https://lnkd.in/eWNFEHfM AI already plays a big role in pharma. Now agentic AI, a type of system that marks a significant shift from traditional AI models, is poised to make an impact in clinical research. However, allowing AI to act independently requires careful planning and knowing when to allow the technology to run free and when to call in human support. #lifescience #biotech #medtech #medicaldevice #healthtech #AI
Agentic AI set to transform clinical research in pharma
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Organizations and teams recognize the criticality of establishing Key Performance Indicators (KPIs) to assess and appreciate the value they bring. The transformative power of Artificial Intelligence (AI) is substantial, underscoring the necessity of commencing the AI venture with clearly outlined use cases tied to quantifiable KPIs.
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Even before 2025, AstraZeneca had been an early mover in applying AI. Now they are using Agentic AI to compress discovery cycles and lower failure rates. The results are staggering: https://lnkd.in/eW8JMFCR
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GxP (Good Practices) is non-negotiable in clinical AI. We've written more about. Have a read: The Compliance-Built Future of AI in Clinical Trials https://lnkd.in/g8xG9TEN
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The clinical-research industry is moving from caution to clarity in its use of artificial intelligence. Artificial intelligence is currently rewriting the operating model of modern clinical research. Across sponsors, CROs, and regulatory bodies, the technology comes with promises to compress timelines, enhance data quality, and unlock new layers of transparency. Yet, with every breakthrough comes a parallel concern: how to ensure that automation serves science without compromising compliance, patient safety, or public trust. The life-sciences sector operates under the strictest governance frameworks in the world. Every process, from data capture to documentation, must be defensible, auditable, and aligned with Good Practices (GxP), the global foundation of regulatory integrity. The FDA and EMA, among others, have made their position clear: the use of AI in regulated environments is not prohibited, but it is conditional. Systems must demonstrate credibility, maintain human oversight, and adhere to the same standards of validation, traceability, and quality expected of any GxP-compliant technology. That tension defines the industry’s current moment. Teams recognize the inefficiency of manual documentation but remain cautious about technology and tools that “automate”. The challenge, as such, is not the technology itself. It is designing AI that respects the rules, strengthens compliance, and withstands regulatory scrutiny. In the following article, we explore how these principles are being formalized across global frameworks and how Clinials, built from day one on GxP and responsible AI standards, demonstrates that compliance and innovation can actually advance together. https://lnkd.in/g8xG9TEN
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Check out this post from Michael Gibney which elaborates on how artificial intelligence is poised to transform drug discovery and development. Within the next five years, which area(s) of R&D do you think will be most impacted by the application of AI? https://lnkd.in/enRiKDZp
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In the first installment of our practice’s series on AI governance, we describe how the potential of AI to transform activities like drug discovery and clinical trials makes comprehensive AI governance frameworks essential for life sciences companies. Learn how to balance innovation with compliance through three key stages: concept review, design and deployment, and continuous monitoring. Great teamwork and thoughtwork by Gary F. Giampetruzzi, Amir Ghavi, Ann Beasley, Sarah Volden, Jessica M., Ravneet Talwar, and Julie Kudyba - looking forward to the next installment in the series!