How Agentic AI in Clinical Trials Is Transforming the Experience for the Better 

Key Takeaways:  

 

  • Agentic AI in clinical trials enables autonomous, goal-oriented problem-solving for recruitment, site selection, and real-time monitoring.  
  • Operational benefits include faster patient matching, reduced protocol deviations, and improved data oversight with human validation.  
  • Financial potential lies in cutting costs, accelerating timelines, and improving ROI, though savings remain largely theoretical at this stage.  
  • Frank, Rimerman’s role is providing financial analysis and strategic planning to help life sciences firms assess AI investments objectively.  

Clinical trials are the lifeblood of life sciences innovation, yet they remain one of the most expensive and time-consuming undertakings in the healthcare industry. Now, a new wave of technology called agentic AI is beginning to offer a smarter, faster, and more cost-effective way forward, though adoption remains in early stages across the industry.  

Unlike traditional artificial intelligence, which often follows fixed instructions, agentic AI consists of autonomous, goal-oriented agents that can independently make decisions and adapt to new information. This level of dynamic problem-solving shows particular promise for the complex and data-heavy nature of clinical trials. For companies navigating a high-stakes regulatory environment, agentic AI has the potential to bring both agility and accuracy, which are critical factors in achieving successful outcomes.  

However, it’s important to note that agentic AI in healthcare is still emerging. Most implementations remain experimental, with companies conducting pilot programs and proof-of-concept studies rather than full-scale deployments. The technology requires significant human oversight, particularly in regulated environments where patient safety and regulatory compliance are paramount.  

 

Smarter Clinical Trials Start With Automation

 

Operational efficiency is a major driver for adopting AI in clinical trials. Agentic systems show promise in automating patient recruitment by scanning and matching candidates to inclusion criteria at scale, significantly reducing the time it takes to fill studies. Beyond recruitment, these AI tools for clinical trials manage protocol adaptations in real time, minimizing costly deviations and delays.  

Another key benefit lies in intelligent site selection. AI agents are being tested to use predictive analytics to identify optimal trial locations and coordinate logistics more effectively. The result? Reduced resource waste and smoother trial execution.  

 

Real-Time Data, Real-World Impact

 

Monitoring data continuously during trials is essential but traditionally difficult. Agentic AI shows potential for operations automation, providing real-time insights, flagging anomalies early, and enabling faster decision-making. This could help protect patient safety and improve regulatory readiness, with some systems being explored to assist in drafting compliance documentation.  

 However, these agentic AI use cases in healthcare require careful human oversight. Regulatory bodies remain cautious about autonomous AI decision-making in clinical settings, emphasizing the need for human validation of AI-generated insights and recommendations. The technology is evolving, but implementation must balance innovation with proven safety protocols.  

 

The Financial Opportunity: Projected Benefits and Current Reality

 

Perhaps the most compelling potential advantage of AI in clinical trials lies in financial impact. Automation could cut costs across the board — from labor to logistics — while accelerating timelines. Early financial modeling suggests therapies could reach the market sooner, generating returns faster for companies that successfully implement these technologies.  

Additionally, AI-assisted forecasting models are beginning to offer life sciences firms clearer insight into potential outcomes and spending. This improved financial predictability could allow for more confident budgeting and stronger margins, with lower trial failure rates potentially enhancing ROI.  

The key word is “potential.” While pilot programs show promise, widespread cost savings remain largely theoretical. Companies considering agentic AI investments need sophisticated financial analysis to separate realistic projections from overly optimistic vendor promises.  

 

Strategic Financial Planning in an Era of Emerging Technology

 

At Frank, Rimerman, we support our clients by providing the financial expertise needed to evaluate emerging technologies like agentic AI. Through comprehensive financial analysis, ROI modeling, and strategic planning services, we help life sciences companies make informed investment decisions about new technologies, whether that’s AI, automation, or other innovations.  

Our role isn’t to advise on the technical implementation of agentic AI, but rather to ensure our clients have the financial frameworks and strategic insights needed to evaluate these opportunities objectively. We help assess the true costs, realistic timelines, and potential returns of technology investments in the context of each company’s broader financial strategy.  

Agentic AI represents an interesting frontier for clinical trials, but it’s still early days. As this technology matures, financially savvy organizations will need trusted advisors to help them navigate investment decisions wisely. Frank, Rimerman provides the accounting, auditing, and strategic financial expertise to help you evaluate these emerging opportunities through a clear financial lens.  

 

Ready to evaluate emerging technology investments for your clinical trial operations? Connect with Frank, Rimerman for expert financial analysis and strategic guidance on technology investment decisions.  

 

Disclaimer: The material appearing in this communication is for informational purposes only and should not be construed as legal, accounting, tax, or investment advice or opinion provided by Frank, Rimerman + Co. LLP or its subsidiaries or affiliates. This information is not intended to create, and receipt does not constitute, a legal relationship, including, but not limited to, an accountant-client relationship. Although these materials have been prepared by professionals, the user should not substitute these materials for professional services and should seek advice from an independent advisor before acting on any information presented. Frank, Rimerman + Co. LLP and its subsidiaries or affiliates assume no obligation to provide notification of changes in tax laws or other factors that could affect the information provided.

Frank, Rimerman + Co. LLP
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