we can bring this vision to life, and that's through low-code platforms. Low code is a game changer because it allows research organizations to rapidly build and evolve applications without requiring deep software development skills. There are three powerful benefits. One rapid prototyping. Research teams can test and deploy new workflows in days, not months. This speed means we can spend faster than. New to new trial needs, regulatory changes or process improvements without wasting for traditional IT talent. Second is the customizability. No two clinical trails are exactly alike. Low-code platforms allow for flexible configurations, so each workflow can be tailored to the unique needs of the study without rebuilding everything from scratch. Third and last, accessibility, perhaps most importantly, low-code makes digital transformation more inclusive. Even non-technical stakeholders like clinical coordinators, regulatory leads, can take part in designing workflows that meet their day-to-day. Operational needs. So in essence, local enables smarter, faster, and more collaborative innovation, and it's one of the most effective ways to remove friction from research operations. This case study really brings a transformation to life. Let's start with the challenges before implementation, which are all too familiar across many research teams. The first one is a manual data entry meant that staff were entering patient information into spreadsheets, a slow error from process that created data about clinics. Startup delays occurred because trial immunization depended on fragmented systems and manual approvals offered dragging timelines out of weeks. And complaints are nightmares where audits require weeks of staff time to manually gather, validate, and compile documentation for regulators. Now look at the impact after implementing low-code automation, electronic data capture replaced manual forms with automated systems, improving data accuracy and reducing delays. Streamlined startup. Automated workflows meant trial minimization. Time dropped from weeks to just pace, and finally, the continuous complaints. With real-time monitoring and built-in audit trials, staff could meet regulatory requirements without the chaos and last minute scrambles. This shift didn't just improve efficiency. It fundamentally changed how the team worked, enabling them to move faster with few errors and more confidence in compliance. Now let's take a look at how this solution comes together. From a technical perspective, we have built a modular platform architecture where each component is designed to work independently at, seamlessly integrates with the rest of the system. First, we have data capture. This is where clinical data enters the system either through electronic forms, APIs, or direct system input. It ensures accuracy right from the start. The integration engine connects diverse tools like EHRs, lab systems, and third party software into a unified workflow. This eliminates the friction of siloed systems. With workflow automation, we streamline routine tasks like documenting, routing, notifications and approval ing, reducing human intervention, and speeding up timelines. Complaints man. Monitoring is a built in, so audits and checks can be done in real time, and we maintain a clear audit trial without needing extra effort from the team. Finally, the analytics dashboard gives stakeholders clear visibility into performance, bottlenecks and trends, allowing for faster data-driven decisions. The key takeaway here is flexibility. Each component is independently deployable, meaning we can scale or adapt to changing regulatory and clinical needs without overhauling the entire system. This slide highlights one of the most powerful shifts enabled by our platform, moving from periodic to continuous compliance. Traditionally, complaints relies on scheduled audits, which are reactive and time consuming. But with automation, we take a proactive approach. Real time validation rules captures inconsistencies as data is entered, preventing errors before they can snowball. Automated crosschecks can run behind the scenes continuously, comparing data across systems to flag discrepancies early. Comprehensive audit tile trials are automatically generated, sharing every system interaction, and making it easy to trace what happened, when and by whom. And we have automated complaints reporting, which can instantly produce regulatory documents. No more scrambling for audits. The result, we have seen error rates reduced by 87%, and compliance preference time cut by 65%. That means fewer surprises, less manual burden, and significantly faster audit readiness, all without sacrificing a rigor. Technology alone is rarely enough to de drive successful transformation, especially in risk adverse clinical environments where change can be met with hesitation or resistance. This line or this slide outlines key human factors that ensures smooth platform adoption. Stakeholder buy-in early engagement with researchers, coordinators, and regulatory staff is critical. This involvement helps. Align platform features with real on the ground needs rather than relying on assumptions. When people heard and involved, they more invested in success. Change management. Rolling out new technology can disrupt workflows. So structured training programs and phase rollouts are essential. These approaches minimum disruption and build user confidence step-by-step, promoting progressive success, user-centric design. Our interfaces are designed for usability across Tyler's technical skill levels, so that users feel encouraged to adapt the platform rather than resist it. Intuitive two, design reduces friction and fosters positive user experience. Pilot programs starting its small control trials, allows us to demonstrate tangible value earlier. This builds trust and creates internal champions who advocate for wider implementation later. Addressing these human factors alongside the technology itself is vital for truly successful transformation in healthcare and clinical environments, resistance to changes common due to concerns around complaints and operational risks. Our approach specifically targets these barriers with four key strategies. Regulatory alignment. We demonstrate however automation tools enhance compliance rather than compromising it. This helps elevate fears that new technology will create regulatory issues, it improvements rather than overwhelming users. With big challenge at our at once we roll out improvements gradually. This phased