SCOPE Summit 2025: Shakthi Kumar Talks Real-World Data Use in Clinical Development

ACT: Could you share real-world use cases where this technology has significantly accelerated clinical development, improved data integrity, or optimized regulatory compliance?

Kumar: I think that right now, Agentic AI is a marketing buzz. Last year, there were a lot of new developments, and I do believe that we have the reliable tools and platforms right now to build Agentic AI solutions for the industry. I can call out a couple of use cases that we are very excited to be working with our client sponsors on.

The first one is related to protocol adherence and compliance. For instance, any protocol deviations in terms of missed patient visits, or if it's outside the window, causes a cascading set of delays. We believe that by building a specific agent, the protocol we call it the protocol adherence agent, we are able to address this in real time basis and resolve this before it becomes a huge issue.

The other example is that we’re using it in monitoring overall efficacy of a particular drug and looking at any kind of safety concerns as well. So, we do believe that there is a number of other examples, but these are some of the things that we're working on.

Full Interview Summary: Edetek R&D cloud ecosystem addresses key challenges in clinical data management and analytics by creating a seamless digital data pipeline capable of collecting and transforming data from any source, format, or type. The platform integrates third-party software with event orchestration, ensuring security, collaboration, and scalability.

Agentic AI enhances these solutions by eliminating workflow bottlenecks and improving efficiency beyond traditional AI. While human oversight remains essential, agentic AI automates repetitive tasks and optimizes decision-making in real time. At the SCOPE Summit, Edetek highlighted its use of agentic AI in critical areas such as protocol adherence, where AI agents detect and resolve deviations in real time to prevent cascading delays. Another key application is monitoring drug efficacy and safety, ensuring regulatory compliance while accelerating clinical development.

Interoperability remains a major hurdle in clinical research, and Edetek’s cloud ecosystem addresses this challenge on three levels. First, its semantic integration approach eliminates costly implementations by offering pre-built connectors to over 100 data sources. Second, event-driven system orchestration facilitates seamless collaboration between different platforms. Finally, its capability orchestration model allows stakeholders to customize their cloud environment, enabling a flexible, scalable R&D infrastructure. These innovations position Edetek’s ecosystem as a transformative force in clinical data management, ensuring data integrity, compliance, and operational efficiency.