Clinical trials are experiencing a major transformation. While the core goal remains bringing safe, effective treatments to patients, how we reach that goal is changing fast.
What’s driving this change? The emergence of Agentic AI – a fundamentally different approach that goes beyond traditional automation.
Unlike conventional AI tools that require constant human direction, Agentic AI systems can understand complex clinical contexts, make informed decisions, and execute multi-step workflows independently. This represents the next evolution in AI capability, designed specifically for the sophisticated decision-making that clinical research demands.
At OCT East 2025, Saama’s Chief Products & Innovation Officer, Prasanna Rao, shared what this next leap looks like:
“The trends we are seeing is that generative AI is emerging into something called Agentic AI, which is a lot of reasoning on top of what is out there as models.”
Watch the full clip below to hear Prasanna’s vision for the future of AI in clinical trials:
Let’s take a look at how AI in clinical development has evolved over the years, what makes Agentic AI different, and how it’s unlocking new levels of autonomy, role-based support, and speed across the trial lifecycle.
First Generation: The Machine Learning Foundation
The first wave of AI in clinical trials focused on traditional machine learning and early AI platforms. These systems brought pattern recognition and basic data analysis automation to clinical research. Organizations started experimenting with predictive analytics, basic data validation, and simple workflow automation. This generation of AI needed a lot of manual setup and oversight. The technology was mostly reactive: it would process data when you asked it to, but it couldn’t really understand complex clinical situations or adjust when trial conditions changed.
Second Generation: The Generative AI Revolution
The emergence of large language models (LLMs) and conversational AI platforms marked a significant leap forward. This generation brought natural language processing capabilities that made clinical data more accessible and enabled intuitive interactions between clinical professionals and AI systems.
Clinical professionals could ask questions about complex datasets in plain English, generate protocol documents, and automate routine emails. However, this generation remained largely conversational, requiring human direction for each interaction.
Third Generation: The Dawn of Agentic Intelligence
Now we’re seeing the emergence of Agentic AI, and this is a big shift from conversational systems to intelligent agents that can actually reason, plan, and execute on their own. Unlike what we had before, Agentic AI doesn’t just process information or respond to prompts.
Saama’s Agentic AI Framework exemplifies this evolution, deploying specialized AI agents that autonomously assess, execute, and report tasks throughout the clinical development lifecycle. These agents go beyond simple automation by reasoning through complex scenarios and making informed recommendations based on contextual understanding.
See how Saama’s Agentic AI transforms SDTM generation – watch the on-demand webinar now.
The Persona-Specific Revolution
As Prasanna Rao notes, data managers in clinical trials perform a wide range of tasks: validating data, identifying discrepancies, navigating multiple systems, and ensuring compliance. Traditional AI systems often treat these activities as disconnected, requiring different tools and significant manual effort.
Agentic AI takes a more integrated approach. It understands the full context of the role and connects related tasks into one continuous workflow. This persona-specific intelligence can augment the work of site coordinators managing patient visits, biostatisticians working on efficacy analysis, or regulatory specialists preparing submissions. Each can benefit from AI agents that are purpose-built for their daily responsibilities.
Saama’s Agentic AI Framework: AI Operating System for Clinical Development
To help clinical teams move from automation to true intelligence, Saama has developed an Agentic AI Framework that serves as an AI Operating System (AIOS) for clinical development. The framework allows seamless deployment of specialized AI agents tailored for specific clinical use cases, from patient narrative generation to inclusion/exclusion criteria drafting.
Key capabilities include autonomous decision-making where agents generate plans and reason through complex scenarios, AI-powered clinical operations supporting data review and trial monitoring, and modular agent deployment that enables easy integration of new specialized agents without disrupting existing workflows.
The Competitive Advantage of Early Adoption
As Prasanna highlights, “Now what we are going to do next is, as technologists, we are going to look at every single persona in clinical trials.” This vision captures exactly where the industry is headed. The Agentic AI era has begun, moving beyond simple conversations to specialized agents that understand and execute complex clinical workflows. Organizations that embrace this transformation today will be the ones leading clinical innovation tomorrow.
Ready to see how Agentic AI can work for your clinical team? Contact us at [email protected] to schedule a personalized demo.