approach helps staff adapt more comfortably and reduces resistance. Outcome Deco documentation. We rigorously track and can document the positive results of platform adoption. This builds confidence among stakeholders by showing tangible benefits. Executive sponsorship. The last one. Securing strong leadership support is crucial. Executive sponsors help overcome organizational in error and drive monument for change from the top. By addressing compliance concerns, providing clear evidence of benefits, and managing change clear carefully. We help healthcare organizations move past the resistance and successfully adapt new platforms. This slide highlights the measurable business outcomes that demonstrate the return on investment from platform transition. In clinical research environments, reduced admin time by 42%. Automating administrative task reduces overhead freeing research staff to focus more on science and patient care rather than by paperwork faster. Trial setup by 65% By streamlining workflows through automation, we shorten the time from protocol approval for the first patient, enrollment accelerating trial. Fewer data queries, 87%. Automated validation at the point of data entry significantly cuts down on data clarification, request, improving data quality and reducing delays. Audit readiness automation provides compliance documentation on demand, greatly reducing the need for manual compliance during automation, during audits. Together these outcomes drive faster trial timelines, lower operational cost, and ultimately enable quicker delivery of treatments to patients. This slide highlights the measurable business outcomes that demonstrate the return on investment from platform transmission into clinical research environments. A reduced admin time by 42%. Automating administrative task, reduce overhead, freeing research staff to focus more on science and patient care rather than paperwork. Faster trial setup by streamline workflows through automation. We shorten the time from protocol approval to the first patient, enrollment and accelerating trial initiation, fewer data queries. Automated validation at the point of data entry significantly cuts down on data clarification, request, improving data quality and reducing delays. Audit Readiness automation provides complaints to documentation on de demand greatly reducing the need for manual comply during audits. Together these outcomes drive faster timelines, lower operational calls, and ultimately enable quicker delivery of treatment to patients. This slide highlights three transformative trends shaping the future of clinical research platforms. AI driven analytics machine learning algorithms will enable early detection of patterns in trial data. This leads to smarter decision making and the potential to product patient outcomes more accurately improving trial success. Blockchain for compliance immutable ledgers provided by blockchain technology will enhance transparency and trust among all stakeholders. This will simplify compliance management, especially for multi-site and international trials, ensuring data integrity and audit readiness. Global interability. As research expands across borders, platforms must integrate seamlessly with diverse healthcare systems and navigate varying regulatory frameworks. This will facilitate smoother collaboration and data sharing worldwide accelerating medical advancements. These innovations promise to make clinical research faster, more relatable, and more collaborative on a global scale. This slide emphasizes the shift in clinical research platforms from being tools solely for researchers to platforms that actually engage patients. The next generation on platforms will facilitate direct patient reporting via mobile and variable devices, enabling real time data capture beyond traditional settings. They will support real wide evidence collection, gathering data from everyday environments to better reflect actual patient experience. Patients will benefit from patient directed trail matching, where the personal health data helps identify relevant clinical trials. Additionally. Transparency DA dashboards will provide patients with ongoing insights into trial progress and impacts fostering trust and engagement overall. This evolution democratizes research participation leading to richer, more diverse data sets than better represent real wide conditions and ultimately improve study overcomes. This slide highlights the significant benefits clinical research platforms can achieve by moving from manual process to automation. Faster trials, automation accelerates discovery and process, speeding up the development of new treatments and getting them to patients sooner. Better data, automated platforms generate higher quality, more consistent evidence, enabling more reliable and actionable conclusions. Improve lives. Ultimately, these advancements lead to medical innovations that improve patient outcomes and contribute to a healthier world. In summary, embracing automation not only streamlines operation, but also enhances data integrity and drives meaningful improvements in healthcare. As we explore today, the future of clinical research platform lies in leveraging, cutting edge tech, cutting edge technologies and patient-centric approaches to transform how trials are conducted and how data is utilized. AI-driven analytics enable us to detect patterns earlier and predict patients outcomes more accurately, making decision making smarter and faster. Chain technology ensures transparency and trust, simplifying complaints across global multi-site trials. With global interoperability, we can integrate diverse healthcare system and regulatory frameworks, making cross border research more seamless and efficient. Equally important is the shift towards patient-centered platforms. Empowering patients through direct reporting, real world evidence collection personalized trail matching and transparency dashboards. This demo democratization of research participation will generate richer and more diverse demands reflecting real world con conditions better than ever. The journey from manual kiosk to automated excellence promises, remarkable rewards, accelerated trials, high quality data, and most importantly, improved live lives through medical innovation. Together these advances will drive a new era in clinical research, one that is faster, more reliable, and more inclusive, ultimately bringing us closer to better health outcomes for all. Thank you for your attention. I'm happy to take any questions.