Knowledge Center

The numbers are in, and they spell change for life sciences. 

That’s because nearly three-quarters (73%) of global pharmaceutical organizations are actively planning, piloting, or deploying agentic AI initiatives. 

This widespread means agentic AI is no longer a futuristic concept, but a present-day imperative for staying competitive and delivering life-changing medicines faster.

For those not yet in the know, agentic AI is a sophisticated form of AI designed not just to analyze data, but to act autonomously, plan, reason, and execute complex, multi-step tasks. This goes far beyond traditional automation. Instead, agentic AI is about creating intelligent systems that can drive innovation, accelerate drug development, and optimize operations like never before.

So, which companies are leading the charge, and how exactly are these intelligent agents reshaping the pharma landscape? Let's dive into the specifics.

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For years now, the FDA has been making one point crystal clear to sponsors and CROs across our industry; they want the patient voice incorporated whenever possible in oncology trials.

The FDA's initiative is driven by the recognition that a patient's personal experience with a disease and its treatment is a unique and essential measure of a medical product's benefit and risk.

• Rationale: The FDA explicitly states that "patients provide a unique perspective on treatment effectiveness" and "some treatment effects are known only to the patient." Outcomes that truly matter to patients, such as functioning, quality of life, and the burden of side effects, are often best measured directly by the patient.
• Mandate: The Patient-Focused Drug Development (PFDD) effort, codified in part by the 21st Century Cures Act, requires the inclusion of such patient experience data in clinical research.
• Guidance series: To formalize this approach, the FDA has released a series of methodological guidance documents (the PFDD Guidance Series) that outline how stakeholders should collect, submit, and use patient input to inform medical product development.

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“Big corporations can’t rely on their internal speed to match the transformation that is happening in the world. As soon as I know a competitor has decided to build something itself, I know it has lost.” 

These candid sentences from Sanofi CEO, showcase one of the most common questions that’s at the forefront of every pharmaceutical company’s mind; whether to build or buy your way into the agentic and generative AI revolutions. 

In life sciences, many teams start with the same instinct. They see a capable large language model, stand up a proof of concept, and feel close to a breakthrough. For most of us, AI prototypes can look magical. A chatbot summarizes visit reports, drafts emails, or answers protocol questions in minutes. The experience is so strong that teams assume production is a short step away.

Unfortunately, the gap is much bigger than it looks. 

According to a recent MIT study, 95% of AI pilots will fail, as they note that “Only 5% of custom GenAI tools survive the pilot-to-production cliff, while generic chatbots hit 83% adoption for trivial tasks but stall the moment workflows demand context and customization.”

Like MIT’s example shows, moving from prototype to production in clinical research means building something validated, compliant, scalable, and integrated into real workflows. That takes far more than clever prompts. It requires domain grounding, continuous monitoring, retraining loops, robust tool orchestration, and evidence that the system is safe and auditable under regulations like GxP, HIPAA, and 21 CFR Part 11.

Many organizations only discover the hidden costs after they have committed. Internal teams often invest for two years, spend millions in sunk cost, and still never reach a dependable clinical grade system. The illusion comes from how easy it is to get an early demo working, and how hard it is to make that demo survive contact with trial reality. 

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Discover how Medable’s AI-powered oncology platform simplifies complex cancer trials by integrating eCOA, ePRO, and eConsent solutions—reducing trial time, improving patient retention, and enhancing data quality for faster, more efficient research.

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Learn how Medable is powering a decade-long, global long-term follow-up (LTFU) obesity study, achieving an impressive 97% patient retention rate without using a traditional EDC system all while delivering a compliant, scalable, and cost-efficient solution.

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It has become clear that our industry has reachedthe limits of human-only clinical development. As clinical trials have become increasingly complex, the endeavors that people alone can perform are no longer sufficient to generate the momentum needed to address the growing burden of human disease. This has led to longer drug development timelines and significant delays for patients. One large are of lost time is “white space,” definied simply as unproductive time caused by manual, sequential processes and fragmented data systems. Thankfully, a solution lies in agentic AI and its abilities to perform series of tasks.

Deployment of remote and virtual clinical trial methods and technologies, referred to collectively as decentralized clinical trials (DCTs), represents a profound shift in clinical trial practice. To our knowledge, a comprehensive assessment of the financial net benefits of DCTs has not been conducted

Research looking at mobile apps and how they may provide a meaningful access point for all stakeholders for symptom management.

By now, most people are familiar with ChatGPT and other general-purpose AI tools such as Perplexity. These horizontal AI systems have become commonplace, assisting users with tasks like composing emails, summarizing information, or generating creative ideas. Their adaptability across a wide range of domains demonstrates the power of general intelligence and transfer learning. 

However, in the high-stakes and highly regulated context of life sciences, it is important to ask whether such tools are suitable for clinical use. In this setting, a vertical agentic AI approach—purpose-built for specific domains—provides the precision, reliability, and compliance necessary for success. While both horizontal and vertical agentic AI play essential roles in the broader evolution of intelligent systems, it is the vertical approach that ensures the rigor and accountability demanded by life sciences applications.

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Explore how artificial intelligence (AI) is fundamentally transforming every facet of clinical trials, from initial protocol design and patient recruitment to data management and regulatory approval. This comprehensive guide provides an authoritative, in-depth look at AI's role in accelerating drug development and improving patient outcomes, with special focus on emerging agentic AI technologies.

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